Neovasc has received CE mark designation for the use of its PeriPatch-BV bovine-derived biological tissue patches in surgical implantation procedures.
The CE marking confirms that PeriPatch-BV can 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.
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, and as components in implantable heart valves and other medical devices.
Neovasc’s viral inactivation study confirmed the performance of PeriPatch-BV on the critical parameter during PeriPatch fabrication.
Neovasc CEO Alexei Marko said the company has an established presence in Europe with their PeriPatch-EQ equine-derived tissue products, and look forward to expand their European footprint with the launch of PeriPatch-BV products derived from bovine pericardium, through exclusive agreement with LeMaitre Vascular for certain vascular applications, as well as through other distribution partners.