Crux Biomedical commences enrollment in Retrieve 2 pivotal U.S. IDE trial of new Vena Cava Filter

Crux Biomedical®Inc. announced today that it has successfully enrolled the first patient in its Retrieve 2 pivotal U.S. IDE trial. The trial will evaluate the safety and efficacy of Crux's new Vena Cava Filter (VCF). The Crux VCF is a retrievable, implantable filter which is designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). It is the first VCF to be developed that is bidirectional and thus permits insertion or retrieval from either the femoral or jugular veins.

The implant was performed by Jon Hupp, a vascular surgeon at Anne Arundel Medical Center, located in Annapolis, Maryland. "Current retrievable filters either require short term removal or seem to have an unacceptable frequency of migration or fracture issues. Hopefully, the Crux filter will improve on this situation. There are a large number of patients who could benefit from such a device," Dr. Hupp explained. Crux's Retrieve 2 study is being conducted at 18 sites in the United States.

Vena cava filters were originally designed as a permanent implant only. Subsequent design improvements have provided physicians with the option to retrieve the filter once a patient is no longer at risk of a PE. Presently in the United States, over 50% of vena cava filters implanted are designed for retrieval at a later date. However, currently cleared vena cava filters are associated with a variety of complications. These complications present challenges to the physician when attempting to retrieve the device. The Crux VCF design will prevent filter tilt and associated challenges in retrieval. "Physicians are very enthusiastic with our bidirectional design and the additional choices that it will provide in delivery and retrieval of the implant," stated Mel Schatz, CEO of Crux Biomedical.

Vena cava filters were first introduced in the 1960s and have become an important tool to reduce the occurrence of a PE. There are an estimated 200,000 deaths per year attributed to PE in the United States. The CDC and the American Public Health Association have indicated that the deaths due to PE exceed the combined mortality per annum in the U.S. attributed to breast cancer, AIDS and traffic accidents.