First Patient Enrolled in Vena Cava Filter Trial
July 15, 2010 – The first patient has enrolled in the Retrieve 2 U.S. trial, which will evaluate the safety and efficacy of Crux Biomedical's new Vena Cava Filter (VCF). The Crux VCF is a retrievable, implantable filter that 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, M.D., a vascular surgeon at Anne Arundel Medical Center, in Annapolis, Md.
“Current retrievable filters either require short term removal or seem to have an unacceptable frequency of migration or fracture issues,” Hupp explained. “Hopefully, the Crux filter will improve on this situation. There are a large number of patients who could benefit from such a device.”
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, more than 50 percent 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. The Crux VCF design will prevent filter tilt and associated challenges in retrieval.
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