FDA Clears PAVmed’s CarpX Minimally Invasive Carpal Tunnel Device

PAVmed Inc., a highly differentiated, multiproduct medical device company, 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., PAVmed’s chairman and CEO. “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 a national sales manager candidate with over 22 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 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.”

As previously announced, all 20 patients in the company’s 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 percent and 95 percent, 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.
 
“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.”
 
CarpX is a patented single-use disposable minimally invasive device designed to treat carpal tunnel syndrome while reducing recovery times. 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.