LeMaitre Regains CE Mark for Five Vascular Devices

May 25, 2021— LeMaitre Vascular, Inc. announced that it received CE Marks under the European Medical Devices Directive (93/42/EC as amended by 2007/47/EC) for five products. The CE Marks had previously lapsed due to a change in notified bodies.

The devices included XenoSure biologic patches, AlboGraft polyester vascular grafts, Pruitt carotid shunts, Flexcel carotid shunts, and AnastoClip closure systems.

The company advised that 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 previous CE Mark. Additionally, only XenoSure made from bovine pericardium sourced from certain of the company’s 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 European Union on May 26, 2021. We emerge from this transition having lost CE Marks on several smaller product lines totaling just 3% of our 2019 [Europe, Middle East, and Africa] sales.”