Contego Medical has announced 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. The first cases with the device were performed by Ralf Langhoff (Sankt Gertrauden Krankenhaus, Berlin, Germany) with the first enrolled patient treated by Koen Deloose (AZ Sint Blasius, Dendermonde, Belgium). The Vanguard IEP system received CE mark in April 2017.
Contego says that the Vanguard IEP system represents the latest innovation of the company’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, following initial use.
The ENTRAP Study is a prospective, single-arm, multicentre study using the Vanguard IEP system and has been designed to evaluate acute safety and device performance. The study plans to enrol up to 130 subjects in centres throughout Belgium and Germany. Koen Deloose commented, “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.”
“Knowing that embolisation 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,” said Ravish Sachar, CEO and founder of Contego Medical.
“Peripheral artery disease is increasing in complexity, with more patients presenting with conditions such as acute limb ischaemia, chronic total occlusion and multi-vessel disease that leave them more susceptible to embolisation and its clinical consequences,” said Thomas Zeller (Unversitaets Herzzentrum, Freiburg, Bad-Krozingen, Germany), 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.”