PAVmed Inc. has announced the successful completion of a pre-clinical human cadaver study. According to the June 23, 2016 news release, the study has shown “that the Company’s completely percutaneous CarpX device reliably and effectively transects the ligament which causes carpal tunnel syndrome (CTS).”
Lishan Aklog, M.D., Chairman and CEO of PAVmed, said, “We are excited to report that CarpX performed very well in this important pre-clinical study. The device consistently cut the ligament from the inside out, replicating the anatomic result of traditional, invasive carpal tunnel surgery, but without the need for a surgical incision.”
“In accordance with PAVmed’s proven business model, we are now aggressively proceeding towards completion of commercial design, validation/verification testing and FDA submission with clearance and commercialization targeted for 2017. We estimate the market opportunity for CarpX to be over $1 billion based on the current rate of surgical procedures, ” Dr. Aklog concluded.
As indicated in the news release, “CarpX consists of a balloon catheter with integrated bipolar radiofrequency cutting electrodes, which is introduced into the carpal tunnel percutaneously over a guidewire, without an open surgical incision. Once its position is confirmed by ultrasound, the balloon is inflated, stretching the TCL [transverse carpal ligament] over the electrodes and pushing the median nerve and other structures safely away. A brief burst of radiofrequency energy cuts the ligament, relieving the compression of the median nerve.”
“CarpX was tested in 14 human cadaver arms. In one group, the device was positioned within the carpal tunnel, after exposing the TCL, to directly observe the cutting of the ligament. In a second group, the device was inserted percutaneously under ultrasound guidance. The device reliably and effectively cut the ligament, cleanly and without charring or collateral injury, in under 1.5 seconds. The full data from the study will be submitted for publication in a peer-reviewed journal.”
Dr. Aklog told OTW, “We believe that CarpX has the potential to revolutionize the care of patients suffering from carpal tunnel syndrome by allowing hand surgeons to provide them with an completely percutaneous option. Many patients who currently suffer in silence because they want to avoid open surgery at all costs will likely consider earlier intervention.”
“Carpal tunnel surgery is very effective and has excellent results. CarpX is designed to mimic the surgical results from an anatomic and functional point of view but with a completely percutaneous approach, cutting the transverse carpal ligament from the inside out instead of through an open incision.”
“PAVmed is working to finalize the commercial design of the product (ergonomics, human factor analysis, electronic feedback, etc.) and will then proceed to full validation/verification testing prior to FDA submission in 2017. Once cleared PAVmed will work closely with key opinion leaders to optimize the procedural elements and iterate the design of device based on clinician feedback.”
