Contego's Vanguard IEP Balloon Angioplasty System Receives CE Mark Approval

April 27, 2017—Contego Medical LLC announced that it has received European CE Mark approval for its peripheral balloon angioplasty system with integrated embolic protection (IEP). The Vanguard IEP system protects the lower limbs during angioplasty without the need for additional devices or exchanges. The device will be launched in Europe through Contego's established distribution network to endovascular specialists performing lower limb angioplasty procedures.

According to the company, Contego’s IEP technology incorporates a peripheral angioplasty balloon and distal embolic filter on the same catheter. The device has an over-the-wire design with a sheathless, integrated, 150-μm-pore filter that is distal to the angioplasty balloon. The filter features in vivo adjustability to suit varying vessel sizes and maximize capture efficiency.

Prof. Thomas Zeller, MD, Director of the Department of Angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany, serves as Principal Investigator of the upcoming Vanguard clinical study. In Contego's announcement, Prof. Zeller commented, “The Vanguard IEP system is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease. This device will be of particular importance to patients at high risk for distal embolization, such as those with acute limb ischemia or chronic total occlusions, as well as those at higher risk should embolization occur, such as patients with critical limb ischemia and diabetes mellitus.”