The FDA group reviewing the 510(k) application for Pavmed‘s (NSDQ:PAVM) CarpX device wants the company to resubmit the application.
The FDA told the company that it had not reached a consensus within the review period set by the agency’s rules. To extend the review process, the FDA recommended that Pavmed resubmit the application. In a filing with the SEC, Pavmed said it initiated the submission this week and hopes to land a pre-submission meeting in the next 45 days.
The company’s minimally-invasive CarpX device is designed to treat carpal tunnel syndrome. The device enables a physician to relieve compression of a patient’s median nerve without the use of an incision. The ultrasound-guided system features a balloon catheter with bipolar radio-frequency cutting electrodes, according to Pavmed.
Once the device is activated, it creates a space to protect the nerve from the cutting electrode and decompresses the nerve by dividing the transverse carpal ligament.
“We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions,” CMO Dr. Brian deGuzman explained last year. “Our 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.”