Back in April we provided an update on Californian company Crux Biomedical’s clever Vena Cava Filter (VCF), which ended with the promise of news to come about its then forthcoming FDA approval. Now the company has announced receipt of FDA clearance for its novel device which features bi-directional retrieval.
Patients in whom anticoagulant treatment is contraindicated require alternate treatments to reduce the ongoing pulmonary embolism risk, including VCF – small filters that are placed in the inferior vena cava to prevent blood clots from reaching the lungs.
The FDA has recommended that physicians routinely remove VCF after the risk of pulmonary embolisms is reduced, to avoid long-term complications.
Crux says its VCF is the first and only design which facilitates bi-directional retrieval through either the femoral or jugular veins, a key consideration when access to one or the other vein is limited.
Crux points to a 125 subject trial of patients at high risk for pulmonary embolisms, called the RETRIEVE Clinical Study, performed at 22 sites in the U.S., Australia, New Zealand and Belgium. The study results were presented at the 2012 Society for Interventional Radiology (SIR) meeting and reported on Medlatest’s pages in April.
In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes. By the 6-month follow up of the study, no embolizations, migrations or fractures were observed.
“The Crux device demonstrated excellent deployment, retrieval and safety profile,” stated Robert R. Mendes, M.D., Principal Investigator of the study; Associate Professor of Surgery, University of North Carolina; and Chief of Vascular Surgery, Rex UNC Healthcare. “The clinical study evaluation has demonstrated the Crux VCF can be used safely for the prevention of recurrent pulmonary embolisms.”
“The Crux VCF System is the first major design innovation in vena cava filters in some 40 years,” stated Mel Schatz, CEO of Crux Biomedical. “We have been pleased with both the clinical outcomes in our pivotal clinical trial and the enthusiasm expressed by physicians using the Crux VCF.” The device’s novel helical shape was designed to self-center and to conform more closely to the shape of the vena cava, as well as to reduce bends and stress that can compromise filter integrity.
“Crux designed a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical. “Bi-directional deployment and retrieval are extremely helpful in situations where access to either the femoral or jugular vein is not possible. The Crux VCF with its innovative design and materials represents a paradigm shift in prevention of pulmonary embolisms in patients at risk.”
Source: Crux Biomedical Inc., Business Wire