Neovasc announced that it has received CE mark for the use of its PeriPatch-BV bovine-derived biological tissue. PeriPatch-BV products are used in a variety of general surgical and cardiovascular applications, including the XenoSure product marketed by LeMaitre Vascular, and as components in implantable heart valves and other medical devices.
As a prerequisite for obtaining the CE mark designation, Neovasc had to demonstrate the efficacy of its proprietary treatment processes used to inactivate viruses during PeriPatch fabrication. The viral inactivation study Neovasc conducted for the CE mark application confirmed the optimal performance of PeriPatch-BV on this critical parameter.
“Neovasc has an established presence in Europe with our PeriPatch-EQ equine-derived tissue products, and we look forward to expanding our European footprint with the launch of our PeriPatch-BV products derived from bovine pericardium, through our exclusive agreement with LeMaitre Vascular for certain vascular applications, as well as through other distribution partners,” commented Alexei Marko, CEO Neovasc.
“We believe that the approval of our CE mark application by European regulators validates the viral inactivation and other critical performance features of our bovine-derived pericardial tissue products, which should provide a streamlined regulatory pathway for our industry customers incorporating PeriPatch-BV tissue as components in their own products. Neovasc is currently the leading independent supplier of biological leaflet material to companies developing next-generation transcatheter heart valves, and we expect this approval to further enhance our leadership position,” Marko added.
The CE mark designation is expected to facilitate the approval of additional products in Europe that incorporate sterile and non-sterile PeriPatch-BV tissue as a sub-component, such as transcatheter heart valves.
About PeriPatch tissue
PeriPatch is flexible collagen tissue derived from specially treated bovine or equine pericardium. Neovasc’s proprietary process creates implantable, biocompatible tissue that retains the strength and physical characteristics of natural tissue.
Neovasc uses PeriPatch tissue in the manufacture of its surgical patch product line for cardiac and vascular reconstruction and repair and in general surgical procedures. It is also being incorporated into a wide range of implantable devices, such as minimally invasive heart valves that are under development by the company’s industry partners and customers. PeriPatch products have more than 20 years of positive implant history and are FDA cleared, CE marked and certified by the European Directorate for the Quality of Medicines and Health Care (EDQM).