WARREN, N.J., April 3 /PRNewswire/ -- Cordis Endovascular, a division of Cordis Corporation, announced results from its PROOF post-marketing study, which monitored patients implanted with its permanent OPTEASE(R) Vena Cava Filter, were better than expected at 30-day follow-up, according to data presented at the 2006 Society for Interventional Radiology Annual Scientific Meeting in Toronto, Canada.
The PROOF study is a non-randomized, post marketing surveillance study involving 150 patients at high risk for pulmonary embolism (PE) who underwent filter implantation at 11 U.S. sites. The study was designed to monitor the performance of the filter through six months. At one-month, filter migration and filter-related symptomatic thrombosis were observed in one patient each (1.0 percent and 0.7 percent), compared to the expected rates(1) of 2.0 and 10.0 percent, respectively. At six-month follow-up, no new cases of filter migration or filter-related symptomatic thrombosis were observed.
“These findings are crucial because they confirm that the OPTEASE(R) Vena Cava Filter, when used as indicated, is a safe and effective treatment to help prevent recurrent pulmonary emboli.” said Sidney Cohen M.D., Ph.D., Cordis Corporation.
Key secondary endpoints of the PROOF study include rates of successful filter insertion, major adverse events including recurrent pulmonary embolism, and rates of filter migration, tilting or fracture at 6-months follow-up. All of these key secondary endpoints were within expected rates for the patient population enrolled in this study: There were no cases of filter thrombosis, thrombus formation, hematoma, access site infection, pulmonary embolism, air embolism, procedure related bleeding, renal failure, or vena cava wall perforation.
Vena cava filters are used to help prevent recurrent pulmonary emboli that occur when blood clots break free from larger clots in the peripheral circulation and travel to the lung, blocking blood flow. Each year, approximately 600,000 people experience a pulmonary embolism, resulting in an estimated 60,000 to 100,000 deaths. Patients at risk of pulmonary emboli are typically treated with anticoagulant therapy. Vena cava filters such as the OPTEASE(R) Vena Cava Filter, are used when anticoagulants can not be used, when anticoagulation has failed, or under certain other circumstances to prevent pulmonary embolism.
Cordis Endovascular’s OPTEASE(R) Vena Cava Filter design is based on the design of its market-leading TRAPEASE(R) Permanent Vena Cava Filter. In addition, the OPTEASE(R) Vena Cava Filter incorporates a caudal hook for percutaneous retrieval from the femoral vein, and an amended barb design combining migration resistance, while allowing for a controlled retrieval.
The OPTEASE(R) Vena Cava Filter’s self-centering design also optimizes clot capture efficiency and centers the retrieval hook for easy, consistent filter retrieval. Cordis Endovascular continues to utilize its 6 French delivery system, with the lowest profile on the market in the OPTEASE(R) Filter, providing patients with the least invasive vena cava filter available.
About Cordis Endovascular
Cordis Endovascular is a recognized leader in endovascular research and development. The company has the resources to make breakthrough treatments possible along with the reputation for delivering trusted, quality products and value that is expected by our customers.
Cordis Endovascular is a worldwide supplier of interventional and diagnostic medical products including nitinol and stainless steel stents, vena cava filters, balloon catheters and accessories. The company is committed to serving the cardiology, radiology and vascular surgery communities through the development of groundbreaking technologies for the treatment of peripheral vascular disease.
The company constantly seeks solutions to the human anatomy’s most challenging problems, such as carotid artery disease, aortic aneurysm, superficial femoral artery disease and venous thrombotic disease.
1. Expected rates were derived from the SCVIR quality improvement guidelines for permanent inferior vena cava filter placement (SCVIR 12: 137-141, 2001) and an objective performance criterion based on published historical data and expert clinical opinion.
Cordis Endovascular
CONTACT: Carol Goodrich, Cordis Endovascular, +1-908-412-7332 (p),+1-973-615-4057 (m), or Todd Ringler, Edelman Public Relations,+1-212-704-4572 (p), +1-781-599-7542 (m)
Web site: http://www.cordis.com/
