Apyx Medical Corp.—developer of Helium Plasma Technology, which is marketed and sold as Renuvion® in the cosmetic surgery market and and J-Plasma® in the hospital surgical market—has been notified by the U.S. FDA that the agency intends to post a Medical Device Safety Communication related to Apyx Medical’s Advanced Energy products.
The FDA posts a Medical Device Safety Communication, or MDSC, to provide public information about an emerging signal, and it is intended to give healthcare providers, patients, and consumers access to the most current information about a device that may help inform their patient management decision-making.
A MDSC typically includes a summary of the safety concern, recommendations for patients and caregivers, any additional recommendations for healthcare providers or manufacturers, and any actions FDA intends to take to resolve the safety concern.
“Based on our initial interactions with the FDA, we believe the agency’s MDSC will pertain to the use of our Advanced Energy products outside of their FDA-cleared indication for general use in cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures,” says Charlie Goodwin, Apyx Medical’s president and CEO. “We support the FDA’s focus on ensuring that healthcare providers and patients understand the safe and proper use of our products, as we continue to work toward securing 510(k) clearance for additional indications.”
“While we are aware that some of our products are being used by physicians for dermal resurfacing procedures, for which our products do not have a cleared indication, we do not and will not promote the use of our products—or train physicians—for these procedures until we receive clearance from the FDA,” Goodwin adds. “Our labeling specifically warns against the use of our products for this indication as well.”
What’s more, Goodwin says, “We have been actively engaged with the FDA to obtain 510(k) clearance for an on-label indication and have conducted clinical studies, including our recently published U.S. IDE clinical study focused on dermal resurfacing procedures, to address the need for scientific evidence and necessary information in our labeling.”
FDA Recommendations for Healthcare Providers
Per the FDA, here are the recommendations regarding Renuvion for healthcare providers:
- Be aware that the use of Renuvion/J-Plasma is not cleared or approved by the FDA for any aesthetic skin procedure.
- Be aware that the use of Renuvion/J-Plasma for aesthetic skin procedures may result in serious and potentially life-threatening adverse events.
- Do not use the Renuvion/J-Plasma device for dermal resurfacing or skin contraction, alone or in combination with liposuction.
- Discuss the benefits and risks of all available aesthetic skin procedures with your patient. If you are performing an aesthetic procedure, inform your patient which devices you plan to use.
- Review the Apyx Renuvion/J-Plasma labeling and User Manual for proper use of this medical device.
- Report any problems or complications experienced by patients from procedures with Renuvion/J-Plasma to the FDA.