News | March 18, 2009

Flexible Stenting Solutions Files IDE With FDA for FlexStent Femoropopliteal Self-Expanding Stent

March 18, 2009 - Flexible Stenting Solutions Inc. (FSS) this week submitted an investigational device exemption (IDE) application to the FDA for its FlexStent Femoropopliteal SE Stent System for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries.

The company said this next generation femoropopliteal stent and delivery system may significantly improve patient care in the high growth peripheral vascular segment. While stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate stents, which are prone to strut fracture in the legs. The company said its fully connected flexible FlexStent is, flexible, highly durable and fatigue resistant and has superior radial stiffness, as well as excellent conformability to and mobility with the treated vessel.

FSS’s principle investigator for the U.S. clinical trial will be Dr. William Gray, the director of endovascular intervention at New York Columbia-Presbyterian Hospital in the Center for Interventional Vascular Therapy.

“The unique design developed for the FlexStent intends to address the important issue of stent fracture in the demanding femeropopliteal arterial segment, while maintaining radial force,” said Dr. Gray. “I am looking forward to beginning the clinical trial and excited to be part of this endeavor.”

For more information: www.flexiblestent.com

Related Content

News | Peripheral Artery Disease (PAD)| December 29, 2017
December 29, 2017 — iVascular announced the release of the new Oceanus 14 Pro percutaneous transluminal angioplasty (
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD)| September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

News | Peripheral Artery Disease (PAD)| August 02, 2017
Aug.
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System
News | Peripheral Artery Disease (PAD)| June 26, 2017
Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in...
Overlay Init