SALES RELEASE Ligation System B|BRAUN Michael Chow Al Hicks Aesculap Marketing April 2003 Ligation System TABLE OF CONTENTS I. INTRODUCTION .................................................................................. 1 II. CUSTOMERS/MARKET ....................................................................... 1 III. PRODUCT INFORMATION .................................................................. 3 IV. FEATURES AND BENEFITS ................................................................ 5 V OFFERING AND PRICING ................................................................. 12 VI. COMPETITION ................................................................................... 13 VII. SALES STRATEGY............................................................................ 20 VIII.SALES TOOLS ................................................................................... 23 IX. CLINICAL DATA ................................................................................. 29 X. APPENDIX ......................................................................................... 36 Confidential - for internal use only Ligation System I. INTRODUCTION Ligating clips have been used in surgery for over 80 years. These clips were designed to perform two basic functions: ligation of a vessel and marking a specific surgical site which would later show up on X-Ray. Ligating clips are permanently implanted in the human body and are radiopaque. II. CUSTOMERS/MARKET According to IMS, the market in the United States for metal manual ligation clips is $55 million. Weck has a 70% market share and Ethicon has the remaining 30%. The key surgical procedures that consume the largest total of manual clips include Coronary Artery Bypass Grafting (CABG), Open Colon Resection, Femoral-Popliteal Bypass, and Carotid Endarterectomy. Table 1 illustrates the key surgical procedures utilizing ligating clips and estimates the total annual number of clips used per procedure. Table 1: Key Surgical Procedure Targets Procedure Relevant Sizes (2) Clips Total Clips 80% Mic,M,Sm, S/M,M,(L) 70% M,L (ML)(HOL) 80% ML,L(HOL) 75 21,000,000 15% 85% 17,850,000 50 14,175,000 50% 50% 7,087,500 50 1,200,000 50% 50% 600,000 10 400,000 50% 50% 200,000 100,000 110,000 20% M,L (ML)(HOL) 70% M,ML(HOL) 90% ML 10 8 700,000 792,000 50% 15% 50% 85% 350,000 673,200 830,000 98% ML(HOL) 8 6,507,200 95% 5% 325,360 30 35 35 60 20 50 50 20 702,000 567,000 315,000 1,200,000 300,000 1,350,000 750,000 1,280,000 0% 50% 95% 40% 10% 20% 25% 25% 100% 50% 5% 60% 90% 80% 75% 75% 702,000 283,500 15,750 720,000 270,000 1,080,000 562,500 960,000 # of Cases US(1) CABG 350,000 Colon Resection, Open Colon Resection, Lap Appendectomy, Open Appendectomy, Lap Cholecystectomy, Open Cholecystectomy, Lap Lymphadenectomy Splenectomy, Open Splenectomy, Lap Pancreatectomy Adrenalectomy Gastrectomy Vagotomy Gastric Bypass, Open 405,000 30,000 200,000 26,000 18,000 9,000 20,000 15,000 30,000 15,000 80,000 % Cases Use Clips 90% 90% 100% 100% 100% 90% 100% 80% M,L (ML) M,L (ML) ML M,L (ML) M,ML,L M,L(ML) M (M)ML,L 1 % % Total Manual Auto Manual Clips (3) (3) Confidential - for internal use only Ligation System Gastric Bypass, Lap Nissen Fundoplication Liver Resection Gastric Bypass Repair Lap Exploratory Adhesiolysis Lung Resection Femoral-Popliteal Bypass Carotid Endarterectomy Abdominal Aortic Aneurysm Other Vascular Bypass Vein Stripping Saphenous Perforator, Endo Open Nephrectomy Lap Nephrectomy Radical Prostatectomy Cystectomy Vericocele Repair Gynecological Oncology Hysterectomy Anterior Spinal Access Mastectomy ENT-Head/Neck Plastic Reconstructive 10,000 120,000 20% ML,L 50% ML 10 20 20,000 1,200,000 95% 98% 5% 2% 1,000 24,000 80% Sm, S/M, M 95% M,L (ML) 50 60 800,000 142,500 50% 25% 50% 75% 400,000 106,875 200,000 235,000 72,000 165,000 90% 80% 75% 85% 15 15 15 60 2,700,000 2,820,000 810,000 8,415,000 30% 20% 15% 10% 70% 80% 85% 90% 1,890,000 2,256,000 688,500 7,573,500 141,000 85% M, Sm, S/M 50 5,992,500 10% 90% 5,393,250 75,000 20% M,L 20 300,000 30% 70% 210,000 40,000 90% Sm,M,(L) 60 2,160,000 10% 90% 1,944,000 80,000 25,000 50% Sm,S/M,M 80% Sm,S/M 60 60 2,400,000 1,200,000 20% 60% 80% 40% 1,920,000 480,000 20 30 703,000 270,000 50% 95% 50% 5% 351,500 13,500 80 4,420,000 15% 85% 3,757,000 90 15 50 1,147,500 405,000 2,550,000 15% 0% 50% 85% 100% 50% 975,375 405,000 1,275,000 20,000 2,500 37,000 9,000 65,000 15,000 30,000 60,000 M,L (ML) M,L (ML) L,M M,L 95% M,ML,L 100% M,ML,(L) (HOL) 85% M,L (ML), (HOL) 85% M 90% M 85% L,M 624,000 120,000 15% L,M 50% M,Sm,S/M 15 15 1,404,000 900,000 50% 50% 50% 50% 702,000 450,000 120,000 40,000 30,000 90% Sm,S/M,M 90% Mic,Sm,S/M 90% Mic,Sm 60 40 30 6,480,000 1,440,000 810,000 30% 10% 0% 70% 90% 100% 4,536,000 1,296,000 810,000 (1) Bold is this column: Based on published source. Others are educated estimates. (2) Parenthesis indicates less likely use. Mic=SLS Micro Sm=Small S/M=SLS Small/Med. M=Medium ML=Medium Large L=Large HOL=Key Hem-o-lok Target (3) Figures in these columns are rough estimates 2 Confidential - for internal use only Ligation System III. PRODUCT INFORMATION Since 1992, the Vitalitec SLS ligating clip has been manufactured and marketed in Europe, as well as Asia, with great success. In fact, the Vitalitec SLS ligating clip system holds the leading market share for manual-load ligating clips in Great Britain, France, Germany and Asia. The success of the Vitalitec ligating clip system can be attributed to exacting quality engineering and product design targeted at superior clinical performance, emphasizing upgrades in key security-performance variables. These variables include design features calculated to improve: 1) visibility of the clip in the cartridge for precise pick-up, 2) security and stability of the clip in sturdy Vitalitec appliers, 3) and clip-grip surfacing designed for high-friction grip on vessel surfaces. Due to its quality and superior design, Vitalitec SLS clip success continues to grow every year, and with Aesculap’s strong sales organization, the product is poised for penetration of the United States market. Ligating Clips and Cartridges Aesculap offers six different sizes of ligating clips. The small/medium size is an Aesculap exclusive product. 