News | January 21, 2009

Flexible Stenting Solutions Receives CE Mark for Self-Expanding Femoropopliteal Stent

January 22, 2009 - Flexible Stenting Solutions Inc. said this week it received CE Mark for its FlexStent Femoropopliteal Self Expanding Stent System.

Stent sizes include a complete matrix of 5, 6, 7 and 8 mm diameters with 30 through 150 mm lengths in a 6 French delivery system.

The FlexStent Femoropopliteal Self Expanding Stent System is indicated for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries. The company developed a novel, self-expanding stent technology to provide a wide range of vascular and non-vascular therapies. The fully connected flexible FlexStent has coupled technology with clinical needs by providing a stent with superior durability, flexibility, and radial stiffness, while providing uniform scaffolding. The key to the stent technology is the integration of helically wound struts with helical flexible coils. The key to the delivery system technology is simplicity, ease-of-use and placement, the company said.

In addition to the CE Mark, FSS plans to submit an investigational device exemption (IDE) application to the FDA. IDE approval will allow FSS to commence a U.S. clinical trial to collect clinical data for FDA premarket approval.

For more information: www.flexiblestent.com


Related Content

News | Stents

July 5, 2022 — A BIO-RESORT subgroup analysis of outcomes in small coronary vessels (<2,5mm) evaluated the efficacy and ...

Home July 05, 2022
Home
News | Stents

June 2, 2022 — According to the U.S. Food and Drug Administration (FDA), Atrium Medical Corporation is recalling the ...

Home June 02, 2022
Home
News | Stents

May 13, 2022 — Vascular diseases are public enemy number one: the leading killers worldwide, accounting for nearly a ...

Home May 13, 2022
Home
News | Stents

April 6, 2022 – Narrowed arteries can restrict blood flow to the heart. One treatment is inserting a stent — a small ...

Home April 06, 2022
Home
News | Stents

November 9, 2021 — Results from SUGAR trial, a randomized, controlled, multicenter trial conducted exclusively in ...

Home November 09, 2021
Home
News | Stents

June 30, 2021 — Abbott announced its Xience family of drug-eluting coronary stents received U.S. Food and Drug ...

Home June 30, 2021
Home
News | Stents

April, 14, 2021 – Elixir Medical recently announced the first patient was treated in the BIOADAPTOR randomized ...

Home April 14, 2021
Home
News | Stents

April 6, 2021 — Abbott today announced its Xience stent has received CE mark in Europe for shorter duration of dual anti ...

Home April 06, 2021
Home
News | Stents

December 21, 2020 – A proposed ASTM International standard will answer the need for a standardized test method that ...

Home December 21, 2020
Home
News | Stents

November 24, 2020 — One-year results off the PIONEER III study comparing the safety and efficacy of the Supreme HT ...

Home November 24, 2020
Home
Subscribe Now