The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the New York-based company said.
Pavmed said that the first group of nine patients have been treated with the device, and that the procedures were performed at Cristchurch, New Zealand’s St. George’s Hospital by Dr. Terrence Creagh and Dr. Howard Klein.
Patients in the trial will undergo a post-operative clinical follow-up at two weeks and 90 days, with repeat electrodiagnostic testing during the 90-day follow-up to document the protocol’s safety endpoint.
Pavmed said that another group of patients are scheduled to undergo procedures with the device in the coming weeks.
“I would like to thank Terrence Creagh and Howard Klein for their extraordinary efforts in helping us reach this major milestone. The surgeons were able to replicate the outstanding results of our pre-clinical testing in actual patients with carpal tunnel syndrome. These first CarpX procedures achieved the same anatomic result as traditional open surgery, namely complete division of the transverse carpal ligament, using the device’s minimally invasive approach. Endoscopic visualization showed that the cuts were precise and clean, without charring, in every case, consistent with our preclinical experience,” chief medical officer Dr. Brian deGuzman said in a press release. “We learned a tremendous amount from these initial human cases. The CarpX procedure was technically straightforward with a short learning curve. Procedure times fell rapidly with each successive case and should be similar to or possibly shorter than traditional surgery. We were also impressed with how much space the CarpX device’s balloon created within the carpal tunnel at completion of the procedure compared to traditional surgery. This unique feature has the potential to enhance the procedure’s short and long-term outcomes. Finally, certain procedural steps were successfully enhanced to address anatomic and tissue property differences between normal cadavers and living patients with carpal tunnel syndrome. In particular, the CarpX device required less power and lower balloon pressures to cut the ligament in human patients than it had in cadavers, an unexpected positive finding which should further enhance the procedure.”
In August last year, the FDA group reviewing Pavmed’s 510(k) application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. In January, the company said it had plans to launch the study.