Possis Medical, Inc. has received clearance from the FDA to market its AngioJet Xpeedior catheter to remove blood clots (thrombus) from upper- and lower-extremity peripheral veins. Used with the company’s AngioJet System, Xpeedior is the only device cleared for thrombectomy in peripheral veins.
Approved for removal of thrombus 3 mm and larger in diameter, the Xpeedior catheter is also is cleared for general peripheral vascular use with Possis' Power Pulse Delivery, a procedure that enables the physician to spray smaller doses of clot-dissolving medicine directly into the thrombus and then quickly remove the softened clot material.
Possis says that while venous blood clots have been customarily treated with drugs to prevent the clot from growing larger, little is done to address the underlying problem: venous blockage that causes permanent vein damage called post-thrombotic syndrome. Painful and debilitating for its hundreds of thousands of victims, the condition is a costly one, too — creating a national burden of billions, according to one estimate.
"A rapid, definitive interventional treatment for venous thrombosis has been lacking,” said Dr. Anthony C. Venbrux, of the George Washington University Medical Center in Washington, D.C., and lead physician for the team that treated Vice President Dick Cheney last year. “I have used the AngioJet System to successfully treat many patients with arterial and venous blockages due to clot. The new FDA clearance opens the door to wider acceptance by the medical community. Future studies should evaluate the use of AngioJet therapy to quickly restore venous circulation and potentially reduce the occurrence of post-thrombotic syndrome. This is very encouraging news for young patients, as well as for an aging population with a higher incidence of circulatory disease," Dr. Venbrux said.
According to Possis, use of the AngioJet System for venous thrombectomy is currently identified as a reimbursable procedure for both physicians and hospitals. The company estimates that the realizable market opportunity for venous thrombectomy now exceeds $85 million, and will grow to more than $100 million by 2010.