Neovasc out of Richmond, British Columbia won the European CE mark for its PeriPatch-BV bovine-derived biological tissue patches.
PeriPatch-BV products, which are derived from pericardium tissue, are used in a variety of general surgical and cardiovascular applications, including the XenoSure® product marketed by LeMaitre Vascular, Inc. and as components in implantable heart valves and other medical devices. CE marking confirms that PeriPatch-BV pericardial tissue products conform to the applicable European Directive and allows them to be implanted in patients in all member states of the EU, the European Economic Area and Switzerland. 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.
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 excellent performance of PeriPatch-BV on this critical parameter.