Contego Medical today released preliminary data from a post-market registry study of its Paladin carotid post-dilation balloon that showed improved patient outcomes in individuals treated with the system, and no adverse events.
The device, which come with integrated embolic protection, is designed to provide embolic protection during post-dilation in carotid stent procedures, the Raleigh, N.C.-based company said.
“These preliminary results are consistent with previous findings and validate the Paladin System as a new meaningful technology in the carotid market. My experience in the post-market registry has been very positive. By incorporating this system into my practice, I can post-dilate the carotid stent and capture smaller embolic debris in a single step,” Dr. Ralf Langhoff of Berlin’s Saint Getrauden Hospital said in a press release.
The company reported a100% success rate for delivery and deployment of the system based on a post-market registry study of 50 patients, and a sub-study of 15 patients, with no complications reported up to 30-days post procedure.
“The positive results strengthen our belief in the Paladin System and the promise it holds to reduce the incidence of stroke in patients undergoing a carotid stenting procedure. Emboldened by the enthusiasm that continues to grow in the European clinical community, we are committed to ongoing clinical research to rigorously study this novel platform,” CEO Dr. Ravish Sachar said in prepared remarks.