LeMaitre 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 Date|
|XenoSure biologic patches||TUV SUD||26 May 2024|
|AlboGraft polyester vascular grafts||TUV SUD||26 May 2024|
|Pruitt carotid shunts||SGS||24 May 2024|
|Flexcel carotid shunts||SGS||24 May 2024|
|AnastoClip closure systems||SGS||24 May 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 and 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 26 May 2021. We emerge from this transition having lost CE marks on several smaller product lines totalling just 3% of our 2019 EMEA sales.”