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PAVmed Receives European CE Mark Certification for its CarpX® Minimally Invasive Carpal Tunnel Device
NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product,
About this update from Pavmed Inc.
[{"type":"text","content":"NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- 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® minimally invasive carpal tunnel device. EU-based Notified Body TÜV 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.” About CarpX CarpX is a patented single-use disposable minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery times which has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark (CarpX animation). CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to percutaneous and minimally invasive revolutions in the treatment of other conditions. The balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure. About PAVmed and Lucid PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical technology company with a diversified product pipeline addressing unmet clinical needs encompassing a broad sp...