FDA clears Xtrak's thrombectomy catheter:
This article was originally published in Clinica
Executive Summary
The US FDA has given Xtrak Medical clearance to market its first product - a catheter system for removing blood clots from haemodialysis vascular access grafts. The XTD thrombectomy system is a low-profile, wall-contacting catheter that simultaneously pulverises and removes thrombus from the occluded grafts. A clinical study with the system demonstrated "excellent" technical success and three-month patency rates with very low complications, says the Salem, New Hampshire company. The XTD system is also already CE-marked for sale in Europe.