Emboli, Thrombus Extraction Catheter Cleared by FDA

 

January 13, 2011

January 13, 2011 – A catheter that removes emboli and thrombi from vessels in the coronary and peripheral vasculature has received 510(k) clearance from the U.S. Food and Drug Administration. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corp. and distributed by Atrium Medical in the United States.

The catheter is an ultra-low profile manual aspiration system designed for the removal of fresh, soft emboli and thrombi in both coronary and peripheral vessels. It incorporates a removable stylet and has been designed with enhanced pushability, anti-kinking, trackability and crossability. Outside the United States, it is marketed as the Thrombuster II.

Thrombus aspiration uses the suction force generated from a syringe to pull soft, fresh thrombus from a vessel. Thrombus can form throughout the body, but manual thrombus aspiration is commonly used in patients who have heart attacks. The main cause of heart attacks is due to a plaque rupture in one of the major coronary arteries, which causes a blood clot to form, reducing blood flow and depriving the heart muscle downstream of oxygen-rich blood. Manual thrombus aspiration is one tool used by interventional cardiologists to remove the blood clot and restore critical blood flow to the heart muscle.

For more information: www.kaneka.co.jp, www.atriummed.com