Healthcare Industry News: vena cava filter
News Release - October 2, 2006
Rex Medical Announces the Successful Clinical Implantation of the Option(TM) Retrievable Vena Cava Filter in First Human Use
CONSHOHOCKEN, Pa.--(HSMN NewsFeed)--Rex Medical, L.P., today announced the successful implantation of the Option(TM) Retrievable vena cava filter in an international clinical study. Ten patients were successfully implanted with the Option(TM) Filter for the prevention of Deep Vein Thrombosis and Pulmonary Embolism using the Option(TM) Filter under the direction of Adrian A. Ebner, MD, Chief of Interventional Procedures and Cardiovascular Surgery, French Hospital, Asuncion, Paraguay. Under the study protocol, up to 30 patients will receive an Option(TM) Filter.There are over 2,000,000 new cases of Deep Vein Thrombosis (DVT) each year in the U.S. DVT is the leading cause of the more than 600,000 Pulmonary Embolism (PE) events recorded annually resulting in over 100,000 deaths. 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%.
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.
Commenting on his recent experience with the Option(TM) Filter, Dr. Ebner, MD, reported "we were extremely pleased to have early institutional access to this unique and promising vena cava filter technology for our patients. All 10 filters were deployed safely, accurately and without difficulty from both a femoral and jugular approach. We look forward to our continued participation in this exciting clinical study."
A clinical study in the United States is planned to begin later this year to collect data to support the filter as a permanent and retrievable device. 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.
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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