Benzinga | May 25, 2021 01:48PM EDT

LeMaitre Highlights Received 5 CE Marks Under European Medica Devices Directive

LeMaitre (NASDAQ:LMAT), a provider of vascular devices, implants and services, today announced that it received CE marks under the European Medical Devices Directive (93/42/EC as amended by 2007/47/EC) for the following five products. Marks for the five products had previously lapsed due to a change in notified bodies.

Product Notified Body Expiration DateXenoSure Biologic Patches TUV SUD May 26, 2024AlboGraft Polyester Vascular Grafts TUV SUD May 26, 2024Pruitt Carotid Shunts SGS May 24, 2024Flexcel Carotid Shunts SGS May 24, 2024AnastoClip Closure Systems SGS May 24, 2024

The indications for use under the new CE mark for XenoSure no longer include neuro or cardiac applications, indications for which the product was approved under its prior CE mark. Additionally, only XenoSure made from bovine pericardium sourced from certain of our suppliers is permitted to be sold under the new CE mark.

Andrew Hodgkinson, SVP of Clinical, Regulatory & Quality Affairs, said, "While our customers have largely enjoyed uninterrupted supply of most of these devices due to inventory stockpiles and local derogations, we are pleased to have received these five CE marks before the transition to the new Medical Device Regulation in the EU on May 26, 2021. We emerge from this transition having lost CE marks on several smaller product lines totaling just 3% of our 2019 EMEA sales."