Healthcare Industry News: Vena Cava Filter
News Release - February 19, 2007
Rex Medical Announces the Successful Retrieval of the Option(TM) Vena Cava Filter from a Femoral Approach In VivoCONSHOHOCKEN, Pa.--(HSMN NewsFeed)--Rex Medical, L.P., today announced the successful retrieval of the Option(TM) Vena Cava Filter from a femoral approach in an Ovine model. The Option(TM) Filter was easily removed 60 days post implantation with no adverse events or abnormalities. The pull-out force required to retrieve the filter from a femoral access site was similar to the jugular access retrievals performed in an international clinical study being conducted under the direction of Adrian A. Ebner, MD, Chief of Interventional Procedures and Cardiovascular Surgery, French Hospital, Asuncion, Paraguay.
"Based upon our recent findings, this may be the prelude for dual (jugular and femoral) retrieval in humans. Confirmation of a dual retrieval option is planned for May, 2007 in our ongoing international clinical study," commented James F. McGuckin Jr, MD (Philadelphia Vascular Institute).
Twenty-nine patients enrolled to date have been successfully implanted with the Option(TM) Filter for the prevention of Pulmonary Embolism (PE) resulting from blood clots or "Deep Vein Thrombosis" (DVT). 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. The Option(TM) Filter now has been successfully retrieved ranging from day 14 to 107 in this study with several of the longer term retrievals (day 84 to 107) performed by Anthony C. Venbrux, MD, Professor of Radiology and Surgery, Director, Cardiovascular & Interventional Radiology, George Washington University, Washington, DC. Pre- and post-implant imaging (radiographs and cavagrams) demonstrated no filter migration or evidence of extravascular penetration along with wide vessel patency in all patients. No adverse events or abnormalities were observed.
A prospective, multi-center study clinical study approved under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration in the United States was initiated this month to collect data to support the filter as a permanent and retrievable device. Matthew S. Johnson, MD, Associate Professor of Radiology, Indiana School of Medicine and Chief, Vascular and Interventional Radiology, Clarian Health Partners is the Lead Investigator.
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 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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