6 and 24 clip cartridges are available. Clips are made from titanium. Titanium is clearly the metal of choice because it does not interfere with C.T. or M.R.I scans, has an extensive surgical implant history, and is less expensive than tantalum. The clips are widely spaced in a high contrast cartridge providing superior visibility for clip pick-up. The cartridges contain an adhesive backing which allow nurses to stick the cartridge near the surgical site or to their wrist. Size Micro Small Small Small/Medium Small/Medium Medium Medium Medium/Large Large Color White Yellow Yellow Lilac Lilac Blue Blue Green Orange Part # W6060-1 J1180-1 J1120-1 L5180-1 L5120-1 B2180-1 B2120-1 V3120-1 O3120-1 Packaging 30 cartridges of 6 clips / 180 clips 30 cartridges of 6 clips / 180 clips 5 pouches of 4 cartridges / 120 clips 30 cartridges of 6 clips / 180 clips 5 pouches of 4 cartridges / 120 clips 30 cartridges of 6 clips / 180 clips 5 pouches of 4 cartridges / 120 clips 20 cartridges of 6 clips / 120 clips 20 cartridges of 6 clips / 120 clips 3 Confidential - for internal use only Ligation System Clip Appliers Clip appliers for open surgery are offered in three different sizes (6”, 7 ½”, and 11”) and two different curves (curved and angled) to satisfy various surgeon preferences. The handles of the appliers are color coded to match the color of the clip cartridges. The appliers are stainless steel. The appliers contain sturdy and firm springs to minimize inadvertent squeezing of jaws. The jaws of the appliers are specifically designed to promote clip security. There is a V-to-V perfect fit of the clip-spine to the applier jaw groove. The jaws are specially treated to provide resistance to clip slip back and encourage secure pick up. Size Micro Color White 6” PW615-1R 7 ½” PW619-1R Small Yellow PJ115-1R PJ119-1R Small/M edium Medium Lilac PL515-1R PL519-1R Blue PB215-1R PB219-1R Medium/ Large Large Green PV319-1R Orange PO419-1R 4 7 ½” RA PWC6191R PJC1191R PLC5191R PBC2191R PVC3191R POC4191R 11” PJ128-1R PL528-1R PB228-1R PV328-1R PO428-1R 11” RA PJC1281R PLC5281R PBC2281R PVC3281R POC4281R Confidential - for internal use only Ligation System Endoscopic Clip Appliers The endoscopic clip appliers are stainless steel, reusable, and manually loaded. The lengths are 13” and different trocar diameters are needed for the various clip sizes. The appliers can be dismantled for easy cleaning. Size Small Small / Medium Medium Medium Medium / Large Large IV. Part # LCASLS1R LCASLS2R LCASLS3R LCASLS4R LCASLS5R LCASLS6R Outer Diameter 5.5 mm 5.5 mm 6.5 mm 10.0 mm 10.0 mm 12.5 mm FEATURES AND BENEFITS The following pages summarize the features and benefits of the Vitalitec ligating clips vs. three competitive product offerings (Weck Horizon, Weck Hemoclip, and Ethicon Ligaclip). 5 Confidential - for internal use only Ligation System Performance Category CartridgeLoading Applier PickUp of Clip Vitalitec SLS Weck Horizon Specific Vitalitec Advantage Easy-Loading of Chevron Clip Easy-Loading of Chevron Clip Widely-spaced clips on high-contrast Vitalitec cartridge provides superior visibility (esp. small) vs. Horizon Special Friction Surfacing on inner jaws for all sizes “V”-to-“V” “perfect fit” of clip-spine to applier jaw groove Special Friction Surfacing on Inner Jaws of Red Small Appliers only; V-to-V “perfect fit” of clipspine to applier jaw groove Facilitate more secure pick-up (“feel the friction pick-up”) Resistance to slide-back in applier during application to vessel Firm applier springs Friction treatment on jaws High-visibility cartridges Two and possibly three different patterns Resistance to Dropping of Clips (key ligating clip problem) Proper clip closure, vs. gaps and scissored closure Positive-traction treatment on jaws V”-to-“V” “perfect fit” of clip-spine to applier jaw groove Robust jaws and jaw profiling resist pressures that can twist jaws Friction treatment of appliers is available on Small Red appliers only Pointed jaw profile of small applier may be more susceptible to catching in tray perforations 6 Weaker spring tensions on Horizon appliers based on age and pattern leads to inadvertent squeezing that causes dropped clips Positive-traction friction treatment on Vitalitec appliers helps to maintain the clip in proper position in the applier discouraging dropped clips Universal positive-traction treatment across all sizes and lengths of appliers encourages proper positioning of clip in jaws of the applier and therefore proper closure Small jaw of Horizon applier is profiled to allow easier insertion into mesh of instrument tray or basket and subsequent twisting of jaws, which causes scissoring of clips Confidential - for internal use only Ligation System Performance Category Vitalitec SLS Weck Horizon Clip sizes Only four size clips The small size clip is set very narrow on the Small Red wide slot applier, apparently to fight a slide-back problem. Surgeons may find it too narrow for easy use on vessels Grip on tissue Offers six size clips, including the Micro and exclusive SmallMedium sizes The Small clip mouth opening allows slightly more space for vessel insertion than the Horizon Small clip in the Red system Positive-grip Microserration design Specific Vitalitec Advantage Smooth surfacing with a narrow internal groove 7 Micro size: Likely to be a popular choice for tiniest radial artery branches, many distinctively smaller (1mm or less) than other branches ligated in cardiovascular graft harvesting. Micro clip is also a possible choice for some saphenous vein branches and certain neurosurgical placements and free flap plasticreconstructive surgery, as well as pediatric surgery Small-Medium: Only slightly wider and deeper than the SLS small clip (about 1 mm.), it holds significantly more tissue. It may become a popular choice for IMA surgery, which generates some surgeon complaints about the narrow seating of the Horizon Red Small. This exclusive clip provides ammunition to break GPO contracts! Dr. Peter Samuels, designer of the original Hemoclip clip, first suggested the idea of a clip with teeth for enhanced grip Confidential - for internal use only Ligation System Performance Category CartridgeLoading Applier PickUp of Clip Vitalitec SLS Easy-Loading Chevron Clip Weck Hemoclip Specific Vitalitec Advantage Clip is Friction-Fit on Cartridge Seat Easy-Loading SLS vs. Weck Hemoclip, for less damage to