PAVmed Receives FDA 510(k) Clearance for CarpX Minimally Invasive Carpal Tunnel Device
PAVmed Inc., a medical device company, announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its CarpX minimally invasive carpal tunnel device.
The FDA determined that CarpX is “substantially equivalent to legally marketed predicates” and that PAVmed may market CarpX for “the minimally invasive isolation and incision/division of ligaments, tendons, or fascia such as the transverse carpal ligament for treatment of carpal tunnel syndrome.” The FDA reached this determination after reviewing detailed data from the Company’s successful CarpX clinical safety study performed in New Zealand.
“We are very excited to introduce CarpX as the first 510(k)-cleared minimally invasive device to utilize common catheter, balloon and wire techniques to facilitate carpal tunnel release,” said Lishan Aklog, M.D., Chairman and CEO, PAVmed. “We believe CarpX will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society, by dramatically reducing recovery times compared to traditional open surgery – an estimated billion-dollar U.S. market opportunity. We look forward to offering CarpX’s benefits to patients and their physicians following its upcoming commercial launch. We have identified an outstanding national sales manager candidate with over twenty-two years of experience calling on orthopedic and hand surgeons to lead this effort, working closely with our clinical, manufacturing and commercial teams.”
“This very important milestone could not have been reached without the tenacious hard work, singular expertise, and relentless perseverance of our entire team, including our world-class regulatory consultants at Hogan Lovells, LLP and product development and manufacturing partners at Sage Product Development, Inc.,” Dr. Aklog added. “We also owe a debt of gratitude to the team at the FDA for completing their work expeditiously, despite the strain on resources from the current pandemic.”
“Observations from our clinical safety study strongly support CarpX’s clinical and commercial potential,” said Brian J. deGuzman, M.D., PAVmed’s Chief Medical Officer, who trained the surgeons and was present in the operating room for all procedures. “CarpX performed flawlessly as a precision cutting device, consistently and cleanly cutting the ligament without evidence of thermal spread beyond the target tissue cut line. Procedure times fell after a short learning curve, indicating the CarpX procedure can be performed in the same or less time as traditional open carpal tunnel release, using 5-10 mm keyhole incisions and with no incision crossing the base of the palm, the problematic area for healing, recovery and persistent pain after traditional surgery. CarpX’s balloon also appeared to create more space within the carpal tunnel at completion of the procedure which has the potential to enhance both short and long-term outcomes.”
As previously announced, all twenty patients in the Company’s successful CarpX clinical safety study in New Zealand underwent successful CarpX minimally invasive carpal tunnel release and met the pre-specified effectiveness endpoint – clinical device technical success defined as the endoscopic confirmation of complete division of the transverse carpal ligament. Two-week and 90-day post-operative follow-up rates were 100% and 95%, respectively. All patients who completed follow-up also met the study’s pre-specified primary safety endpoint – device safety defined as no serious device-related adverse events. Results of additional pre-specified outcome assessments were excellent and similar to, or better than, expected results following traditional open carpal tunnel release.
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