Healthcare Industry News: Angiotech Pharmaceuticals
News Release - May 10, 2007
Rex Medical Announces the Successful Retrieval of the Option(TM) Vena Cava Filter up to Day 225 in an International Clinical Study
CONSHOHOCKEN, Pa.--(HSMN NewsFeed)--Rex Medical, L.P., today announced the successful retrieval of the Option(TM) Vena Cava Filter in an international clinical study after implantation up to 225 days. A total of thirty patients were enrolled and 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 physician determines the patient is no longer at substantial risk for PE. In several patients evaluated for retrieval, the Option(TM) Filter was successfully retrieved 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. Dr. Ebner was also successful in performing a filter retrieval procedure at day 132 in a patient with a 13mm cava with the use of an EnSnare® Intravascular Retrieval Device (Angiotech Pharmaceuticals, Inc., Vancouver, BC Canada). The Option(TM) Filter now has been successfully retrieved ranging from day 14 to 225 via jugular access in this study. It is also important to note that the Option(TM) Filter was successfully retrieved via a femoral approach in one patient at day 203 without incident demonstrating the flexibility and versatility of this device. The force required to retrieve the filters was clinically acceptable in all cases. 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 our clinical experience to date, 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. Our recent retrieval procedures successfully performed and extending to 225 days post implant is very exciting. In addition, the ability to retrieve this filter from a femoral approach may provide the physician base with an alternative approach should patient issues exist that would preclude jugular access or crossing the heart. We are certainly pleased to have institutional access to this filter technology for the protection of our patient population," commented Dr. Ebner.
A prospective, multi-center clinical study approved under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration in the United States was initiated earlier this year 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. "We are very encouraged with the Option(TM) Vena Cava Filter IDE results received to date from institutions across the U.S. We look forward to the successful completion of this clinical study in the near future," commented Dr. Johnson.
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 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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