appliers Special Friction Surfacing on inner jaws for all sizes “V”-to-“V” “perfect fit” of clip-spine to applier jaw groove No special surfacing of inner jaws; Round spine of clip sits on Vshaped groove of applier— two-point contact only Doubly-improved pick-up traction and resistance to slide-back compared to a system that is neither perfect-fit nor tractionenhanced in the jaw (Hemoclip Traditional) Firm applier springs Friction treatment on jaws High-visibility cartridges Longest lineage of in-place appliers in the field Loading stresses of a rigid friction-fit cartridge Compare the all-new Vitalitec applier tension to the various sizes and vintages of Weck appliers! Combine that with the Vitalitec SLS (Soft Loading System) and you maximize applier integrity and likely reduce the incidence of twisted jaws (and scissored clips), or spread jaws (and clip-slide back) Resistance to Dropping of Clips (key ligating clip problem) 8 Confidential - for internal use only Ligation System Performance Category Proper clipclosure, (vs. gaps and scissored closure) Vitalitec SLS Positive-traction friction treatment on jaws combined with V-to-V fit of clip in jaws, helps to maintain clip in the proper position in applier jaws for proper closure Sturdy jaws and profiling resist pressures that can twist jaws and create twisted, scissored clips Weck Hemoclip Specific Vitalitec Advantage Clips rounded at the clip spine, The Vitalitec benefits of positive traction and sit in a V-shaped groove in the perfect fit contrast to the Hemoclip applier—an unstable Traditional instability of clip-applier-fit and mismatch that adds little to Small jaw construction security of grip or resistance to Vitalitec appliers offer solid-jaw construction slide back behind the clip closure area to eliminate the closure hazard posed by the Weck Window Small applier jaws are especially weak and vulnerable Appliers are troubled by a large gap just behind the clip closure area, called the Weck Window. A clip which slips back into this area can close with a large-loop gap Clip Size Offers six size clips, including the Micro and exclusive SmallMedium sizes Four clip sizes only. The Small clip size is sometimes rejected as too wide by some surgeons who prefer the Ethicon clip for its slightly smaller width Offering of additional clip sizes will be a particular advantage in cardiovascular surgery where grafts from the Radial Artery, Internal Mammary Artery (IMA) and Saphenous Vein bridge the aorta to the coronary arteries, often relying on clips to hold the branches of these critical conduits under extremely strong pressure Grip on tissue Positive-Grip Microserration design Narrow channel design provides smooth surfacing on each side of the groove Dr. Peter Samuels, designer of the original Hemoclip clip, first suggested the idea of a clip with teeth for enhanced grip 9 Confidential - for internal use only Ligation System Performance Category CartridgeLoading Applier PickUp of Clip Vitalitec SLS Easy-Loading Chevron Clip Ethicon Ligaclip Easy-Loading V-Profile Clip Specific Vitalitec Advantage Vs. Ethicon: Chevron-shaped clips maintain their shape in cartridge for proper loading with less applier dependence Special Friction Surfacing on inner jaws for all sizes “V”-to-“V” “perfect fit” of clip-spine to applier jaw groove Exterior grooves on clip necessary to aid pick-up of “V”-shaped design [“V” refers to clip- profile, not the spine, which is flat-wire] Grooves on inside of jaw match exterior clip grooves The Vitalitec clip is a preformed chevronshaped clip(constructed from a beam of wire rather than a ribbon of wire like the Ligaclip) and is designed to offer more stable loading into the applier and therefore for more consistent closure as well Firm applier springs Friction treatment on jaws High-visibility cartridges The V-shaped profile of the Ethicon Ligaclip clip is notched on the exterior legs in order to take a chevron shape in the applier. This weakens the clip and may destabilize it Ethicon springs are not as firm as Vitalitec Firm Vitalitec springs prevent inadvertent pre-closure squeeze that can produce clip dropouts Positive-traction friction treatment on Vitalitec appliers helps to maintain this preformed chevron-shaped clip in proper position in the applier, helping to discourage dropped clips and promoting proper closure Resistance to Dropping of Clips (key ligating clip problem) Proper clip closure, vs. gaps and scissored closure Positive-traction friction treatment on jaws combined with V-to-V fit of clip in jaws, helps to maintain clip in the proper position in applier jaws for proper closure Sturdy jaws and profiling Jaws are formed into a pointed profile Exterior grooves do not help much in preventing clip slipback or clip-drops 10 The Vitalitec benefits of positive traction and perfect fit encourages proper positioning of clip in jaws of the applier and therefore proper closure Small Ethicon jaw profile allows easier insertion into perforations of instrument tray or basket and subsequent twisting of jaws, which causes scissoring of clips Confidential - for internal use only Ligation System Performance Category Clip sizes Grip on tissue Vitalitec SLS Offers six size clips, including the Micro and exclusive SmallMedium sizes Ethicon Ligaclip Only four size clips; Small clip is often preferred to Weck Hemoclip Small because of its narrower width and thinner wire profile Specific Vitalitec Advantage Micro: May be superior choice for tiniest radial artery branches, which have been called “spider vein size”. Micro clip is also a possible choice for some saphenous vein branches, certain neurosurgical placements free flap plastic-reconstructive surgery, as well as pediatric surgery Small-Medium: Only slightly wider and deeper than the SLS small clip (about 1 mm.), it holds significantly more tissue. It may become a popular choice for IMA surgery, which generates some surgeon complaints about the narrow seating of the Horizon Red Small. This exclusive clip provides ammunition to break GPO contracts! Positive-Grip Microserration design The system now on the market, Ethicon Ligaclip Extra, essentially copies the internal serrations of the Weck Hemoclip clip 11 Dr. Peter Samuels, designer of the original Hemoclip clip, first suggested the idea of a clip with teeth for