Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication

Apyx Medical (NYSE:APYX), formerly known as Bovie Medical, said late yesterday that it has voluntarily withdrawn the FDA 510(k) clearance application for its J-Plasma/Renuvion device seeking a dermal resurfacing indication. The Clearwater, Fla.-based company submitted a new 510(k) clearance application seeking new indications for the Renuvion system in December. The application came supported by by data from a 55-patient, multi-center, single arm, evaluator-blind prospective investigational device exemption study of the system exploring its ability to reduce facial wrinkles and rhytides, Apyx Medical said. The study, however, did not meet its primary efficacy endpoint, a comparison of the proportion of subjects with a greater than or equal to 1-score improvement on the Fitzpatrick Wrinkle and Elastosis Scale at 3-months. The company hoped to achieve a 75% success rate, but only 62% of subjects showed an improvement of 1 or more on the scale. Apyx Medical said that in reviewing the submission, the FDA had concerns over clinical results from one investigational center being superior to the other two centers in the study. The federal watchdog was also concerned about the potential impact of protocol deviations at the superior center which included the prophylactic use of methylprednisolone in all but 5 subjects. “The IDE study results show good progress towards being able to eventually demonstrate the efficacy of our Renuvion cosmetic technology as more than 90% of subject...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Regulatory/Compliance apyxmedical Source Type: news