NexGen Medical Systems Announces FDA 510(k) Clearance of the XCOILTM Encapsulator
Monday, November 21st, 2011
MELBOURNE, FL – NexGen Medical Systems, Inc., a medical device company based in Melbourne FL, today announced FDA 510(k) clearance for its XCOILTM Encapsulator.
“We are very pleased that the XCOILTM Encapsulator can now be marketed together with the XCOILTM Retractor. The XCOILTM Retractor is indicated for removal of blood clots,” said John Kucharczyk, NexGen Medical Systems’ CEO. “There are more than 1,000,000 individuals in the United States that could potentially benefit from use of these XCOIL devices,” added Kucharczyk.
The indications for use of the XCOILTM Encapsulator are “percutaneous access to the peripheral vascular system…designed to assist in the placement and removal of devices.”
“The XCOILTM Encapsulator will be used in conjunction with the XCOILTM Retractor to remove blood clots in peripheral arteries and veins, including clots associated with deep vein thrombosis (DVT),” said Richard Latchaw, the Company’s medical director. “The XCOILTM Retractor deploys multiple thin coils behind and in front of blood clots. Once positioned, the coils are cinched together to firmly ensnare the clot. The XCOILTM System enables clots, such as often found in DVT, to be quickly and safely removed from the body,” added Latchaw.
The XCOILTM Retractor previously received FDA 510(k) clearance for “…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…”
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