enhanced grip Ethicon’s smooth-surface grooving is no design match for Vitalitec Micro-serrations Confidential - for internal use only Ligation System V. OFFERING AND PRICING The customers will have the option to purchase their clip appliers or accept a consignment agreement. Since the purchase of clip appliers requires an upfront cost, we believe most high volume hospitals will choose the consignment option. Weck has been frustrating its customer base by boldly raising clip prices over the years and charging customers for new appliers. Ethicon historically has high prices for their product offerings. Aesculap will utilize a Fair Pricing Program to limit future price increases on ligating clips and appliers. The following bullets are responses to the question: Why Choose Aesculap for your ligating clips needs? World’s Largest Surgical Instrument Company: Reusable clip appliers are surgical instruments! As the largest surgical instrument manufacturer in the world, Aesculap is an expert in the technical issues that affect mechanical hemostasis. Aesculap’s experience includes both surgical hemostats and neurosurgical aneurysm clips (a type of hemostatic clip). In fact, Aesculap manufactures the industry’s leading endoscopic ligating clip applier for Weck! Superior Repair Service: Aesculap has been repairing Weck ligating clip appliers for years. Hospitals understand Aesculap’s core compentency in instrument repairs. Centrally Located Repair Depot: Aesculap’s repair operation is optimally located to promptly service all regions from a central hub facility in St. Louis, Missouri, that is home to our applier repair specialists. Aesculap Service Applier Program (ASAP): Your Aesculap representative is committed to providing a program of regular service visits to minimize your applier downtime awaiting repairs. Free-Applier Consignment Program: A free applier consignment program is available for certain hospitals based on annual clip usage and approved by marketing. This program will you be able to replace all the appliers on your sets with brand new appliers, but you will also be able to select between free-applier and purchased applier programs! Fair-Pricing Program: Aesculap knows how frustrating it is to absorb strong price increases on surgical ligating clips and appliers. The goal of our Fair Pricing Program is to limit future price increases on ligating clips and appliers. Customers selected Aesculap for applier repairs despite the fact that Aesculap is not an authorized repair vendor for Weck. 12 Confidential - for internal use only Ligation System VI. COMPETITION The ligating clip market in the United States is dominated by two competitors, Weck and Ethicon. Weck has approximately 70% market share with Ethicon claiming the remaining 30% share. A cross reference sheet for the clips and appliers have been provided to identify competitive part numbers to the Aesculap equivalent. 13 Confidential - for internal use only Ligation System Competitive Ligating Clip Cross Reference Sheet Aesculap Weck J1180-1 J1180-1 J1120-1 J1120-1 30 180 5 120 S/M S/M CardioPak L5180-1 L5120-1 30 5 180 120 N/A N/A Medium Med CardioPak Reusable Auto Applier Reusable Auto Applier B2180-1 B2120-1 30 5 180 120 2200 2204 30 25 180 600 2100 2104 30 25 180 600 523800 523700 527200 527203 20 10 10 10 200 250 200 100 523300 523100 20 10 200 250 Med/Large Med/Large V3120-1 V3120-1 20 20 120 120 3200 3204 20 15 120 360 3100 20 120 523860 523760 16 20 160 200 523360 523160 16 20 Large Large O4120-1 O4120-1 20 20 120 120 4200 4204 20 15 120 360 4100 20 120 523870 523770 12 10 120 150 523370 523170 12 10 1200 1201 1204 1205 30 30 25 25 180 180 600 600 1100 1101 1104 1105 30 30 25 25 180 180 600 600 N/A N/A 14 Part # N/A Hemoclip Titanium Cart/ Clips/ box box Weck SMALL Wide Slot/Strongpoint SMALL CardioPak Wide Slot/Strongpoint Part # N/A Horizon Tantalum Cart/ Clips/ box box Weck Micro Part # N/A Horizon Titanium Cart/ Clips/ box box Weck SLS-Clip® Titanium Cart/ Clips/ Part # box box W6060-1 30 180 Part # N/A Hemoclip Tantalum Cart/ Clips/ box box Ethicon Part # N/A Ligaclip Titanium Cart/ Clips/ box box 523835 24 240 523335 24 240 LT100 36 216 523735 12 300 523135 12 300 LT102 15 300 LT200 LT202 36 15 216 300 160 200 LT300 18 108 120 150 LT400 18 108 N/A N/A N/A N/A N/A N/A Confidential - for internal use only Ligation System Competitive Clip Applier Cross Reference Sheet Aesculap SLS-Clip® Appliers Micro Curved Angled 15cm (6") PW 615-1R 19cm (7.5") PW 619-1R SMALL Curved Angled 15cm (6") PJ 115-1R 15cm (6") Wide Slot 19cm (7.5") PJ119-1R 19cm (7.5") Wide Slot 28cm (11") PJ128-1R 28cm (11") Wide Slot Small Medium Curved Angled 15cm (6") PL 515-1R 19cm (7.5") PL 519-1R Medium Curved Angled 15cm (6") PB 215-1R 19cm (7.5") PB 219-1R 28cm (11") PB 228-1R PBC 228-1R Med / Large Curved Angled 19cm (7.5") PV 319-1R 28cm (11") PV 328-1R PVC 328-1R Large Curved Angled 19cm (7.5") PO 419-1R 28cm (11") PO 428-1R POC 428-1R Weck Horizon Appliers Curved Angled N/A N/A Curved Angled 137061 137062 137081 137085 137082 137086 137111 137112 137116 Curved Angled N/A N/A N/A N/A Curved Angled 237061 237081 237085 237111 237115 + 6 Curved Angled 337081 337085 337111 337115 Curved Angled 437081 437085 437111 437115 15 Weck HemoClip Plus Appliers Curved Right 45º Angled Angled N/A N/A 533140 534140 533150 534150 533151 534151 Curved N/A N/A Curved 533109 533110 533111 Curved 533165 533166 Curved 533175 533180 533152 534152 Right N/A N/A Right 533105 533106 Right 533167 533168 Right 533177 533178 533153 534153 45º N/A N/A 45º 533108 45º 533164 45º 533173 533181 Ethicon Ligaclip Appliers Curved Angled N/A N/A Curved Angled LX105 LX107 LX110 LX130 Curved N/A N/A Curved LX205 LX207 LX210 Curved LC307 LC310 Curved LC407 LC410 Angled N/A N/A Angled LX230 Angled LC330 Angled LC430 Confidential - for internal use only Ligation System Competitive Endoscopic Clip Appliers Cross Reference Sheet Lap Appliers Small Small / Medium Medium Medium Medium / Large Large 33cm 33cm 33 cm 33 cm 33cm 33cm Aesculap Curved Trocar LCA SLS 1 5.5mm LCA SLS 2 5.5mm LCA SLS 3 6.5mm LCA SLS 4 11mm LCA SLS 5 11mm LCA SLS 6 12.5mm Weck Curved Trocar Ethicon Curved Trocar 238110 238200 338110 438110 EL214 11mm 5-7mm 10mm 11mm 16 EL314 EL414 Confidential - for internal use only Ligation System The table below is a