Raleigh, NC, (April 27, 1017) — Contego Medical, LLC announced today that it has received CE Marking of its Vanguard IEPä Peripheral Balloon Angioplasty System with Integrated Embolic Protection. The Company intends to launch the Vanguard IEP System in Europe to endovascular specialists performing lower limb angioplasty procedures.
The Vanguard IEP System represents the latest innovation of Contego’s Integrated Embolic Protection (IEP) technology, incorporating a peripheral angioplasty balloon and distal embolic filter on the same catheter. The system protects the lower limbs during angioplasty without the need for additional devices or exchanges. The Vanguard IEP System has an over-the-wire design with a sheathless integrated 150-micron pore filter distal to the angioplasty balloon. The Vanguard IEP System is the first filter to feature in-vivo adjustability to suit varying vessel sizes and maximize capture efficiency.
“The CE Mark for the Vanguard IEP System expands our product portfolio of novel devices designed to provide enhanced safety during peripheral vascular procedures,” said Ravish Sachar, M.D., CEO and Founder of Contego Medical. “We are eager to positively impact this growing patient population, with an estimated 200 million people affected by peripheral arterial disease worldwide.”
“The Vanguard IEP System is an important step toward enhancing safety for patients undergoing peripheral angioplasty for occlusive disease,” said Professor Thomas Zeller, Director of the Department of Angiology at Universitaets-Herzzentrum Freiburg in Bad Krozingen, Germany and Principal Investigator of the upcoming Vanguard clinical study. “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.”
Contego has established a premier distribution network throughout Europe to sell the Vanguard IEP System. Their first IEP device, the Paladin® Carotid Post-Dilation Balloon System was launched in Europe in 2016.
About Contego Medical
Contego Medical, LLC is a medical device company dedicated to the development of novel medical devices for cardiovascular and peripheral vascular procedures. The company’s Integrated Embolic Protection (IEP) platform, which combines embolic protection and treatment into one device, is designed to simplify catheter-based procedures and improve patient outcomes. Contego Medical is based in Raleigh, North Carolina, USA.
The Vanguard IEP System is CE marked and available for sale in select European countries.
Contact: David Stern, COO +1-404-435-8137
Vanguard IEP, Paladin and IEP are all trademarks of Contego Medical, LLC.