Business
PAVmed Announces FDA 510(k) Re-submission for its CarpX™ Minimally Invasive Carpal Tunnel Device
Incorporates data from successful clinical safety study in which all patients met pre-specified safety and effectiveness endpoints NEW YORK, March 09, 2020
About this update from Pavmed Inc.
[{"type":"text","content":"Incorporates data from successful clinical safety study in which all patients met pre-specified safety and effectiveness endpoints\n NEW YORK, March 09, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of a 510(k) premarket notification submission for the Company’s CarpX™ minimally invasive carpal tunnel device. This re-submission incorporates data from the Company’s successful first-in-human CarpX clinical safety study, in which all patients met the study’s pre-specified safety and effectiveness endpoints. “We look forward to completing the U.S. regulatory process for CarpX so we can begin offering this groundbreaking technology for alleviating carpal tunnel syndrome to physicians and their patients,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “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. 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.” PAVmed is seeking FDA 510(k) clearance to market CarpX for minimally invasive carpal tunnel release. Extensive pre-clinical testing, performed under close FDA consultation, demonstrated that CarpX was safe, effective and substantially equivalent to the selected predicate. This testing specifically documented a very precise thermal profile, with negligible thermal energy spread beyond the target tissue cut line, as recommended by the FDA. The FDA subsequently recommended a clinical safety study to support 510(k) re-submission. The Company consulted closely with the FDA during development of the study protocol, which it then utilized in its recently completed CarpX first-in-human clinical safety study. Twenty carpal tunnel syn...