MIAMI, Feb. 1 // -- Crux Biomedical, Inc., a privately held
medical device firm, announced at this week's International Symposium on Endovascular
Therapy that it has successfully completed the first set of patient trials for the Crux IVC filter. The Crux filter is used to prevent pulmonary embolism (PE), a potentially fatal condition arising from
blood clots forming in the legs, known as deep
vein thrombosis (DVT). Every year in the U.S., approximately 600,000 patients develop PE, and up to 120,000 die as a result. The revolutionary Crux filter is the first low-profile, self-centering, multiple-access, retrievable IVC filter.
According to Frank Arko, M.D., the endovascular surgeon of the University of Texas, Southwestern, who led the initial trials with Dr. Adrian Ebner at Hospital Privat Francais in Asuncion, Paraguay, "The device can be implanted or removed in less than five minutes."
"Tilting and retrieval are the biggest challenges with existing filters," Arko says. "Devices that are tilted in the cava can take hours to capture and retrieve, and some cannot be retrieved at all. The Crux filter addresses these issues because it self-centers automatically and can be easily retrieved from either jugular or femoral access." Thomas Fogarty, M.D., cardiovascular surgeon and founder of Crux Biomedical, states that "It's versatile, simple and easy to use."
"It's also worth noting that each retrieval was performed by a different physician," said Arko. "And in every case, it was the physician's first attempt to retrieve the device. Considering this, the fact that the team achieved 100% retrieval success was very encouraging. Everybody got it right on their first try," he says. "I was amazed at how easy these devices were to remove at five weeks post-implant."
"We feel we've arrived at a superior solution for the prevention of pulmonary embolism," states Mel Schatz, CEO of Crux Biomedical. "We're excited with the results of the initial trials, and we expect to file an IDE within the next few weeks, followed by a 510(k) submission in the latter part of the year."
Annual sales of IVC filters in the United States were estimated to be around $180 million in 2006 and are expected to reach $252 million by 2008, with a reasonable reimbursement coverage policy and payment determinations in place.
As they take the next steps in their clinical and regulatory pathways, the team at Crux Biomedical is confident that the superior design of their device will raise the standard for IVC filters. "With its lower profile, ability to self-center and ease of deployment and retrieval, the Crux IVC filter has several advantages over other IVC filters on the market today," says Schatz. "For the growing number of patients at risk for pulmonary embolism, we believe this is the solution patients need."
Crux Biomedical, headquartered in Portola Valley, Calif., was founded in late 2004 by Dr. Thomas Fogarty and Dr. Frank Arko. The company is developing a vascular device that promises to be a great improvement over existing modes of treatment. The device has been successfully tested in animal studies in 2006 and was recently implanted in humans. Crux is currently working with the FDA to design and implement large-scale human clinical trials. The clinical trials should begin in March.
