GORE® Embolic Filter: Summary of Results from
Gore EMBOLDEN Clinical Study
PERFORMANCE by design
US Indications
The GORE® Embolic Filter system is indicated for general use as a guidewire
and embolic protection system during angioplasty and stenting procedures in
carotid arteries with reference vessel diameters of 2.5 to 5.5mm. Refer to
Instructions for Use at goremedical.com for a complete description of all
contraindications, warnings, precautions and adverse events.
Objective of Gore EMBOLDEN Clinical Study
The objective of this study was to assess the safety and efficacy of
the GORE® Embolic Filter when used to provide embolic protection
during carotid artery stenting procedures in conjunction with any
FDA-approved carotid stent in patients at high risk for surgery.
Study Overview
Design
–– Prospective, multi-center, single arm study comparing the
GORE® Embolic Filter major adverse event (MAE) rate to a performance goal
(12%) derived from previous distal protection studies
Sample Size
–– 250 subjects enrolled at up to 40 US sites
Primary Endpoint
–– Proportion of subjects experiencing one or more MAE (death, stroke, MI)
through 30-day follow-up
Subject Population
–– Subjects diagnosed with carotid stenosis requiring revascularization and who
are at high risk for adverse events (AEs) from carotid endarterectomy (CEA)
Investigative Sites
Facility
Location
Facility
Location
Albany Medical Center
Albany, NY
Ochsner Clinic
New Orleans, LA
Baptist Cardiac & Vascular Institute
Miami, FL
Oregon Health and Sciences University
Portland, OR
Beth Israel Deaconess Medical Center
Boston, MA
Riverside Methodist Hospital
Columbus, OH
California Cardiovascular Consultants
Fremont, CA
Sanford Health Center
Sioux Falls, SD
Central Penn Cardiovascular Research
Harrisburg, PA
Southwest General Health Center
Middleburg Heights, OH
Cleveland Clinic Foundation
Cleveland, OH
Spokane Cardiology
Spokane, WA
Columbia University Medical Center
New York, NY
St. Elizabeth’s Medical Center
Boston, MA
Covenant Medical
Saginaw, MI
St. Francis Hospital
Roslyn, NY
El Camino Hospital
Mountain View, CA
St. John’s Mercy Medical Center
St. Louis, MO
Emory University Hospital
Atlanta, GA
St. Joseph Mercy Oakland
Pontiac, MI
Emory University Hospital Midtown
Atlanta, GA
St. Luke’s Medical Center
Milwaukee, WI
Hahnemann University Hospital
Philadelphia, PA
St. Luke’s Medical Center
Phoenix, AZ
Harper University Hospital
Detroit, MI
Swedish Heart and Vascular Institute
Seattle, WA
Heritage Valley Health System
Beaver, PA
The Christ Hospital
Cincinnati, OH
Hoag Memorial Hospital
Newport Beach, CA
University of Rochester Medical Center
Rochester, NY
Medical University of South Carolina
Charleston, SC
University of Wisconsin
Madison, WI
Mercy Hospital
Chicago, IL
Wake Forest University
Winston-Salem, NC
Millard Fillmore Gates Circle Hospital
Buffalo, NY
Washington Adventist Hospital
Tacoma Park, MD
North Central Heart Institute
Sioux Falls, SD
Top five enrollers noted in red
Product Design of GORE® Embolic Filter
• Nitinol diamond frame designed to
enhance wall apposition
• ePTFE filter
• 100 micron pores
• Hydrophilic heparin coating
• 5 and 7 mm diameter sizes
• 3.2 F delivery profile
• 4.8 F retrieval profile
Variable Landing Zone Requirements
per Instructions For Use
W. L. Gore &
Associates
GORE®
Embolic Filter
RX ACCUNET®
Device
EMBOSHIELD NAV6
Device
Frame Length (mm)
9
20.5
12.5
Frame and Filter Length (mm)
20
31.5
18.0
Filter Size Shown and Measured (Vessel Range) (mm)
7
7.5
7.2
(4.0 – 5.5)
(6.0 – 7.0)
(4.0 – 7.0)
Boston Scientific
Corporation
FILTERWIRE EZ
Device
Frame and Filter Length
ev3 Inc. / Covidien Cordis Corporation
SPIDERFX®
Device
Frame and
Filter Length
Frame and Filter Length
Frame
Length
Frame Length
Frame Length
Frame and Filter Length
Frame Length
Frame and Filter Length
Frame Length
Frame and Filter Length
Frame Length
Abbott Laboratories Abbott Laboratories
All photos at same magnification
Frame and Filter Length
Frame
Length
Relative Device Lengths
ANGIOGUARD® RX
Device
Medtronic, Inc. /
Invatec
FIBERNET®
Device
13.5
10.0
11.0
5.5
23.5
26.0
16.5
7.0
3.5 – 5.5
(3.5 – 5.5)
6.0
(4.5 – 6.0)
6.0
(5.5 – 6.5)
3.5 – 5.0
(3.5 – 5.0)
Lesion Interaction —
Tip Transitions / Crossing Profile
W. L. Gore &
Associates
Abbott Laboratories Abbott Laboratories
Boston Scientific
Corporation
ev3 Inc. / Covidien
Cordis Corporation
Medtronic, Inc. /
Invatec
GORE®
Embolic Filter
RX ACCUNET®
Device
EMBOSHIELD NAV6
Device
FILTERWIRE EZ
Device
SPIDERFX®
Device
ANGIOGUARD® RX
Device
FIBERNET®
Device
3.2 Fr
3.7 Fr
3.2 Fr
3.2 Fr
3.2 Fr
3.2 – 3.9 Fr
2.4 – 2.9 Fr
Labeled crossing profiles are shown for each device.
