Novel Carotid Stent Provides Integrated Embolic Protection

The Neuroguard IEP System has received to European Community CE mark of approval, following a study involving 67 patients with one year follow-up that showed an overall success rate of 100%, with a stroke and death rate of 0% at 30 days. It is an investigational device in the United States.

The system is comprised of a next-generation nitinol stent, a pre-positioned post-dilation balloon, and an integrated microembolic filter with 40 μm pores. The closed-cell stent design features an asymmetric hourglass shape that is flared at both ends, facilitating vessel wall apposition in tortuous anatomy and providing optimal performance, radial strength, vessel coverage, and flexibility. The integrated filter captures both macro- and micro-emboli during the entire procedure. The Neuroguard IEP also includes a 6F flexible delivery system designed to navigate carotid anatomy.

“The Neuroguard IEP System signals a new era in carotid artery stenting. By combining a novel stent, post-dilation balloon, and embolic filter onto the same catheter, we expect to dramatically impact this procedure by improving ease of use, reducing interventional time, and maximizing embolic protection,” said Ravish Sachar, MD, CEO and Founder of Contego Medical. “Our disruptive platform technology is aimed at providing the highest quality interventional solutions while providing seamless, anatomically-designed protection.”

During cardiovascular and endovascular procedures, debris from the treated vessels may embolize and lead to subsequent cerebral infarction, which may not be immediately clinically evident, and can take months or years for symptoms to manifest, such as devastating stroke, dementia, and cognitive decline. Embolic protection devices are designed to trap such emboli before they enter the brain.

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