Recros Medica announced in early May that the FDA accepted the company’s de novo submission for the Nuvellus Focal Contouring System. The system includes Recros Medica’s proprietary Rotational Fractional Resection technology, which the company claims is a minimally invasive single treatment to improve submental contouring.
Anticipating the FDA clearance in the fourth quarter of this year, Recros Medica plans to first launch Nuvellus to a limited number of medical aesthetic providers followed by a broad market rollout.
“[Rotational fractional resection] uses small rotating cylindrical scalpels to excise loose skin and a rotating lipectomy cannula that can focally remove fat through the little access ports that are made with these cylindrical scalpels," explains Hema Sundaram, M.D., in a previous article.1
On May 20, 2019, Recros Medica announced results of a 90-day submental contouring study looking at Rotational Fractional Resection’s safety, efficacy and patient satisfaction.
Researchers studied 31 adults with mild to moderate skin laxity and excess fat. While 99% of subjects were dissatisfied with the appearance of their neck and jawline prior to treatment, seven days after a single Rotational Fractional Resection treatment, 84% were satisfied with how they looked in that area; 82% of those studied were still satisfied 90 days post treatment. At 90 days, 94% of subjects said they’d recommend the procedure to friends and family.
“In addition to presenting favorable safety and satisfaction profiles, [Rotational Fractional Resection] demonstrated visible improvements when assessed by independent, blinded physician evaluators not affiliated with the clinical trial. These physicians were able to identify 95% of day 90 post-treatment images compared to baseline photographs. Digital image analysis performed by Canfield Scientific provided quantitative correlation with these blinded evaluations, indicating that 72% of treated patients had a significant reduction in measured surface area,” Dr. Sundaram said in a Recros Medica press release about the study.
Among the most common adverse events related to Rotational Fractional Resection treatment included: 16% experienced bruising, 6% erythema, 6% contact dermatitis, 6% hypoesthesia and 4% bleeding.
Physicians perform submental contouring with Rotational Fractional Resection with aseptic technique under local anesthesia, typically in an office-based treatment room equipped for an ambulatory procedure, according to the company.
“An elastic adhesive membrane, applied immediately after the procedure, helps achieve directional closure of the resected sites to facilitate post-procedural recovery and optimize contouring results,” according to the press release.
Plastic surgeon Edward Knowlton, M.D., who invented Thermage and the Viveve System, cofounded Recros Medica and invented Rotational Fractional Resection.
1. Sundaram, Hema. A First Look at Rotational Fractional Resection. Practical Dermatology. December 2018. Accessed online Aug. 27, 2019. Available at: http://v2.practicaldermatology.com/2018/12/a-first-look-at-rotational-fr....