First Patient Enrolled in Vivasure’s Frontier IV Clinical Trial
October 13, 2017—Vivasure Medical announced that the first patient was enrolled in the Frontier IV clinical study, a nonrandomized, multicenter trial designed to expand the indications of the company’s proprietary PerQseal large arteriotomy closure technology. The patient was enrolled by Peter Crean, MD, of the Blackrock Clinic in Dublin, Ireland.
Large arteriotomies (> 12 F) are created to facilitate endovascular procedures, such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair, balloon valvuloplasty, and implantation of ventricular assist devices. According to Vivasure, PerQseal is the world’s first fully absorbable, patch-based, large-bore percutaneous closure technology.
The company describes PerQseal as a fully absorbable, intravascular patch used to seal large arteriotomies from the inside. The device’s synthetic polymer implant has a flexible, low-profile intravascular patch and a supporting scaffold. A portion of the scaffold extends through the arteriotomy and includes a locator to aid in maintaining the implant's position. Once deployed, the implant is rapidly endothelialized and fully absorbed.
In the company’s announcement, Christoph Naber, MD, Principal Investigator for the trial, commented, “Driven by clinical and economic outcomes data, percutaneous access site management has become an increasingly important aspect of TAVR procedures. I strongly believe PerQseal, which is designed specifically to address large arteriotomies, will help improve outcomes for these patients.” Dr. Naber is with the Department of Cardiology and Angiology at Contilia Heart and Vascular Centre in Essen, Germany.