Contego Medical Initiates ENTRAP Study of Vanguard IEP Peripheral Balloon Angioplasty System
October 2, 2017—Contego Medical, LLC recently announced the initiation of the ENTRAP study evaluating use of its Vanguard IEP peripheral balloon angioplasty system, with the company's integrated embolic protection (IEP) technology, in patients undergo peripheral angioplasty. The Vanguard IEP system received European CE Mark approval in April 2017.
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 patients in centers throughout Belgium and Germany.
The Vanguard IEP system, which incorporates a peripheral angioplasty balloon and distal embolic filter on the same catheter, protects the lower limbs during angioplasty without the need for additional devices or exchanges.
The first cases with the device were performed by Ralf Langhoff, MD, at Sankt Gertrauden Krankenhaus in Berlin, Germany. Commenting on the initial use, Dr. Langhoff stated in the company's announcement, “The device is very straightforward and intuitive, which makes handling simple and easy—no extra working steps at all.”
Koen Deloose, MD, who treated the first enrolled patient in the study at AZ Sint Blasius in Dendermonde, Belgium, added, “Visual debris was noted in the first cases I performed with the Vanguard IEP system, underscoring the need for embolic protection during complex femoropopliteal angioplasty.”
Professor Thomas Zeller, MD, who serves as Principal Investigator of the ENTRAP study, commented in the press release, “Peripheral artery disease is increasing in complexity, with more patients presenting with conditions such as acute limb ischemia, chronic total occlusion, and multivessel disease that leave them more susceptible to embolization and its clinical consequences. This study will collect important data on the safety benefits of incorporating integrated embolic protection using the Vanguard IEP system for these vulnerable patients.” Prof. Zeller is Director of the Department of Angiology at Universität Herzzentrum, Freiburg in Bad-Krozingen, Germany.