GORE® TIGRIS® Vascular Stent Gains FDA Approval for Treatment of Peripheral Artery Disease

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W.
L. Gore & Associates, Inc. (Gore) today announced the U.S. Food
and Drug Administration (FDA) approval of the GORE® TIGRIS® Vascular
Stent, a dual-component stent with a unique fluoropolymer / nitinol
design. The GORE TIGRIS device, which gained CE Mark approval in 2011,
is a third generation, self-expanding stent. The device was designed
explicitly to improve anatomical conformability with the natural
movement of the knee when treating Peripheral Artery Disease (PAD).
The newly-approved GORE TIGRIS Vascular Stent uses a dual component
structure, made from a single-wire nitinol stent with flexible and
biocompatible fluoropolymer interconnections. The stent has been
designed to weather biomechanical forces (extension, compression,
flexion and torsion) without fractures, even in the most complex
anatomies, namely in the superficial femoral artery (SFA) and proximal
popliteal artery (PPA). In the U.S. clinical study that supported FDA
approval of the GORE TIGRIS Vascular Stent, the TIGRIS stent was found
to have zero fractures, while the control arm devices experienced a 27
percent fracture rate.
“The TIGRIS Vascular Stent has an innovative design that is very
different from any of the other nitinol stents that we currently use.
The extreme flexibility of this stent makes it well suited for the
superficial femoral artery and proximal popliteal artery, and the
delivery system is highly accurate. The precision offered by this
flexible, dual component device allows for easy insertion and
predictable clinical outcomes, even in challenging anatomy,” said John
R. Laird, MD, an interventional cardiologist in Davis, Calif.
The new device builds on the company’s long history and experience with
stenting, which spans more than two decades. The GORE TIGRIS Vascular
Stent also features Gore’s CBAS Heparin Surface, the proven, lasting
heparin bonding technology designed to resist thrombus formation, a
problem common in both bare metal and drug-eluting stents. End-point
covalent bonding keeps heparin anchored to the stent surface, while the
bioactive site remains free to interact with the blood to help prevent
clotting.
“At Gore, we pride ourselves in continuous evaluation of how our
technologies can benefit patients. To design an uncovered stent that
navigates and conforms to the complex anatomy of the artery, we
leveraged our long history with endovascular devices to develop the GORE
TIGRIS Vascular Stent. The addition of this device to our peripheral
interventional portfolio enables physicians to treat more diverse cases
with Gore’s best in class products,” said Ray Swinney, Business Unit
Leader for the Gore Peripheral Interventional Business Unit.
The evolution of peripheral stenting over the past decade has allowed
for broader adoption of endovascular therapy for treating PAD. When
physicians began placing stents in the SFA they were limited by first
generation stent designs that had longitudinal metal connections which
led to arterial stiffening, high fracture rates and poorer clinical
outcomes. Improvements in second generation devices introduced helical
interconnections to improve flexibility; however, their success in high
flexion vessels, like the distal SFA and PPA, was still limited.* The
introduction of third generation stents, including the GORE TIGRIS
Vascular Stent, allow for better adherence in some of the more intricate
vessels in the body.
PAD is prevalent in older populations, a rapidly growing demographic in
developed countries. In the U.S. alone, approximately 8 to 12 million
people suffer from some form of PAD. The disease can manifest in mild
symptoms such as chronic leg pain, and more serious complications
include poor wound healing, increased risk of stroke, and amputation.
Endovascular treatment, via angioplasty and stenting of a blocked
artery, is designed to treat PAD without the complications that can
accompany open surgery.
For more information on the GORE TIGRIS and the endovascular treatment
of PAD, please visit www.goremedical.com/tigrisna.
*Thaveau F, Méteyer V, LeJay A, Chakfé N. Latest generation of
conforming dual component stent. In: Greenhalgh RM, ed. Charing Cross
2016-Vascular & Endovascular Challenges Update. 2016 ed.
Fulham, London, United Kingdom: BIBA Publishing; 2016:423-428.
Products listed may not be available in all markets. GORE® and
TIGRIS® are trademarks of W. L. Gore & Associates. ©2016 W.
L. Gore & Associates, Inc. CBAS is a trademark of Carmeda AB, a wholly
owned subsidiary of W. L. Gore & Associates, Inc.
ABOUT W. L. GORE & ASSOCIATES
At Gore, we have provided creative therapeutic solutions to complex
medical problems for 40 years. During that time, 40 million innovative
Gore Medical Devices have been implanted, saving and improving the
quality of lives worldwide. Our extensive family of products includes
vascular grafts, endovascular and interventional devices, surgical
meshes for hernia and soft tissue reconstruction, staple line
reinforcement materials, and sutures for use in vascular, cardiac, and
general surgery. We are one of a select few companies to appear on all
of the U.S. “100 Best Companies to Work For” lists since the rankings
debuted in 1984.