In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data from the company’s first-in-human CarpX clinical safety study, in which all 20 patients met the safety and effectiveness endpoints, according to Pavmed.
“We believe the data in this 510(k) re-submission demonstrate the safety and effectiveness of CarpX as well as its substantial equivalence to the predicate device,” said Pavmed CEO Dr. Lishan Aklog in a news release. “As expected, our clinical safety study found CarpX to be a precision cutting device, consistent with its design and the results of extensive pre-clinical testing, meeting both pre-specified safety and effectiveness endpoints, with no device-related adverse events. Based on these results, we believe CarpX has the potential to transform carpal tunnel syndrome treatment by dramatically reducing recovery times compared to traditional open surgery, an estimated billion-dollar U.S. market opportunity.”
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.