Vivasure Medical® (“Vivasure”) announced the successful enrollment of the first patient in the Frontier IV clinical study, a non-randomized multicenter international trial, designed to expand the indications of its proprietary PerQseal® large arteriotomy closure technology. The patient was enrolled by Dr. Peter Crean at the Blackrock Clinic, Dublin, Ireland.
Large arteriotomies (12F+) are vessel punctures created to facilitate endovascular procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), balloon valvuloplasty (BAV) and ventricular assist devices (VAD). PerQseal is the world’s first fully absorbable, patch-based large-bore percutaneous closure technology.
Dr. Christoph Naber of the department of cardiology and angiology, Contilia Heart and Vascular Centre, Essen, Germany, and TAVR principal investigator of Frontier IV said, “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.”
“We are very excited to begin the Frontier IV trial as the next phase in our commitment to build the clinical experience with PerQseal,” said Gerard Brett, co-founder and CEO of Vivasure. “A percutaneous approach has now become the gold standard for procedures such as TAVR and EVAR, driven by clinical outcomes data. As patient volumes increase, access site management and closure has become an increasingly important aspect of complication and cost reduction. The data from this trial will be used to support our goal of expanding the indication range of the PerQseal technology.”