Rex Medical Option Retrievable Vena Cava Filter Receives 510(k) Clearance and CE Mark Approval
Published: Jun 09, 2009
CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Rex Medical, L.P. today announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) along with CE Mark Approval for the Option™ Retrievable Vena Cava Filter in the prevention of recurrent Pulmonary Embolism (PE). The Option™ Filter has received marketing clearance for both permanent and temporary implantation indications and may be retrieved (removed from the patient) if the physician determines the patient is no longer at substantial risk for PE.
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™ is a self-centering, low profile, high performance vena cava filter. 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 long term device retrieval (U.S. indication of 175 days post implantation).
A prospective, multi-center study approved under an Investigational Device Exemption (IDE) by the FDA in the United States was successfully completed. The clinical data clearly established the safety and efficacy of the Option™ Filter in support of both a permanent and retrieval indication. Matthew S. Johnson, M.D., Professor of Radiology and Surgery, Indiana School of Medicine was the Lead Investigator. “The Option™ Filter provides excellent protection against pulmonary embolus, for as long as it is needed. I am thrilled that this unique and innovative filter will now be available to patients in the U.S.,” noted Dr. Johnson.
“We are pleased with the recent FDA Clearance for the Option™ Filter and are eager to introduce this technology into the marketplace along with our partner Angiotech Interventional, a global specialty pharmaceutical and medical device company. We remain committed to providing strong protection for the significant global patient population affected by venous thromboembolic disease,” commented Lindsay L. Carter, President of Rex Medical.
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.
Contact: Rex Medical, L.P. Lindsay Carter, 610-940-0665 x100