PALO ALTO, Calif., Feb. 12 /PRNewswire/ -- Nfocus Neuromedical, Inc. today announced that the company has received CE mark approval for the CardioVasc(TM) Stent-Graft and Delivery System. The CardioVasc(TM) Stent-Graft is a minimally invasive device for treating patients with Saphenous Vein Graft Lesions (SVGs) from a previous coronary bypass, Vessel Perforations and Coronary Artery Aneurysms. The CE mark allows Nfocus to begin marketing the CardioVasc(TM) Stent-Graft in the European Union, and indicates that the product complies with the appropriate quality and safety standards.
"We are pleased to be able to offer this valuable option to physicians in the European Union for treating diseased bypass grafts. This is an important first step in what we hope to be a series of regulatory approvals in the coming year," said Martin Dieck, President and CEO of Nfocus Neuromedical, Inc.
Saphenous Vein Graft Disease
Saphenous vein graft (SVG) disease has been a problem facing the cardiologist since the early days of coronary artery bypass graft (CABG) surgery. In CABG surgery, a segment of the patient's own leg vein (the "saphenous vein") may be removed and used to create an artificial conduit to bypass areas of blood flow blockage (also known as stenosis or plaque) that have built up in the patient's coronary artery. After CABG surgery, this SVG bypass itself may become blocked over time by the same type of disease that affected the patient's original coronary artery. The result is a need to reopen the diseased SVG vessel and restore flow. This second treatment again can be yet another surgery -- or alternatively, the SVG may be treated via angioplasty and stenting procedures using less-invasive endovascular (catheter) techniques. The CardioVasc(TM) Stent-Graft device is a permanent implant delivered via a less-invasive catheter procedure for patients that have a diseased SVG from a previous CABG surgery. The CardioVasc(TM) Stent-Graft is not approved in the United States.
Due to the large numbers of patients that have been helped by CABG surgery in past years, there is a large pool of patients with diseased SVG bypass vessels in need of this procedure.
For more information about Saphenous Vein Graft Disease see: http://www.americanheart.org/
About Nfocus Neuromedical, Inc.
Nfocus is a neurovascular development, manufacturing and marketing company focused on treating hemorrhagic stroke. Current and future product programs are aimed at rapid treatment of aneurysms and fistulas in the brain. Nfocus also has developed the CardioVasc(TM) Stent-graft for specific applications within the coronary artery disease market. Based in Palo Alto, California, Nfocus is privately held and venture capital backed. See http://www.nfocusneuro.com/ for further information.
Nfocus Neuromedical, Inc.
