Shaping Surgical AF Ablation.
Cardioblate
CryoFlex
®
™
Surgical Ablation System
Unique malleability delivers argon-powered
cryoablation to create reproducible, transmural
lesions with a single probe.
Designed for
easy access.
Cardioblate® Surgical Ablation Systems have been
designed with maneuverability, placement and
visualization in mind. Uniquely malleable devices
put surgeons in control of creating the Maze III
lesion set with superior energy sources that give
greater confidence of lesion transmurality.
Cardioblate® CryoFlex™
Surgical Ablation Probe
Cardioblate® Surgical Ablation Portfolio
Cardioblate CryoFlex
®
™
Freeze deeper and faster for transmurality.
• T he Cardioblate® CryoFlex™ Argon-powered Cryoablation System puts surgeons in control
of Maze III surgical atrial fibrillation (AF) procedures
• U
niquely hand-malleable devices enhance maneuverability, placement and visualization
for easier ablation around pulmonary veins and upon atrial tissue
• Use CryoFlex probes on an arrested heart via sternotomy or right thoracotomy
• C
ompared to dry radiofrequency, the CryoFlex system provides added safety around
vulnerable tissue structures1,2
• Complete the entire Maze III lesion set with a single CryoFlex probe
Advantage Argon.
• Argon is the coldest commercially available surgical AF ablation energy source
• CryoFlex probes reach approximately -150º C in test freezes3
• In vitro tests show argon-powered cryoablation achieved deeper lesions than
those formed by nitrous oxide cryoablation4
Argon vs. Nitrous Oxide
Levels of Cell Death5,6,7,8
Argon Freezes to Lethal Cell Temperatures Deeper and Faster 4
Opposite-Side Tissue Temp. (ºC)
Bench test comparison between Cardioblate® CryoFlex™ probe and AtriCure Cryo 1™ probe
on 7 mm thick porcine tissue. Simultaneous freezes with both devices were performed
upon tissue, while recording temperatures on the tissue surface opposite of the probes.
Effective Cryoablation Achieves Necrotic Cell Temperatures
Through Targeted Tissue
Probe Tip
30
20
10
0
-10
-20
-30
Le
-40
-50
20
C e ll
thal
40
p
Te m
erat
Cross Section of Tissue
ure
60
80
100
120
Freeze Time(s)
Argon
Nitrous Oxide
Results may not be indicative
of clinical performance.
Necrosis [≈ -20˚C – -40˚C and colder] Cell destruction is immediate
and irreversible.
Apoptosis [≈ 0˚C – -20˚C ] Cells are damaged and may recover;
some cells destroyed
Hypothermia [≈ 32˚C – 0˚C ] Cells temporarily stop functioning
Distinctly
malleable.
Hand Malleable. Quickly shape and
re-shape by hand to facilitate placement.
Cardioblate® CryoFlex
™
Surgical Ablation Probes
Hand-malleable probes for every Maze III lesion.
•Corrugated probes are easily shaped and re-shaped
multiple times
•Use via sternotomy or right thoracotomy
•Intuitive one-piece attachment to the CryoFlex
generator console
•7cm, 10cm and 10-S probes to satisfy procedural
preference
•10-S probe optimizes malleability and increased
shape retention to provide greater tissue apposition
Adjustable Insulation Sheath. Varies the
length of the exposed probe tip and helps
protect non-targeted tissue.
Wide-opening Jaws. Aid clamp placement
around pulmonary veins and upon atrial tissue.
Single-trigger Mechanism.
Enables easy clamp and release.
Visual Confirmation. A unique viewing
window in the proximal jaw of the clamp
allows visualization of frost coming
completely through the tissue.
Cardioblate CryoFlex
®
™
2-in-1 Device. Remove
the probe from the clamp
to complete all lesions in
the Maze III procedure.
Cardioblate®
CryoFlex
™
Surgical Ablation Clamp and Probe
Surgical Ablation
Console
The convenience of a clamp and probe in a single device.
•Quick and easy to set
up for use
•Combine the versatility of the CryoFlex 10cm probe
with the familiar and useful delivery of a clamp
•Parallel closing jaws feature a viewing window for
visualization of frost penetration through tissue
•Eject the probe to complete all lesions in the Maze III
surgical ablation procedure
•Use via sternotomy
•Intuitive one-touch
push-button controls
Product Ordering Information
CryoFlex™ Single-Use Probes
PRODUCT
CryoFlex™ Console Components
CATALOG CODE NO.