summary of key performance features of the Vitalitec clip vs. the major competing product lines such as Weck Horizon, Weck Hemoclip Traditional, and Ethicon Ligaclip. Performance Feature Fit of Clip in Applier Jaw Vitalitec Horizon V-to-V fit V-to-V fit Surfacing of Applier Jaws Special Traction Treatment All Sizes Special Traction Treatment Small Red Applier Only Clip Visibility on Cartridge Easy-vision cartridge for precise pick-up of clips: contrast and spacing Narrow spacing of clips on cartridge, clip deep in seat Ease of Loading Easy-Loading of chevron-shaped clip Difficult to see clips vs. empty slots on Small: narrow spacing, shadowing, poor background contrast Easy-Loading of chevron-shaped clip Yes No Yellow Small applier has weak jaw; Red is strong, but pointed design Very flimsy and pointed Strong but pointed 4 4 4 Backing Yes Adhesive Small Applier Sturdy jaws; Jaw Small profile Configuration designed to help resist insertion in tray mesh and subsequent twisting of jaws Size of Clips 6, extra clips for cardiovascular, micro, plastic 17 Hemoclip Traditional Rounded Clip Spine in VShaped Applier Groove No Special Traction Treatment Friction-Fit of Clips on Cartridge Ethicon Ligaclip Flat Wire in Flat Jaw Ridges on internal surface of applier to match external ridges on clip—to aid pick-up, not to resist slide-back Only equal to Weck in slide-back resistance Broad flat wire provides good visibility, though spacing between clips is not wide Easier than Hemoclip Traditional, but not as easy as Vitalitec; Clip in V-profile in cartridge, subject to misshaping No Confidential - for internal use only Ligation System Metal Composition Titanium Applier Spring Features Consistent, firm springs to fight clip dropout, unlatch for cleaning Laparoscopic Applier Yes, good quality, small, medium, medium-large, and large; Small and medium for saphenous Happy to customize for an extra fee Special Appliers Loading Base as option Yes Titanium About half of Nearly all clips clips are titanium, a few still tantalum or stainless steel stainless steel More than one Many vintages Many different vintages pattern of applier of appliers in the in the field undermine in the field field, some quite consistency; almost no appliers open for creates weak leading to cleaning, though a new inconsistency, clip drop-out, version does most springs not especially when as firm, unlatch combined with for cleaning stresses of friction-fit cartridge, unlatch for cleaning Yes, good quality, None Poorly designed medium, mediumlaparoscopic applier for large, and large; medium-large clips: Pistol grip asymmetrical jaw saphenous closure; limited 180 applier for small, degree tip rotation; medium, longer Difficult Multi-Angle Access (MAA) applier for IMA— Not popular; Spinal Access applier for Small and Medium clips, exactly the same applier as standard long applier, except for gold rings; long delays and heavy red tape on customizing; extra fee No 18 360-degree nonlaparoscopic appliers are no longer popular; no reported customizing No reported customizing Yes Yes Confidential - for internal use only Ligation System Clip Remover? No, use blunt nosed needleholder No, use blunt nosed needleholder Yes, for open surgery Yes, but the remover has sharp teeth that can tear vessels Repair Central location for efficient service to all US-- St. Louis, Missouri East Coast East Coast East Coast Applier Availability Based on Commitment and Pricing Free swaps to start accounts. Appliers mostly purchased now; accounts sometimes serviced with rep “trunk stock”. These largely second-hand appliers can worsen performance problems Free swaps to start accounts. Appliers mostly purchased now; accounts sometimes serviced with rep “trunk stock”. These largely secondhand appliers can worsen performance problems Free swaps to start accounts, though it is not clear that these are always new appliers. Other appliers mostly purchased 19 Confidential - for internal use only Ligation System VII. SALES STRATEGY With the anticipated strong demand for this product and upfront costs invested in consigned appliers, an account qualification process will be utilized to prioritize opportunities. Marketing has developed a Four Step process to be followed. These forms are included in the Appendix of this Marketing bulletin and this process is summarized below: Step 1: Quotation Worksheet – Information needed in order to provide pricing such as clip volume, applier volume, duration of contract, and repair expectations. The pricing strategy is to price the product below competitive averages. Step 2: Qualification Checklist – After the account approves the price structure, the qualification checklist needs to be completed. This checklist includes information such as the requested start date of the evaluation, # of appliers requested, and # of procedures required. Approval from your Regional Sales Director is required prior to submitting Step 2. Step 3: Customer Evaluation Agreement – Signed agreement from customer indicating that if the evaluation is successful, the customer intends to purchase and convert to the Aesculap ligation system. Includes the evaluation criteria that the hospital will use. Step 4: Purchasing and Consignment Agreement – Signed agreement that customer agrees to pricing for a specified contract period (typical is three years). Also the quantity of consigned appliers is indicated with the statement that consigned appliers must be returned if the customer no longer wishes to purchase the clips from Aesculap. A charge of $110 per applier is due to Aesculap for any applier not returned or returned in non-repairable condition. A recommended approach for converting an account from a competitive product to the Aesculap ligating clip is provided below. I. Prospecting, Investigate—With Nurses, Surgeons, Other Reps, Other Hospital Personnel: Uncover Need to Convert A. Current Usage B. Satisfaction Level C. Contracts II. Study Aesculap Positioning Guide on Target Competitive System In This Account A. Topics B. Probes C. Comparative Advantage III. Meeting With OR Supervisor (followed by meeting with Purchasing Administration on Worksheet) A. Confirm Info on Hospital B. Probes for Advantage 1. Satisfaction Level, Problems 20 Confidential - for internal use only Ligation System 2. Contract and Pricing Situation a) Current Contract Term b) Provisions, Required Term Provisions for Future Contracts C. Demo 1-3 Key Product Advantages D. Explain Advantages 1. Positive interface (or “security interface”, etc.), relating theme to key individual comparative advantages 2. Fair Pricing, to counter ligating clip price increases of recent years. Display paperwork to compute pricing offer, while expressing confidence Aesculap can save account money. a) Applier Consignment Program b) Applier Purchase Program 3. Aesculap Service Program: Explain key commitments of warranty and service program . 