All photos at same magnification
Pore Size and Pattern
W. L. Gore &
Associates
Abbott Laboratories Abbott Laboratories
Boston Scientific
Corporation
ev3 Inc. / Covidien
Cordis Corporation
Medtronic, Inc. /
Invatec
GORE®
Embolic Filter
RX ACCUNET®
Device
EMBOSHIELD NAV6
Device
FILTERWIRE EZ
Device
SPIDERFX®
Device
ANGIOGUARD® RX
Device
FIBERNET®
Device
100 µm
150 µm max
120 µm
110 µm
70 – 200 µm
100 µm
N/A*
* Pore size is variable and is marketed by the size of the smallest particle caught, 40 µm.
All photos at same magnification
Enrollment Summary
Final Enrollment: 250 subjects
Number of Enrolling Sites: 35 of 37
Enrollment Period: January 2009 – July 2010
Data presented on 250 pivotal subjects
Subject Characteristics
N = 250
n
Age (years)
MEAN / %
(MIN, MAX)
75
(51, 92)
Symptomatic
37
15%
Age ≥ 80 years
92
37%
Symptomatic
16
7%
Asymptomatic
76
30%
153
61%
Male
Anatomic High Risk Factors
Restenosis after prior CEA
27%
Post radical head / neck
surgery or radiotherapy
10%
6%
Surgically inaccessible lesions
5%
Spinal immobility of the neck
Presence of tracheostomy stoma
2%
Laryngeal palsy / laryngectomy
2%
Contralateral laryngeal nerve damage
0%
0%
10%
20%
30%
% of Subjects (N = 250)
• Symptomatic status evenly
distributed among groups
• 47% of patients had at least
one Anatomic Risk Factor
40%
50%
Co-Morbid High-Risk Factors
Octogenarians
37%
Contralateral total occlusion of the ICA
10%
Two or more diseased coronary arteries
8%
LVEF < 30%
4%
NYHA Class III or IV
4%
COPD with FEV1 < 50%
3%
Uncontrolled diabetes
3%
Planned CABG or valve replacement
1%
Unstable angina with EKG changes
1%
MI within 30 days of procedure
1%
0%
• Symptomatic status evenly
distributed among groups
• 65% of patients with at least
one Co-Morbid Risk Factor
10%
20%
30%
% of Subjects (N = 250)
40%
50%
Procedural Descriptors
Procedure Time (minutes)
N = 250
Filter Dwell Time (minutes)
N = 241
Fluoroscopy Time (minutes)
N = 247
Hospital Stay (days)
N = 250
MEDIAN
(MIN, MAX)
45
(16, 153)
11
(4, 63)
16
(6, 65)
1
(1, 17)
Carotid Stents Implanted
10 subjects with 2+ stents
PROTÉGÉ® RX Device
7%
WALLSTENT® Device
5%
ACCULINK® Device
27%
PRECISE® Device
36%
XACT® Device
25%
% of Stents (N = 258)
Procedural Outcomes
Enrollment
Embolic Protection Deployment
Carotid Stent Deployment
Stenting Failure
(n = 2, 0.8%)
GORE® Embolic Filter
Used for
Embolic Protection
(n = 241, 96.4%)
Subjects
Enrolled
(N = 250)
Stenting Success
(n = 230, 95.6%)
98.0% Stenting
Success Overall
GORE® Embolic Filter
Not Used for
Embolic Protection
(n = 9, 3.6%)
Alternative EPD
Deployed
(n = 6, 2.4%)
Unable to Access / Pass Lesion –
Procedure Terminated
(n = 3, 1.2%)
Stenting Success
(n = 6, 2.4%)
30-Day Major Adverse Events
Death / Stroke / MI (n = 10)
4.0%
Death / Any Stroke (n = 9)
Death / Major Stroke (n = 3)
0.0%
3.6%
1.2%
2.0%
4.0%
% of Subjects (Intent to Treat Population)
