Healthcare Industry News: Vena Cava Filter
News Release - January 18, 2007
Rex Medical Announces the Successful Clinical Retrieval of the Option(TM) Vena Cava Filter Up To Day 107 in an International Clinical StudyCONSHOHOCKEN, Pa.--(HSMN NewsFeed)--Rex Medical, L.P., today announced the successful retrieval of the Option(TM) Vena Cava Filter in an international clinical study. 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) under the direction of Adrian A. Ebner, MD, Chief of Interventional Procedures and Cardiovascular Surgery, French Hospital, Asuncion, Paraguay. 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. If left untreated, PE has a mortality rate in excess of 30%.
The Option(TM) Vena Cava Filter is designed to remain permanently in place, or to be removed from the patient if the doctor determines the patient is no longer at substantial risk for PE. In several patients evaluated for retrieval, the Option(TM) Filter was successfully retrieved most recently at times ranging from 84 to 107 days following filter implant by Anthony C. Venbrux, MD, Professor of Radiology and Surgery, Director, Cardiovascular & Interventional Radiology, George Washington University, Washington, DC. The Option(TM) Filter now has been successfully retrieved ranging from day 14 to 107 in this study. The force required to retrieve the filters was clinically acceptable in all cases. In one patient evaluated for filter retrieval at day 46, the decision was made to leave the filter in place as a pre-retrieval cavagram revealed a large blood clot trapped within the filter, suggesting the filter successfully protected against PE. Imaging conducted 38 days later demonstrated 95% clot resorption and the filter was then successfully retrieved. 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.
"Based upon my recent clinical experience, the Option(TM) Vena Cava Filter is safely and easily deployed and retrieved over varying implant time periods, which may be useful in patients requiring extended prophylaxis against PE, but ultimately may have their filter removed. This filter is precisely placed and demonstrates excellent stability in the inferior vena cava. From this positive experience, we welcome the initiation of the U.S. IDE clinical study in our institution shortly to gain additional clinical experience with the Option(TM) Filter in the United States," commented Dr. Venbrux.
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 is planned to begin early in February, 2007 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 will be the Lead Investigator. Extensive pre-clinical study data collected and analyzed in support of the clinical studies demonstrated excellent filter performance including effective self-centering, complete clot resorption at 90 days and no migration or adverse events associated with filter implantation and retrieval up to 90 days. All implanted filters were successfully retrieved.
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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