NexGen Medical Systems Announces FDA 510(k) Clearance of the XCOILTM Retractor for Removing Blood Clots in Patients with Deep Vein Thrombosis

Thursday, October 27th, 2011

MELBOURNE, FL – NexGen Medical Systems, Inc., a medical device company based in Melbourne FL, today announced FDA 510(k) clearance for an expanded indication of its XCOILTM Retractor Thrombectomy device.

“We are pleased that the XCOILTM Retractor can now be marketed for removal of blood clots in patients with deep vein thrombosis (DVT)”, said John Kucharczyk, NexGen Medical Systems’ CEO.” Of the over 450,000 individuals per year in the United States who suffer from DVT, approximately 250,000 could potentially benefit from treatment with the XCOIL device. The XCOILTM Retractor will facilitate removal of blood clots from clogged veins and arteries in the legs and arms. Another 150,000 patients with thrombosed hemodialysis grafts could also be treated,” added Kucharczyk.

The indications for use for the XCOILTM Retractor are “removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from dialysis grafts and arterio-venous fistulas”.

“The XCOILTM Retractor deploys multiple coils behind, throughout, and in front of blood clots,” said Richard Latchaw, the Company’s medical director. “Once positioned, the coils are then cinched together to firmly ensnare hard clot, as well as more bulky soft clot. The XCOILTM Retractor removes clots quickly and easily without thrombolytic drugs and without damaging venous valves,” added Latchaw.

“NexGen Medical Systems is developing medical device products to address unmet clinical needs in large patient populations, including deep vein thrombosis, peripheral arterial disease, and ischemic stroke,” Kucharczyk added. “The XCOILTM Retractor is another important step NexGen Medical Systems is taking to develop an integrated medical device product line for comprehensive management of blood clots.”

About NexGen Medical Systems

NexGen Medical Systems is a development stage company that designs medical devices that improve interventional procedures in patients with neurological and cardiovascular diseases. The Company has an office in Reno, NV, and a product development and manufacturing center in Melbourne, FL. NexGen Medical Systems is developing two medical device product lines that address urgent clinical needs in the interventional radiology and neurosurgery markets. The Company’s initial focus is on commercializing an integrated medical device product line for comprehensive management of blood clots.

Media Contact

For additional information about NexGen Medical Systems, please contact John Kucharczyk, CEO, tel. (775) 851-7337, fax (321) 728-0127, email: johnkucharczyk@nexgenmedsystem.com, web site: www.nexgenmedsystem.com