VasoPrep Surgical announces De Novo Product Clearance by US Food and Drug Administration

Tuesday, January 06, 2015

VasoPrep Surgical announced that the Food and Drug Administration's (FDA) clearance of its surgical marking pen for sale in the U.S. market. The Dye Marker™, a Class II internal tissue marker indicated for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery, is used to demarcate selected sites and orientation of the vein graft prior to implantation. The device, cleared via the FDA's de novo pathway, is the first internal tissue marker cleared for use in the U.S. market.

"The FDA's clearance of the Dye Marker™ represents a significant milestone for VasoPrep and completes our first product line available for sale in the U.S.," said Cynthia Lander, Co-Founder and Chief Executive Officer of VasoPrep Surgical. "We hope that our products become important components of standard surgical vein harvest and provide surgeons with new tools to reduce surgical harvest-associated vein graft injury and spare bypass patients the clinical consequences that may be associated with vein graft failure."

Dr. Alan Dardik, Professor of Surgery at Yale School of Medicine and Chief of Vascular Surgery at VA Connecticut Healthcare Systems in West Haven, CT, said, "Recent data have shown that commonly used surgical skin markers can injure the vein graft. VasoPrep's vein marker and vein preparation kit products are real advances that give surgeons new options to reduce injury to vein grafts for bypass surgery."

 

Source : http://www.cnbc.com