Contego Medical Announces Positive Clinical Data for Paladin® System, the First Post-Dilation Balloon with Integrated Embolic Protection™ Technology
26 Jan, 2016, 11:01 GMT
Data presented at the Leipzig Interventional Course (LINC) demonstrates breakthrough treatment for Carotid Artery Disease
RALEIGH, North Carolina, Jan. 26, 2016 /PRNewswire/ -- Contego Medical, an innovator in developing next generation treatments for coronary and peripheral artery disease, today presented positive post-market registry data for the Paladin® Carotid Post-Dilation Balloon with Integrated Embolic Protection™ (IEP) Technology at LINC 2016, in Leipzig, Germany. The presentation included compelling results from a diffusion-weighted MRI (DW-MRI) sub-study that showed improved patient outcomes with the Paladin System.
Dr. 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 DW-MRI sub-study patients. The post-market registry demonstrated a 100 percent 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 DW-MRI sub-study results compare favorably 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," stated Dr. 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," commented Dr. Sachar. "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."
About Contego Medical, LLC
Contego Medical, a privately held medical device company, has developed a portfolio of novel products to address unmet needs in the cardiovascular and peripheral vascular space. Contego's innovative solutions integrate filter-based embolic protection and treatment into a single device. Their product portfolio is poised to transform cardiovascular and endovascular intervention by making existing procedures safer without increasing complexity or compromising performance. Physicians Ravish Sachar MD and Jay Yadav MD, thought leaders and proven entrepreneurs, founded Contego in 2005.
Learn more at www.contegomedical.com.
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SOURCE Contego Medical, LLC