Option inferior vena cava (IVC) filter is a medical device that is implanted into the body’s inferior vena cava to prevent pulmonary embolism.
Rex Medical anticipates that the filing for 510(k) approval with the FDA for the Option IVC filter will be completed in the near term. Rex Medical has filed for the CE Mark for the Option IVC filter and is awaiting approval from the European regulatory bodies. Pending regulatory approval, it is expected that the Option IVC Filter will be available for commercial sale in the US and in the EU by the end of 2008.
James McGuckin, co-founder of Rex Medical, said: “We believe that the Option IVC filter is a superior IVC filter and will significantly improve the clinical management of pulmonary emboli in patients. Clinical data from our international clinical study has shown that the Option IVC filter can be successfully retrieved in patients for longer than one year.”