Contego Medical said today it won CE Mark approval in the European Union for its Vanguard IEP periperhal balloon angioplasty system and launched the device in the region.
The newly cleared Vanguard IEP system incorporates a peripheral angioplasty balloon and distal embolic filter on a single catheter, the Raleigh, N.C.-based company said. The system has an over-the-wire design with a sheathless integrated 150-micron pore filter distal for the angioplasty balloon.
“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,” Vanguard study principal investigator Thomas Zeller of Bad Krozingen, Germany’s Universitaets-Herzzentrum Freiburg said in a prepared statement.
Contego claims that the Vanguard IEP is the 1st filter to feature in-vivo adjustability for varying vessel sizes. The company said it has already established a distribution network to sell the device in the region.
“The CE Mark for the Vanguard IEP System expands our product portfolio of novel devices designed to provide enhanced safety during peripheral vascular procedures. We are eager to positively impact this growing patient population, with an estimated 200 million people affected by peripheral arterial disease worldwide,” Contego Medical CEO Dr. Ravish Sachar said in a press release.
In January, Contego Medical released preliminary data from a post-market registry study of its Paladin carotid post-dilation balloon that showed improved patient outcomes in individuals treated with the system, and no adverse events.