European Postmarket Registry for Contego Medical's Paladin Carotid System Completes Enrollment

July 20, 2016—Contego Medical, LLC announced it has completed enrollment in the Paladin carotid postdilation balloon system registry in Europe. The registry involved five 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 trial is lead by Prof. Thomas Zeller, MD, who is Head of Angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany.

According to Contego Medical, the Paladin system improves outcomes by reducing the risk of embolization during postdilation, when the patient has the highest risk of embolic events that can lead to stroke. The system integrates a postdilation balloon proximally and a small-particle embolic protection filter at the distal catheter tip.

In the company’s announcement, Prof. Zeller commented, “As Principal 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. I am encouraged by our results with Paladin and look forward to using devices with IEP technology for other cardiovascular applications.” 

Ralf Langhoff, MD, who is Director of Angiology at St. Getrauden Hospital in Berlin, Germany, added, “This is a very important study in demonstrating the importance of small particle embolization capture for carotid stenting. Procedural success rate has been high and interim results of 30-day magnetic resonance imaging 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.”

The Paladin system is approved in Europe for postdilation of a deployed self-expanding stent in the carotid artery. The device is not approved for use in the United States, advised the company.