CE Mark Granted for Contego Medical’s Next-Gen Carotid Stent

Contego Medical Inc., a developer of cardiovascular devices, has received CE Mark approval for the Neuroguard IEP three-in-one Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System).
 
The patented Neuroguard IEP System contains a novel, next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40 μm pores. The closed cell stent is designed to achieve optimal performance across radial strength, vessel coverage and flexibility, additionally featuring a unique 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 micro-emboli during the entire procedure.  The Neuroguard IEP System is indicated for adult patients with clinically significant carotid artery stenosis requiring stenting.

“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,” said Ravish Sachar, M.D., CEO and founder of Contego Medical. “We anticipate launching the product in select countries as well initiating a post-marketing clinical study in the coming months.”
 
The Neuroguard IEP System was first evaluated in the PERFORMANCE I clinical trial. The study was conducted in nine European sites and included 67 patients with one year follow-up. The overall success rate was 100 percent with a stroke and death rate of 0 percent at 30 days.¹
 
Stacy Enxing Seng, Venture Partner, Lightstone Ventures, and Contego Medical board chair, said, “Receipt of CE Mark approval for the Neuroguard IEP System is a significant achievement for the Contego Medical team and represents a multi-year investment in innovative product development and high-quality clinical research. I believe that the Neuroguard IEP System has the performance and ease of use to become the standard of care in the treatment of carotid artery disease.”
 
Contego Medical Inc. is a medical device company dedicated to the development of 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.
 
In the United States, the Neuroguard IEP System is an investigational device, limited by United States law to investigational use.

Reference 
¹ LINC 2020