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Rex Medical Announces US FDA And CE Mark Approval For Option Retrievable Vena Cava Filter

Rex Medical, L.P. has announced the 510(k) clearance from the US 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 the 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. The company’s Option Filter 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 (US indication of 175 days post implantation). A prospective, multi-center study approved under an Investigational Device Exemption (IDE) by the FDA in the US 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 US,” 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.