Nfocus Neuromedical Inc. announced today that its CardioVasc Advantage Vascular Reconstruction Device has been granted CE Mark approval by the European Notified Body, G-Med.
"The technology of the Advantage VRD is an important demonstration of Nfocus design talent and teamwork," noted company Chairman, Eric P. Milledge. "The technical platform behind this device will pave the way for future Nfocus neurovascular products currently in development."
The CardioVasc Advantage(TM) Vascular Reconstruction Device has been cleared in Europe for the treatment of coronary artery perforations, aneurysms and saphenous vein graft lesions. Today, these critical pathologies are most frequently treated through less-invasive endovascular procedures. The Advantage VRD was designed to provide clinical benefits in these exacting procedures performed in small vessels.
"The Advantage VRD is a significant advance over previous small-vessel stent-grafts," said Martin S. Dieck, President and CEO.
"The Advantage VRD has greatly improved flexibility and a smaller crossing profile when compared to competitive devices. The European CE Mark approval gives Nfocus the ability to market this advanced system for the treatment of serious coronary vascular indications. The device is capable of attaining more distal placement with less vessel trauma due to its innovative design."