Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection.
Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January.
A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said.
“We are thrilled to have achieved this milestone for the first of several devices Contego Medical intends to bring to the U.S. market,” founder & CEO Dr. Ravish Sachar said in prepared remarks. “The Paladin system utilizes our patented integrated embolic protection technology, aimed at providing superior performance while improving the safety profile of existing cardiovascular procedures. With the strength of our clinical data and the unique promise of our IEP technology, we look forward to positively impacting patient care and outcomes.”
“Minor stroke continues to be the Achilles heel of carotid artery stenting, which occurs as a result of micro-embolization during the procedure,” added Dr. William Gray of Wynnewood, Pa.’s Main Line Health. “The Paladin system offers optimized micro-embolic protection during the most vulnerable aspects of the procedure, without additional device transitions or procedural time.”
Contego said the Paladin balloon is indicated for percutaneous transluminal angioplasty and post-dilation of self-expanding stents in carotid arteries of no more than 7.0mm diameter.