4. Exclusive sizes: Weck and Ethicon do not offer the micro and small-medium sized clips. This will allow the hospital to break the current contract. IV. Follow-up Meeting A. Evaluation Set-up 1. Decide with OR Supervisor on Storage and Availability of Evaluation Appliers (Peel Packs—in cabinets, OR sterile storage?; in surgical sets; in separate trays, etc.) a) Point Person for Applier Readiness and Care b) Handling of Appliers c) Checking of Appliers After or Before Each Use d) Identify key CS staff to in-service 2. Establish Duration—Start and End Dates 3. Get buy-in on feedback forms goals. What needed for success? Key surgeons? Chief? Percent of surgeons? Committee? What are standards of committee? Do you meet and summarize with committee? What dates? 4. Number of Appliers and Clips Needed? 5. Establish In-Service and Feedback Process (Loading technique; Applier-Clip Security Demonstration; Serrations Under Magnifying Glass; Tubing): a) Meetings? b) Hall Demo Stations? c) Lounge Displays? d) Can you hang flyers? e) In operating room as info resource? 6. Submit Worksheets to Aesculap [Michael Chow] [Will be returned with quotation for account, with purchased and consigned appliers.] 7. Schedule Aesculap Ligating Clip Supporting Personnel for Evaluation: Cox, Hicks, Knupp, Chow if needed 8. Hospital Customer Approves Pricing (OR, Materials Management) 21 Confidential - for internal use only Ligation System 9. Authorize Contact with Key Approval Target Surgical Users (Surgeons and PA, Head Nurse). Get Supervisor Buy-In on Approval Forms Before Submitting Them for User Signatures. V. Clinical Coordination A. Key Surgical Users 1. Discuss Prospective Evaluation Beforehand if Possible 2. Demonstrate Product and Explain Comparative Advantages 3. Establish goals in surgery: what to expect (usually just acceptability, with target benefits noticeable long-term: reduced applier damage, reduced clip dropout, precise clip closure, etc.) 4. Mention Prospective Cost Savings to Account 5. Evaluation Schedule B. Supporting Personnel 1. Demo Product 2. Instruct in Proper Loading Technique—Critical! a) Rule 1: Don’t use grip that can squeeze the applier b) Rule 2: Respect the angle of the applier—jaw moves straight down over clip; applier shanks are angled vs. cartridge to make this happen. c) Feel the applier-clip positive(or security)interface as it loads! VI. Clinical Evaluation A. Visit day before start of evaluation--Reminders 1. OR Supervisor meeting a) Goals: Demonstrate acceptability; Many advantages noticeable longer term. b) Logistics: appliers, in-services, approved location for you and other Aesculap personnel during evaluation: Operating room? Lounge? Hallway? c) Start Time Review d) OR schedule for next day 2. Visit “Point Person” a) Applier Availability Logistics: (Provide appliers for cleaning and sterilization now or previously.) b) In-services scheduling c) Feedback Logistics 1) Evaluation forms 2) Filling them out d) Applier Care and Turnaround B. Coordinate with arriving or expected support personnel. Discuss strategy: Technical product knowledge, advantages, account leverage points. C. Evaluation Start 1. Arrive early with Aesculap team and your support materials: Paperwork, fliers. 2. Smile and display confidence in your excellent ligating clip product. 3. Touch base with OR supervisor and Point Person. 4. Situate All Aesculap Support Personnel with appropriate forms. Have evaluation personnel complete Aesculap Evaluation Form (See Appendix). 22 Confidential - for internal use only Ligation System VIII. SALES TOOLS Sales Probes Ligation System Sales Brochure (DOC 426) Sales Rep Sample Kit 23 Confidential - for internal use only Ligation System Vitalitec Positioning Guide: Points Conveying Your Advantage to the Customer Primary Guide: Bullet Version 1-Competitive Product 2Customer 3-Probe 4-Customer Response Horizon OR Supervisor Tell me about your experience with Weck clips We have had a very positive experience with Weck Horizon OR Supervisor What performance features of a ligation system are important to you? We experience dropped clips OR Supervisor Surgeon 5-Positioning Points Emphasize key performance features: 1. Visible cartridge for precise loading of clips 2. improved positive-grip surface on clips 3. specialized process on applier jaw for positive grip on clip 4. Regular servicing by instrument specialists, consignment inventory, quick turnaround from centrally located facility (St. Louis) Perfect-fit Special friction treatment on the jaws of all-size appliers for better traction on clip Springs of our appliers very sturdy and uniform Sturdy but trim jaws We have trouble loading the clips Clips are widely-spaced on the cartridge Good-contrast backdrop colors Better loads fight dropped clips “We sometimes experience scissored clips” Jaw profile of our small clip jaws resists insertion into instrument tray wire mesh Serrated flat clip surface provides stability of clip legs (vs. smooth surfaces of Horizon) 24 Confidential - for internal use only Ligation System 1-Competitive 2Product Customer 3-Probe 4-Customer Response 5-Positioning Points Horizon What is the optimal clip for IMA branches?” “The Horizon red is a little small for the IMA branches” What are your thoughts regarding ligation clips vs. sutures? “I trust suture more, of course, in some settings. But clips have worked relatively well over the years. I don’t see how you could improve them” “A couple of surgeons like the Hem-o-lok clip. Do you have anything like that?” Horizon Horizon CV Surgeon OR Supervisor Surgeon OR Supervisor Surgeon Are you using any non-metal clips? Tell me where and why 25 The Vitalitec Small may be a little more encompassing for the IMA branches