Contego Medical presented positive post-market registry data for the Paladin carotid post-dilation balloon with Integrated Embolic Protection Technology at the Leipzig Interventional Course (LINC) 2016, in Leipzig, Germany.
The presentation included compelling results from a diffusion-weighted MRI substudy that showed improved patient outcomes with the Paladin System.
Ravish Sachar, CEO and founder of Contego Medical, presented the preliminary results on symptomatic and asymptomatic carotid stenosis patients for 50 post-market registry patients and 15 diffusion-weighted MRI substudy patients. The post-market registry demonstrated a 100% success rate for delivery and deployment of the Paladin System, without the occurrence of device related complications over a 30-day follow-up period. Exhibiting excellent outcomes, the diffusion-weighted MRI substudy results compare favourably to published results for carotid stenting with single distal protection or proximal protection.
“These preliminary results are consistent with previous findings and validate the Paladin System as a new meaningful technology in the carotid market,” said Ralf Langhoff, director of Angiology, Saint Getrauden Hospital, Berlin, Germany. “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.”
The Paladin System provides vital embolic protection during the critical post-dilation step of a carotid stent procedure. By integrating a low-profile balloon and a 40-micron embolic filter into one catheter, the system simplifies the procedure and may improve safety.
“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,” said Sachar.