LeMaitre Regains Five CE Marks
LeMaitre (Nasdaq:LMAT) announced the receipt of CE marks for five vascular products after a prior lapse due to a change in notified bodies. The newly certified products include XenoSure Biologic Patches, AlboGraft Polyester Vascular Grafts, and various Carotid Shunts, with expiration dates extending to 2024. Notably, the XenoSure's indications no longer cover neuro or cardiac applications. Andrew Hodgkinson highlighted that despite some product line losses totaling 3% of EMEA sales, customer supplies remained largely uninterrupted due to existing inventory.
- Successfully received CE marks for five key vascular products, enhancing marketability.
- Minimal impact on sales with only 3% of EMEA sales affected by lost CE marks.
- XenoSure's new CE indication excludes neuro and cardiac applications, limiting its market use.
BURLINGTON, Mass., May 25, 2021 (GLOBE NEWSWIRE) -- 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 Date |
| XenoSure Biologic Patches | TUV SUD | May 26, 2024 |
| AlboGraft Polyester Vascular Grafts | TUV SUD | May 26, 2024 |
| Pruitt Carotid Shunts | SGS | May 24, 2024 |
| Flexcel Carotid Shunts | SGS | May 24, 2024 |
| AnastoClip 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
About LeMaitre
LeMaitre is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon.
LeMaitre is a registered trademark of LeMaitre Vascular, Inc. This press release may include other trademarks and trade names of the Company.
For more information about the Company, please visit http://www.lemaitre.com.
FAQ
What new products received CE marks for LeMaitre (LMAT) in 2021?
How does the new CE mark for XenoSure differ from the previous one?
What was the impact of losing CE marks on LeMaitre's sales?
When do the new CE marks for LeMaitre's products expire?