Vitalitec also offers a Small-Medium, which is just slightly larger than Small, and a Micro clip—for tiny vessel branches like Radial Artery branches Dr. Peter Samuels, designer of the Weck Hemoclip, proposed some years ago the idea of teeth on a clip-- for enhanced grip Weck internal clip surfaces smooth in comparison to the Vitalitec clip surface Vitalitec: Multiple serrations for better grip. 10 years in Europe, great response We specialize in metal clips (preferred for the vast range of surgery) Hem-o-lok clips are priced up to 4-5 times metal clip prices Confidential - for internal use only Ligation System 1-Competitive 2Product Customer 3-Probe 4-Customer Response Hem-o-lok Surgeon What features of Clip security the Hem-o-lok clip do you find beneficial? Hemoclip Traditional OR Supervisor, or Head Nurse Do you experience any issues with the maintenance program of your appliers? We do have a regular flow of repairs 26 5-Positioning Points The Vitalitec clip shares something in common with the Hem-o-lok clip: tiny serrations to achieve security on vessels Vitalitec clip can be adjusted, achieving tighter closure with more pressure The Hem-o-lok clip closes to one closure point and cannot be adjusted tighter past that point: a “one-closure-fits-all-approach” for each clip size. That is very different from most clips and from suture, both of which are adjusted by the surgeon Vitalitec clips have many more teeth and are trimmer Vitalitec clips are X-Ray detectable, so you can use them as markers Vitalitec clips cost a fraction of what Hem-o-lok clips do The Vitalitec system is designed to minimize repairs— Soft-Loading-System to reduce stress on appliers, vs. the friction-load system of Hemoclip Traditional: the oldest system Small appliers with sturdy jaws that won’t get caught in tray or basket mesh Sturdy springs Clip cartridge to facilitate precise load vs. narrow seats of Small HT Aesculap Service Applier Program Confidential - for internal use only Ligation System 1-Competitive 2Product Customer 3-Probe 4-Customer Response 5-Positioning Points HT-Tantalum Do you experience any issues using tantalum clips? 1) We’ve used it for a long time—it closes well; or 2) I thought we were using titanium I like stainless, because it is the strongest metal HT-Stainless Steel Hemoclip Traditional Hemoclip Traditional Surgeon Surgeon OR Supervisor Surgeon OR Supervisor Do you experience any issues using stainless steel clips? Which system is more cost effective automatic disposable laparoscopic appliers or reusable manual load? Do you buy or consign appliers? No one ever asks for a manual laparoscopic applier. The doctors seem satisfied with the disposables In recent years, yes. It doesn’t matter though, because we are preparing to upgrade to Horizon 27 Titanium is the most commonly used metal today for ligation clips Titanium causes fewer problems on both CT and MRI scanning Tantalum is usually priced much higher than titanium Vitalitec titanium clips have a long record of security in surgery designed to withstand maximum systemic pressures. 10 years Europe The MRI deflection of stainless steel is 35-50X that of titanium (though not proven harmful) That may be due to the fact that you are using a system (HT) that does not offer a manual-load laparoscopic applier; the Weck rep can’t sell the concept Only a few clips are placed in lap chole You pay about $100 for a disposable lap applier, for placing 4-6 clips ($16-$25 per clip). Clips for manual appliers cost about 70 cents-$1 per used clip Vitalitec offers a plan that allows you to pay for clips, with free appliers on consignment Evaluate Vitalitec at the same time to save money on Fair-Pricing Program. Get a clip system with equal or better features than Horizon Our Aesculap Service Applier Program provides a program of regular service visits to minimize applier downtime awaiting repairs. All appliers are repaired by instrument professionals Confidential - for internal use only Ligation System 1-Competitive 2Product Customer 3-Probe 4-Customer Response 5-Positioning Points Ethicon Ligaclip OR Supervisor Tell me about your experience with Ethicon clips They don’t complain. [If complaint go to that topic] Ethicon Ligaclip Head Nurse Surgeon Ethicon Ligaclip Head Nurse Surgeon What performance features of a ligation system do you feel are critical? Same as above Clip Pick-up Closure 28 Vitalitec clips are both easier to load and preformed for precise closure Our Aesculap Service Applier Program provides a program of regular service visits to minimize applier downtime awaiting repairs. All appliers are repaired by instrument professionals Vitalitec appliers open for cleaning at the boxlock. Most Ethicon appliers do not Vitalitec’s clip is a pre-formed chevron to give you a more consistent load Ethicon’s clip is “V”-shaped in the cartridge; only becoming chevron-shaped in the applier due to two exterior notches which weaken it at two points Ethicon’s Ligaclip Extra clip incorporates two notches in the exterior of the clip legs The notches weaken the clip at two key points in an effort to imitate a true Chevron-shaped clip Vitalitec clips are Chevron-shaped in the cartridge for stability, loading and closing Confidential - for internal use only Ligation System IX. CLINICAL INFORMATION Clip Size Leading Use or Strong Potential Details Micro CABG, IMA; Radial Artery Harvest The Radial Artery is the newest frequently used graft in CABG Micro PlasticReconstructive FreeFlap(30,000) Plastic Reconstructive Surgeons started asking for Micro clip 20 years ago Details Details The Radial Artery branches are very tiny, about 1 mm diameter Shallow nature of the surgery aids visibility of the clip. Small clips used now, but micro would fit and might be preferred Free-Flaps are When a plastic tissue reconstructive transfers to surgeon tells you cover tissue he or she does free deficits from flaps “all the time,” trauma or he may mean 3-4 a surgery month Thyroid surgery Very small Micro Shallow nature feeding branches of the surgery aids visibility of the clip Italics indicate potential or prospective use. The surgeon is the final authority on selection of clips for particular vessels. Security of all ligating clips should be confirmed after placement. 