RALEIGH, North Carolina, July 20, 2016 /PRNewswire/ -- Contego Medical, LLC announced today that it has completed enrollment in the Paladin® Carotid PostDilation Balloon System Registry in Europe. The registry involved 5 centers with 100 total patients, and represents the first prospective clinical evaluation of a new class of device that provides Integrated Embolic Protection™ (IEP) technology for interventional treatment of carotid stenosis.
The Paladin System offers improved outcomes by reducing the risk of embolization during post-dilation, when the patient has the highest risk of embolic events that can lead to stroke. The single-step system integrates a post-dilation balloon proximally and a small-particle embolic protection filter at the distal catheter tip. The intuitive and versatile system enhances a physician's ability to safely treat carotid stenosis.
"As Principle Investigator of this study, it is gratifying to see a new type of technology available that addresses safer treatment of patients with carotid artery disease," said Professor Thomas Zeller, Head of Angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany. "I am encouraged by our results with Paladin and look forward to using devices with IEP technology for other cardiovascular applications."
"This is a very important study in demonstrating the importance of small particle embolization capture for carotid stenting," said Dr. Ralf Langhoff, Director of Angiology, Saint Getrauden Hospital, Berlin, Germany. "Procedural success rate has been high and interim results of 30-day MRI scans are very promising. I'm pleased to be part of this registry and the study of a new technology that can reduce embolization and stroke incidence for these procedures to almost zero without adding any sophisticated and time-consuming procedural steps. The technology is already embedded into our standard-of-care procedure technique for carotid artery stenting."
"In completing enrollment of the Paladin Registry, Contego Medical has taken another critical step toward impacting patient safety in carotid stenting," said Dr. Ravish Sachar, CEO and Founder of Contego Medical. "These registry data will continue to provide further clinical and scientific evidence in demonstrating the value of the Paladin System in simplifying and improving embolic protection."
About Contego Medical, LLC
Contego Medical (Raleigh, NC), 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 product performance. Physicians Ravish Sachar M.D. and Jay Yadav M.D., thought leaders and pioneers in the field of embolic protection, founded Contego in 2005. For more information, please visit www.contegomedical.com
The Paladin® Carotid Post-Dilation Balloon System is approved in Europe for post-dilation of a deployed self-expanding stent in the carotid artery. For additional information, warnings, precautions and contra-indications refer to the Paladin Instructions for Use. Paladin is not approved for use in the United States.
SOURCE Contego Medical, LLC