PAVmed completes clinical safety study procedures for CarpX 510 resubmission
PAVmed announced that all 20 patients of its first-in-human 510(k) clinical safety study underwent successful CarpX procedures. The study is being conducted to support PAVmed's planned 510(k) re-submission to the U.S. FDA seeking marketing clearance of its CarpX minimally invasive carpal tunnel release device. "We are excited to have achieved this critical milestone," said Lishan Aklog, M.D., PAVmed's Chairman and CEO. "Our success with this study brings us one step closer to fulfilling our mission to transform how carpal tunnel syndrome is treated for millions of people worldwide, representing a billion-dollar market opportunity in the U.S. alone. CarpX performed flawlessly as a precision cutting device in these 20 consecutive patients. Using CarpX, surgeons were able to replicate the outstanding results of our pre-clinical testing and achieve the same anatomic results as traditional open surgery - complete and precise cutting of the transverse carpal ligament - using a minimally invasive approach." As per the protocol, patients are undergoing post-operative clinical follow-up at two weeks and 90 days. All of the patients who have completed their follow-up have passed the study's specified primary safety endpoint and, based on clinical observations, it is expected that all of the remaining patients will as well. PAVmed will resubmit the CarpX 510(k) application incorporating the clinical safety and effectiveness data from the study once 90-day follow-up is completed in all 20 patients.