A Medical Device Daily
Possis Medical (Minneapolis) reports that it has received approval from the FDA to market its AngioJet Spiroflex rapid exchange catheter to remove blood clots (thrombus) from coronary arteries. The catheter is specifically designed for blood clot removal (thrombectomy) in small vessels such as coronary arteries.
Possis says that the Spiroflex catheter allows physicians to quickly and effectively remove coronary thrombus by offering increased trackability inside the vessel, improved crossing in difficult anatomy, and fast and effective 360-degree thrombus removal. the catheter is now approved for sale in the U.S. and in overseas markets for both peripheral and coronary use.
Thrombus in coronary arteries and bypass grafts can cause lack of oxygen (ischemia) in the heart muscle and may lead to a damaging heart attack. More than 1 million patients suffer from heart attacks in the U.S. every year.
“The FDA’s approval of our Spiroflex catheter for coronary use is great news for patients suffering from potentially life-threatening coronary thrombus and for the physicians treating them,” said Robert Dutcher, president/CEO and chairman of Possis.
Possis manufacturers devices for the cardiovascular and vascular treatment markets.