CryoFlex™ Probe, 7 cm
CryoFlex™ Probe, 10 cm
CryoFlex™ 10-S Probe, 10 cm
CryoFlex™ Clamp and Probe, 10 cm
60SF7
60SF2
60SF3
60CM1
1 each
1 each
1 each
1 each
USE
PRODUCT
Single
Single
Single
Single
CryoFlex™ Control Panel
65CS1
Power Cord; CryoFlex™ Control Panel:*
• North American Standard
671PCNA
• European Standard
671PCE
• Italian Standard
671PCY
• United Kingdom Standard
671PCUK
™
CryoFlex Regulator (with pressure sensor cable):*
• North American Standard
67RAXNA
• European Standard
67RAXE
Gas Hose; CryoFlex™ System
67H08
Pressure Sensor Cable; CryoFlex™ System 67PS6
(replacement only)
CryoFlex™ Tank Carrier
65TC1
Note: The Cardioblate® CryoFlex™ Argon-Powered Surgical Ablation
System uses argon refrigerant for rapid ablation. Argon gas tanks are
obtained and refilled by local gas suppliers of the hospital’s choice.
For more information, call 877-526-7890 or 763-526-7890.
CATALOG CODE NO.
USE
1 each
Reusable
1 each
1 each
1 each
1 each
Reusable
Reusable
Reusable
Reusable
1 each
1 each
1 each
1 each
Reusable
Reusable
Reusable
Reusable
1 each
Reusable
* Order one per local standard.
References
1. FrostByte Chronic Dosing Study Summary Report. Data on file. MO61 Rev-0 August 2005. CryoCath Technologies Inc. Montreal, Canada.
2. Khairy P, Chauvet P, Lehmann J, et al. Lower incidence of thrombus formation with cryoenergy versus radio frequency catheter ablation. Circulation 2003;107:2045-50.
3. Medtronic Data on File.
4.Medtronic in vitro test data on file. Bench test comparison of the performance of Cardioblate CryoFlex argon-powered probe to AtriCure Cryo 1 nitrous oxide-powered probe on porcine tissue.
Results may not be indicative of clinical performance.
5.Baust JG, Gage AA. The molecular basis of cryosurgery. Institute of Biomedical Technology, State University of New York, Binghamton, and School of Medicine and Biomedical Sciences, State
University of New York at Buffalo, Buffalo, New York, NY, USA; pp.1187-91.
6. Gage A, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Journal of Society for Cryobiology 2009. Vol 59: 3; 229–43.
7.Aoyama H, Nakagawa H, Pitha J, et al. Comparison of cryothermia and radiofrequency current in safety and efficacy of catheter ablation within the canine coronary sinus close to the left
circumflex coronary artery. J Cardiovasc Electrophysiol 2005: Vol. 16;1218-26.
8. Gage AA, Baust J. Review Mechanisms of Tissue Injury in Cryosurgery. Cryobiology Vol. 37; pp. 171-86. State University of New York, Binghamtom, NY. ©1998 Academic Press.
The Cardioblate CryoFlex Surgical Ablation System
Indications for Use: is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the Cardioblate CryoFlex Clamp and Cardioblate CryoFlex Surgical
Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis. Contraindications: The Cardioblate CryoFlex Surgical Ablation Probe is not designed for use inside a beating heart.
Adverse Events or Complications: Potential adverse events with this device are similar to other cardiac surgery procedures and may include the following: bleeding; re-operation; extension of extracorporeal bypass; heart rhythm disturbances (atrial and/or
ventricular); effusion; pericarditis; cardiac tamponade; pleural effusion; mediastinitis; conduction disturbances (SA/AV node); acute ischemic myocardial event; thrombus formation; low cardiac output; stroke; renal, gastrointestinal or respiratory complications;
sepsis; adjacent structural damage; and death.
For a complete listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.
Cardioblate is a registered trademark of Medtronic, Inc. CryoFlex is a trademark of Medtronic, Inc. AtriCure Cryo 1 is a trademark of AtriCure, Inc.
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