Data Presented at LINC for Contego Medical's Paladin System

January 26, 2016—Contego Medical announced the presentation of positive postmarket registry data for the Paladin carotid postdilation balloon with the company’s Integrated Embolic Protection technology at LINC 2016, the Leipzig Interventional Course, being held January 26–29 in Leipzig, Germany. The company stated that the presentation included compelling results from a diffusion-weighted magnetic resonance imaging (DW-MRI) substudy that showed improved patient outcomes with the Paladin system.

At LINC 2016, the preliminary results on symptomatic and asymptomatic carotid stenosis patients, including 50 postmarket registry patients and 15 DW-MRI substudy patients, were presented by Ravish Sachar, MD, who is Contego Medical’s CEO. Dr. Sachar and Jay Yadav, MD, founded Contego in 2005.

The Paladin system provides embolic protection during the postdilation step of a carotid stenting procedure. By integrating a low-profile balloon and a 40-µm embolic filter into one catheter, the system simplifies the procedure and may improve safety, stated the company. 

According to Contego Medical, the postmarket registry demonstrated a 100% success rate for delivery and deployment of the Paladin system, without the occurrence of device-related complications during a 30-day follow-up period. The DW-MRI substudy results compare favorably to published results for carotid stenting with single distal protection or proximal protection.

In Contego Medical’s press release, Ralf Langhoff, MD, Director of Angiology at Saint Getrauden Hospital in Berlin, Germany, commented, “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 postmarket registry has been very positive. By incorporating this system into my practice, I can postdilate the carotid stent and capture smaller embolic debris in a single step.”