MANSFIELD, Mass.--(BUSINESS WIRE)-- Covidien (NYSE: COV - News), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved the EverFlex™ Self-Expanding Peripheral Stent System for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA). The EverFlex System, which has been approved for peripheral indication in international markets since 2006, is now available in the United States, including a 200 mm stent length.
The clinical data supporting the FDA approval of the EverFlex System for use in the peripheral vasculature was obtained through the DURABILITY II Investigational Device Exemption trial that enrolled patients at clinical sites within the U.S. and Europe. DURABILITY II is the first clinical study to evaluate lesions up to 18 cm and to specifically test the performance of a single long, up to 200 mm stent, in the SFA and PPA. Specifically, the study results show no major adverse events at 30 days and a low one-year stent fracture rate of 0.4 percent. Additionally, primary patency at one year was 67.7 percent when analyzed by simple proportions of patients patent; using Kaplan-Meier time-to-event analysis, it was 77.2 percent.
“DURABILITY II is a landmark trial intended to study the patency and fracture resistance of placing a single nitinol stent in the superficial femoral artery. It provided the clinical evidence necessary to demonstrate that you can successfully treat long, complex lesions in the SFA with the EverFlex Self-Expanding Peripheral Stent,” said Dr. Krishna Rocha-Singh, MD, Director, Prairie Vascular Institute, Springfield, Illinois, and co-national principal investigator of DURABILITY II.
Until now, physicians often addressed longer lesions by overlapping multiple stents. Overlapping stents have a higher propensity to fracture, thereby increasing the potential for restenosis to occur. Being able to place one long stent, versus multiple shorter stents, may lead to better long term clinical performance.
“The DURABILITY II findings demonstrate the safety and effectiveness of our EverFlex stents,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “Having an indication in the SFA - as well as a 200 mm stent - is imperative when treating Peripheral Arterial Disease (P.A.D.).”
One of the most common vascular diseases, P.A.D. occurs when leg arteries become narrowed or blocked by plaque. These blockages can result in severe pain, limited physical mobility and non-healing leg ulcers. According to the American Heart Association, approximately 10 million people in the U.S. suffer from P.A.D.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011 revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50196216&lang=en
MULTIMEDIA AVAILABLE:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50196216&lang=en
Contact:
Vascular Therapies
Rachel Bloom-Baglin, 508-261-6651
Vice President, Communications
rachel.bloombaglin@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com
