The Paladin carotid post-dilation balloon (Contego Medical) is to be commercialised in Europe. This device, according to a press release, is the first angioplasty balloon with Integrated Embolic Protection (IEP) technology for patients undergoing carotid stenting procedures.
The IEP platform is designed to simplify the procedure by streamlining embolic protection and treatment into one device. The design is also intended to improve patient outcomes.
“The Paladin System represents a significant development in embolic protection. In a single step I can post-dilate the carotid stent and capture smaller embolic debris using the 40-micron filter,” comments Alberto Cremonesi, director of Interventional Cardio-Angiology, Villa Maria Cecilia Hospital, Cotignola, Italy.
The Paladin system is designed to improve outcomes by reducing the risk of embolisation during post-dilation, when the patient has the highest risk of embolic events. The single-step system integrates a post-dilation balloon proximally and an embolic protection filter at the distal catheter tip. Prior to post-dilation, the physician deploys the adjustable 40-micron filter providing protection against both macro- and micro-embolic debris. The system is intended to be intuitive and versatile, and to enhance a physician’s ability to treat carotid stenosis.
“The European launch of the Paladin System marks a major milestone for Contego,” states Ravish Sachar, founder and chief executive officer of Contego Medical. “After receiving approval in 2015, the European post-market registry results have been very positive.”