Healthcare Industry News:  Vena Cava Filter 

Devices FDA

 News Release - November 6, 2006

New Low Profile Optional Vena Cava Filter Receives Conditional FDA Approval to Begin U.S. Clinical Trial

CONSHOHOCKEN, Pa.--(HSMN NewsFeed)--Rex Medical, L.P., today announced that it has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to begin a U.S. clinical trial for the Option(TM) Retrievable Vena Cava Filter in the prevention of recurrent Pulmonary Embolism (PE).

This prospective, multi-center study is designed to collect clinical data and establish the safety and efficacy of the Option(TM) Filter in support of both a permanent and retrieval indication. Ten U.S. sites have been selected to participate in this study. Matthew S. Johnson, MD, Associate Professor of Radiology, Indiana School of Medicine and Chief, Vascular and Interventional Radiology, Clarian Health Partners will be the Lead Investigator. "We are eager to begin enrolling patients in this exciting study who are at increased temporary or chronic risk for PE and require caval interruption. The unique and innovative Option(TM) Filter is designed to provide patient protection for both populations," noted Dr. Johnson.

The Option(TM) Filter is currently being evaluated in an international clinical study led by Adrian A. Ebner, MD, Chief of Interventional Procedures and Cardiovascular Surgery, French Hospital, Asuncion, Paraguay. All clinical procedures performed to date using the Option(TM) Filter are very encouraging and consistent with pre-clinical study findings.

Venous thromboembolic disease is a leading cause of morbidity and mortality in the United States, with PE being the most severe complication of the disease. PE occurs when thromboemboli (or "blood clots") become dislodged from the deep veins located in the legs and travel through the blood stream to the lungs. PE is the third leading acute cardiovascular cause of death in the U.S. resulting in as many as 240,000 deaths annually.

Option(TM) is designed as a self-centering, low profile, high performance Vena Cava Filter. The device may be retrieved after the risk of PE has passed or left permanently in place. This novel design incorporates proven nitinol construction in a 6Fr (O.D.) delivery system for precise delivery, increased stability, efficient clot capture and resorption, and device retrieval.

Rex Medical, L.P., based in Conshohocken, PA., is a privately held medical device company specializing in the development, manufacturing and marketing of minimally invasive medical devices targeted towards the cardiovascular, venous access, endosurgery and oncology markets. Rex Medical is ISO 13485 certified.


Source: Rex Medical

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