Crux Biomedical, a company founded by Dr. Thomas Fogarty, the famous medical device inventor and noted winegrower, has received FDA approval for its Inferior Vena Cava Filter with bi-directional retrieval capability. The system was designed by Fogarty and the team to prevent known complications from existing devices like penetration of the caval wall, damage to nearby organs, and tilting of the filter that may allow emboli to pass.
From the press release:
“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.
By obstructing the blood flow through the lungs, pulmonary embolisms cause difficulty breathing, chest pain and palpitations. Each year in the U.S., approximately 600,000 patients develop pulmonary embolisms and an estimated 200,000 deaths occur. The primary means of prevention and therapy for pulmonary embolisms is systemic administration of anticoagulant agents. However, this treatment is contraindicated in many patients, including those with high bleeding risk, those undergoing complex surgeries and patients for whom anticoagulants were ineffective.
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, the main blood vessel returning blood from the lower part of the body to the heart, 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 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.”
A recently completed pivotal trial consisting of 125 patients at high risk for pulmonary embolisms, called the RETRIEVE Clinical Study, was 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.
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.
Flashbacks: Fogarty’s Crux Vena Cava Filter Proving Itself a Safer, Easier Option for Recurrent Pulmonary Embolisms; Crux Biomedical Inferior Vena Cava Filter with Bi-Directional Retrieval Receives CE Mark
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