29 Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Small-Cardiovascular IMA (150,000) part of CABG (350,000) Small—ENT, Head and Neck Small—General Details Details Details IMA is the internal mammary artery The IMA is attached to a coronary branch to perfuse it; can be unilateral or bilateral. Small clips are currently the most popular for IMA ENT, Thyroid, Maxillary Artery (with pistol applier), head and neck for trauma, and palliative surgery ENT surgeons are more conservative about clips, but do use them Mastectomy (Breast) (120,000) Modified radical mastectomy is less destructive than radical Lymphatic node ligation becoming more thoroughly practiced to prevent metastases of cancer: near vessels— vascular, breast Surgeons currently rely on medium and small 30 Axillary dissection includes lymphatics Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Small-MediumCardiovascular, Vascular Carotid Endarterectomy Saphenous Vein Harvest, Internal Mammary Harvest Small-Medium— Abdominal Liver Resection (20,000) Small-Medium Markers Details Details Small generally used for IMA. S/M can encompass slightly more tissue, particularly with its length The liver In a body is liver(lobe) perforated by transplant, tiny thinthe liver is walled veins. incised, as in trauma cases Titanium is Medium the ideal usually used; marker: S-M would minimum cause less interference interference CT, MRI Details S/M may be a more appropriate size than Medium on some branches of Carotid and Saphenous vein 31 The tiny veins are a challenge for Medium clips. Opportunity for S-M Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Medium-- Saphenous Vein Harvest Saphenous is still the most popular conduit, because IMA will only handle one-two graft cases General Abdominal (500,000+): Esophageal (25,000); Spleen(27,000), open and lap General abdominal includes gastrectomy, vagus ligation, exploratory laparotomy, open gall bladder, colon/rectal, small intestine, appendectomy (300,000), anterior spinal access Cardiovascular Medium-General Details 32 Details Details Medium has been used as the one-size that fits all branches, though a gradual trend has seen the growth of mixed Medium and Small in some OR‘s If clips are used on both the donor and graft side, then saphenous tributaries are a big challenge for Medium clips, because some branches are as small as 1 mm in diameter Vascular A large includes portion of carotid Weck clips endarterectomy are comprised (100,000), of tantalum or femoral stainless popliteal steel, which bypass can cause (75,000), aortic scanning bypass problems on (50,000), MRI perforator (Stainless) or surgery in leg CT scanner (25,000); (Tantalum) endovascular repair; Varicose vein excision (5075,000) Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Details Medium-Vascular Vascular(400,000): Carotid, FemoralPopliteal; Other femoral bypass; AAA; Saphenous Perforator; Vein stripping Urological: Nephrectomy Prostatectomy Cystectomy Vascular surgeons use a lot of clips, but they tend to be more casual about the subject than cardiovascular surgeons Specialized: ENT, Plastic Head/Neck; Liver; Pancreas; Breast; Lymphatics; Gyn Oncology (see under Large) Plastic and Reconstructive Surgeon; ENT; General Surgeon Medium-Urology Medium— Other Specialties 33 Details Details Vascular surgeons do not carry as much weight in the clip decision as cardiovascular surgeons Donor Nephrectomies grab the headlines, but only 6,000 done annually. About 40,000 done for pathology May be handled by general surgeon Plastic and Reconstructive and Head and Neck surgeons perform jaw and other reconstructive work that can utilize clips Pancreatectomy Only about 10,000 cystectomies done—for cancer removal—but up to 100 clips per case, mostly Medium. Might be some interest S-M (25,000) can utilize a large number of medium clips. “Whipple” procedure is one variety of this reconstructive work Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Details MediumLarge-General Laparoscopic Cholecystectomy (830,000 US) 95% with Automatic clip appliers MediumLarge-Urology Nephrectomy A target procedure for Weck HOL MediumLarge— Urology. Prostatectomy (60,000-80,000) Nerve sparing; Medium, M-L, Large Prostatectomy is accomplished by two approaches 34 Details Details When surgeons converted this procedure to laparoscopic, they changed their clip-size preference from Medium and Large to M-L, as an all-purpose clip for cystic artery and cystic duct Donor Nephrectomies grab the headlines, but only 6,000 done annually. About 40,000 done for pathology Radical retropubic and perineal. Potentially a very bloody procedure There are still about 100,000 open procedures done, but these are mostly “incidental cholecystectomies,” performed in conjunction with another abdominal procedure Large portion done open, where automatic clip appliers are not as compelling. About 20 clips: M, M-L. As many as 80 clips can be used, M-L on lateral pedicals, Med: vas deferens, seminal vesicles Confidential - for internal use only Ligation System Clip Size Leading Use or Strong Potential Details Large— Cardiovascular and Vascular Various bypasses: femoral, other Large clips may be used for trunk remnants of large vessel such as saphenous vein, used as a graft Adrenal surgery places clips at advantage to ligate adrenal vein Large—General Gastrectomy Surgery (30,000) Adrenalectomy (15,000) Large— General, Colon & Rectal Colectomy (400,000) Large— Gynecology Gynecological Oncology Large-Thoracic Lungs Details Adrenal vein carries enzymes that can have negative effect on surgery Surgeons prefer Large vessels to take large are identified bundles of tissue and usually when cutting tied. Large across the clips are mesentery, a usually connective employed to membrane ligate large enclosing tissue bundles vessels and fat with inspecific vessels or bleeding Gyn Oncologists Gyn Oncology (1,000) perform procedures up to 100K are intestinal procedures per resection, year usually colon (30-50 clips) Lobectomy, Thoracic Aorta Wedge Resection 35 Details Significant challenge to security Many surgeons use sutures instead due their lower opinion of large clip security Confidential - for internal use only Ligation System X. APPENDIX Sales Qualification Forms Aesculap Evaluation Form 36 Confidential - for internal use only
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