US-based medical devices company Contego Medical has received the CE Mark approval for its new-generation carotid stent, Neuroguard IEP System.

Neuroguard IEP is a patented 3-in-1 carotid stent and post-dilation balloon system with Integrated Embolic Protection (IEP) technology.

The IEP platform is designed to simplify catheter-based procedures and improve patient outcomes. It combines embolic protection and treatment into one device.

Contego Medical CEO and founder Ravish Sachar said: “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.

“We anticipate launching the product in select countries as well initiating a post-marketing clinical study in the coming months.”

The Neuroguard IEP system is indicated for adult patients with clinically significant carotid artery stenosis requiring stenting.

The system includes a next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated micro-embolic filter with 40μm pores.

The closed cell stent in the Neuroguard IEP system features a unique asymmetric hourglass design to facilitate wall apposition in tortuous anatomy.

It is designed to achieve optimal strength, vessel coverage and flexibility, while the integrated filter allows to capture both macro- and micro-emboli during the entire procedure, said the company.

Contego first evaluated its Neuroguard IEP System in the PERFORMANCE I clinical trial, conducted in nine European sites, enrolling 67 patients with one year follow-up.

In the study, the procedures using the system showed overall success rate of 100% with a stroke and death rate of 0% at 30 days.

Contego Medical board chair Stacy Enxing Seng 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.”

In June 2020, the company has enrolled the first patient in the PERFORMANCE 2 carotid stenting trial, to evaluate the safety and effectiveness of its Neuroguard IEP system.