Contego Medical’s Neuroguard IEP Carotid System Approved in Europe

April 16, 2021—Contego Medical, Inc. announced receipt of CE Mark approval for the Neuroguard integrated embolic protection (IEP) three-in-one carotid stent and postdilation balloon system. The Neuroguard IEP system is indicated for adult patients with clinically significant carotid artery stenosis requiring stenting.

According to the company, the Neuroguard IEP system is composed of a next-generation nitinol stent, a prepositioned postdilation balloon, and an integrated microembolic filter with 40-μm pores. Additionally, the closed-cell stent features an asymmetric hourglass design that is flared at both ends to facilitate wall apposition in tortuous anatomy. The integrated filter is designed to capture both macro- and microemboli during the entire procedure.

The Neuroguard IEP system was first evaluated in the PERFORMANCE I clinical trial. The study was composed of 67 patients enrolled at nine European sites with 1-year follow-up. The overall success rate was 100%, with a stroke and death rate of 0% at 30 days, reported the company.

Ravish Sachar, MD, Chief Executive Officer and Founder of Contego Medical, stated in the company’s announcement, “CE Marking of the Neuroguard IEP system is an important milestone for Contego Medical and allows us to bring the remarkable safety and performance benefits of the Neuroguard stent to patients in Europe.”

Dr. Sachar further noted, “We anticipate launching the product in select countries as well as initiating a postmarketing clinical study in the coming months.”

In the United States, the Neuroguard IEP system is an investigational device, limited by law to investigational use, advised the company.