Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis.
The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said.
“We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a novel state-of-the-art carotid stent and provides uninterrupted micro-embolic protection during the most vulnerable stages of the procedure. I am very impressed with the performance of all aspects of the device,” Dr. Kedev said in a prepared statement.
In the trial, researchers aim to explore the safety and feasibility of the Neuroguard IEP system, which Contego said contains a novel, next-generation nitinol stent, pre-positioned post-dilation balloon and integrated microembolic filter.
“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. The Neuroguard IEP System represents Contego’s third innovation in our commitment to deliver endovascular devices designed to improve outcomes without increasing complexity,” CEO & founder Dr. Ravish Sachar said in a press release.
Last April, Contego said it won CE Mark approval in the European Union for its Vanguard IEP peripheral balloon angioplasty system and launched the device in the region.