The Death / Stroke / MI rate of 4.0%
was lower than the 12% performance
goal with a p-value of < 0.001
6.0%
30-Day Major Adverse Events
NUMBER OF SUBJECTS BY TYPE OF EVENT (NON-HIERARCHICAL)
All Enrolled Subjects (N = 250)
Death
Neurologic
Major Stroke
Ischemic, Ipsilateral
Minor Stroke
n (%)
2 (0.8%)
0 (0.0%)
1 (0.4%)
1 (0.4%)
6 (2.4%)
Ischemic, Ipsilateral
5 (2.0%)
Ischemic, Contralateral
1 (0.4%)
Myocardial Infarction
1 (0.4%)
Non Q-Wave
1 (0.4%)
Subjects with MAE
10 (4.0%)
Timing of Major Adverse Events
AGE
DESCRIPTION OF MAJOR ADVERSE EVENT
73
Stroke – ischemic, minor ipsilateral
82
Stroke – ischemic, minor ipsilateral
85
Stroke – ischemic, minor contralateral
83
Stroke – ischemic, minor ipsilateral
82
Stroke – ischemic, minor ipsilateral
83
Stroke – ischemic, minor ipsilateral
Day 2
63
Death – multi-system organ failure
Day 5
81
Non-Q wave MI
Day 20
60
Death – cardiac arrest
Day 25
78
Stroke – ischemic, major ipsilateral
ONSET
Day 0 (Post-Procedure)
Day 1
Death / Stroke / MI Rates by Subgroup
5.4%
Octogenarians (n = 92)
3.2%
Non-Octogenarians (n = 158)
3.4%
Anatomic Risk (n = 87)
4.3%
Co-Morbid Risk (n = 161)
Symptomatic (n = 37)
5.4%
Asymptomatic (n = 213)
3.8%
0.0%
2.0%
4.0%
% of Subjects in Subgroup (Intent to Treat Basis)
6.0%
Summary of Results
Met Study Primary Endpoint
–– Low death rate of 0.8%
–– Low stroke rate of 2.8%
–– Low MAE rate of 4.0%
Low MAE Rate of 5.4% for Octogenarians
Low MAE Rate of 5.4% for Symptomatic Subjects
High Technical Success Rate of 96.4%
Demonstrated compatibility with FDA approved
stents used in the trial
INDICATIONS FOR USE IN THE US: The GORE® Embolic Filter is indicated for use as a guidewire and embolic protection system to
contain and remove embolic material during angioplasty and stenting procedures in carotid arteries with diameters between 2.5 and
5.5 mm. INDICATIONS FOR USE UNDER CE MARK: The GORE® Embolic Filter is indicated for use as a guidewire and embolic protection
system to contain and remove embolic material (thrombus / debris) during angioplasty and stenting procedures in coronary arteries,
saphenous vein grafts, carotid arteries and peripheral arteries with reference diameters of 2.5 to 5.5 mm. Refer to Instructions for
Use at goremedical.com for a complete list of contraindications, warnings and precautions, and adverse events.
Products listed may not be available in all markets.
GORE®, PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates.
ANGIOGUARD® RX and PRECISE® are trademarks of Cordis Corporation.
FIBERNET® is a trademark of Medtronic, Inc.
FILTERWIRE EZ and WALLSTENT® are trademarks of Boston Scientific Corporation.
RX ACCUNET®, EMBOSHIELD NAV6, EMBOSHIELD® PRO, ACCULINK® and XACT® are trademarks
of Abbott Laboratories.
SPIDERFX® and PROTÉGÉ® RX are trademarks of ev3 Inc.
© 2011 W. L. Gore & Associates, Inc. AP4545-EN1 MAY 2011