New York-based medical device firm PAVmed has announced that its carpal tunnel device CarpX has been granted CE Mark certification. Securing the CE Mark means that the minimally invasive device can now be marketed in European countries, including in the UK until July 2023.
CarpX enables physicians to relieve median nerve compression in carpal tunnel sufferers without the need to make a surgical incision. The percutaneous technology utilises a balloon catheter and bipolar RF (radio-frequency) electrodes which can cut scarred ligament from outside of the skin in seconds. The device is positioned using ultrasound guidance.
The single-use, disposable device aims to treat carpal tunnel while simultaneously reducing recovery times for patients. It is designed to replicate as closely as possible the results of invasive surgery for carpal tunnel syndrome, in a non-invasive way. CarpX has already received FDA clearance in the US.
Commenting on the CE Mark certification, PAVmed Chairman and Chief Executive Officer Lishan Aklog, M.D., said: “This important milestone is a testament to the tenacity, skill and hard work of our team, led by our Director of Quality, Matt Ennis.”
“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.”