RALEIGH, N.C., Sept. 12, 2017 /PRNewswire/ -- Contego Medical, LLC announced today the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection in patients receiving peripheral angioplasty. First cases with the device were performed by Ralf Langhoff, M.D. at Sankt Gertrauden Krankenhaus in Berlin, Germany, with the first enrolled patient treated by Koen Deloose, M.D. at AZ Sint Blasius in Dendermonde, Belgium. The Vanguard IEP System received CE mark in April 2017.
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 device is very straightforward and intuitive which makes handling simple and easy - no extra working steps at all," said Ralf Langhoff, M.D. following initial use.
The ENTRAP Study is a prospective, single-arm, multicenter study using the Vanguard IEP System and has been designed to evaluate acute safety and device performance. The study plans to enroll up to 130 subjects in centers throughout Belgium and Germany. Koen Deloose, M.D. commented, "Visual debris was noted in the first cases I performed with the Vanguard IEP System, underscoring the need for embolic protection during complex femoro-popliteal angioplasty."
"The ENTRAP Study represents Contego's latest chapter in our ongoing commitment to provide added protection in endovascular procedures," said Ravish Sachar, M.D., CEO and Founder of Contego Medical. "Knowing that embolization occurs with every intervention, we are excited to capture data on the safety impact of the Vanguard IEP System on the large and growing patient population undergoing peripheral angioplasty."
"Peripheral artery disease is increasing in complexity, with more patients presenting with conditions such as acute limb ischemia, chronic total occlusion and multi-vessel disease that leave them more susceptible to embolization and its clinical consequences," said Professor Thomas Zeller, Director of the Department of Angiology at Unversitaets Herzzentrum, Freiburg in Bad-Krozingen, Germany and Principal Investigator of the ENTRAP Study. "This study will collect important data on the safety benefits of incorporating integrated embolic protection using the Vanguard IEP System for these vulnerable patients."
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 in select European markets.
Vanguard IEP, IEP and Integrated Embolic Protection are trademarks of Contego Medical, LLC.