News | February 21, 2011

FDA Approves Endoprosthesis on Lower Profile Delivery System

February 21, 2011 – The U.S. Food and Drug Administration has approved an endoprosthesis device for use on a lower profile delivery system. The Gore Viabahn Endoprosthesis with Heparin Bioactive Surface, from W.L. Gore and Associates, is designed to percutaneously treat peripheral artery disease by relining the native vessel.

The next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices and is delivered over a 0.0180-inch or 0.014-inch guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the superficial femoral artery (SFA) and iliac artery.

“While most technology has stagnated over the past several years, W. L. Gore continues to optimize the Gore Viabahn Endoprosthesis which allows physicians to broaden the potential patient population that we can treat,” said Gary Ansel, M.D., interventional cardiologist at Riverside Methodist Hospital, Columbus, Ohio.

The endoprosthesis with Heparin Bioactive Surface is the only stent-graft approved for use in the SFA and iliac artery. The new device is available with a 120-cm long delivery catheter and incorporates the Carmeda BioActive Surface (CBAS), which utilizes end-point immobilization of derivatized heparin to the endoprosthesis luminal surface. This surface preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed.

The Gore Viabahn Endoprosthesis was introduced in the United States in 2001. The Endoprosthesis with Heparin Bioactive Surface was approved for use in the United States in 2007. The stent-graft is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The device’s flexibility enables it to better traverse tortuous areas of the SFA and iliac artery, allowing it to conform to these arteries and withstand complex mechanical motion.

For more information: www.goremedical.com

Related Content

The U.S. Food and Drug Administration (FDA) recently granted an additional indication to Bard Peripheral Vascular's Covera Vascular Covered Stent for the treatment of a stenosis or blockage which has developed anywhere in the access circuit of patients on hemodialysis using an arteriovenous (AV) fistula.
Technology | Stents | April 03, 2019
April 3, 2019 — The U.S.

A comparison of stent strut thickness between the Orsiro stent, pictured, and the market-leading stents on the U.S. and European markets. Vendors have been working toward reducing strut thickness to help improve overall clinical outcomes. Orsiro is now the smallest strut stent available on the market. 

Feature | Stents | February 22, 2019 | Dave Fornell, Editor
February 22, 2019 — The U.S.
The Medtronic Resolute Integrity drug-eluting stent is among the top three stents on the U.S. market. Outcomes for these stents are very similar, so the stents have largely become a commodity product purchased on price rather than clinical data. Stent advances and new stent technologies.

The Medtronic Resolute Integrity drug-eluting stent (DES) is among the top three stents on the U.S. market. Outcomes for these stents are very similar, so the stents have largely become a commodity product purchased on price rather than clinical data.

Feature | Stents | January 29, 2019 | Dave Fornell, Editor
There was a lot of hype and high hopes pinned on bioresorbable stent technologies as the way of the future two years
The Indian-made SMT SuperFlex stent. SMT has been developing stents and other interventional products designed to be a more affordable, home-grown option for the growing Indian market.

The Indian-made SMT SuperFlex stent. SMT has been developing stents and other interventional products designed to be a more affordable, home-grown option for the growing Indian market.

News | Stents | January 22, 2019
The rise cardiovascular disease has been instrumental in fueling the coronary stent market share in the past few year
The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent. #TCT2018

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent.

News | Stents | October 04, 2018
October 4, 2018 – Investigators unveiled clinical data from the independent BIONYX and SORT OUT IX all-comers trials
FDA Approves Biotronik's PK Papyrus Stent for Coronary Perforations
Technology | Stents | September 27, 2018
September 27, 2018 — Biotronik recently announced U.S.
Videos | Stents | September 11, 2018
This is an animation showing how the dedicated bifurcation stent developed by Advanced Bifurcation Systems (ABS) is d
Elixir Medical Corporation Unveils Transformational DynamX Stent Featuring Adaptive Segments that Uncage the Stented Artery
News | Stents | January 25, 2018
January 25, 2018 – Elixir Medical Corporation, a leader in the development of breakthrough adaptive remodeling techno
The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents | November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents | November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
Overlay Init