Benzinga | May 25, 2021 09:33AM EDT

PAVmed Says Receives European CE Mark Certification For CarpX Minimally Invasive Carpal Tunnel Device

PAVmed Inc. (NASDAQ:PAVM, PAVMZ))))) (the "Company" or "PAVmed"), a highly differentiated, multi-product, commercial-stage medical device company, today announced that it has received CE Mark certification for its CarpX(r) minimally invasive carpal tunnel device.



EU-based Notified Body T?V Rhineland LGA Products GMBH issued a CE Certificate, effective May 24, 2021, declaring that CarpX conforms to the essential requirements of Medical Device Directive 93/42/EEC. With CE Mark secured, CarpX may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom.

"This important milestone is a testament to the tenacity, skill and hard work of our team, led by our Director of Quality, Matt Ennis," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. "Carpal tunnel syndrome is widely prevalent in Europe and the estimated total addressable market opportunity for CarpX there is at least as large as in the U.S. We look forward to moving towards commercial launch in select European countries in the near future."