In an exciting development, the U.S. Food and Drug Administration received 510(k) clearance for the use of Apyx Medical’s Renuvion APR Handpiece for certain skin tightening procedures. This means Renuvion treatment has been recognized by the FDA as a successful treatment in improving the appearance of lax or loose skin in the neck and submental region (the area just below your neck).
“Apyx Medical is proud to announce the receipt of this FDA 510(k) clearance, as now Renuvion skin tightening in St Louis is the only device that is FDA-cleared for improving the appearance of loose skin on the neck and chin,” says Charlie Goodwin, President and Chief Executive Officer, in a news release. “This represents a watershed moment for our Company on our journey to revolutionize the cosmetic surgery market by bringing transformative solutions to our customers. We can now market and sell Renuvion to surgeons and patients for use in the approximately 200,000 neck contouring procedures performed in the U.S. annually. Our clinical and regulatory teams have worked diligently over multiple years to make this achievement possible, and I would like to thank them for positioning us to achieve this clearance. As a reminder, our 510(k) submission for this indication was supported by safety and efficacy data from a U.S. IDE clinical study focused on the use of Renuvion in these procedures, and we announced the results of this study in a press release on July 8th.”
Mr. Goodwin continues: “We are excited to receive our first regulatory clearance for contouring procedures, and our second regulatory clearance for a specific clinical indication in less than two months, which further demonstrates our Company’s commitment to bringing evidence-based medicine to this industry. Building on this important achievement, we expect to commence a limited launch of Renuvion for this indication by the end of the third quarter of 2022, with the goal of entering full commercialization by the end of 2022. We are excited to make our Renuvion available to surgeons and patients seeking a new, clinically-proven treatment option to improve the appearance of lax, or loose, skin, and look forward to discussing this new clearance in further detail during our second-quarter earnings call on August 11th.”
As our bodies age, it’s only natural to lose skin tone and elasticity. This can result in a sagging appearance anywhere on the body, from the jowls to the arms to the neck to the buttocks. While a prescription of diet and exercise can work for many when it comes to weight loss, saggy or loose skin can feel like a helpful problem to conquer. Unlike resurfacing treatments that can treat surface issues but don’t do much for sagging, Renuvion remodels the top layer of skin and tightens underlying layers, producing a smoother and noticeably lifted appearance. Effects are visible during treatment, so the procedure allows for precision. Renuvion can be used in many areas of the face and body. From facial rejuvenation to neck wrinkles to sagging of the buttocks, Renuvion has proven to be effective. In fact, the Renuvion treatment was recently listed by RealSelf as one of the most pivotal moments in plastic surgery from the past 15 years!
Renuvion allows us to tighten saggy areas without the need for open surgical intervention. It is ideal for patients who are experiencing some degree of loose skin which skin resurfacing and injectable fillers are not able to fully correct. Patients seeking a minimally invasive procedure that successfully tightens skin in problematic areas of the body may want to consider Renuvion. An innovative solution to skin tightening that eliminates the need for major incisions, Renuvion is commonly referred to as J-Plasma.
Renuvion is unique in its approach to treating skin that has lost elasticity through the dual use of radiofrequency energy and helium plasma to deliver precise and effective results. Initially, the plasma is introduced as an inert gas, but a directed waveform converts it into a plasma that both heats and cools tissue upon contact.
A combination of helium plasma and radiofrequency energy can then be applied to problematic areas of the skin through a small tube at an injection site. While many patients find Renuvion to be extremely effective for skin tightening of the stomach area, it’s proven equally effective at tightening the skin around the legs, back, breasts, thighs, and arms. The precision of this type of treatment means patients don’t have to worry about unintended trauma to surrounding skin tissue. While the benefits of this treatment are vast, we’ve put together three quick summaries of why you want and need it to address any areas you’re worried about excess sagginess in.
Renuvion is considered a minimally invasive procedure because it can be done without skin excision or cutting. The device is inserted under the skin through small entry points, which reduces post-operative discomfort and scarring.
The exclusive use of a local anesthetic to help keep patients comfortable makes Renuvion an extremely safe and highly effective procedure. The elimination of general anesthesia reduces all the risks associated with surgical infections or lengthy hospital stays. Similarly, using a small-incision approach ensures patients do not have to deal with caring for an incision point over an extended period of time. The effects of local anesthesia generally wear off the same day as the procedure is completed and patients should need nothing more than a small bandage at the site of treatment. Overall, patients find Renuvion to be an extremely painless procedure that provides dramatic results without an extensive amount of time dedicated to recovering.
With the use of small entry points and minimal disruption of the tissue, patients experience less pain, discomfort, and downtime with Renuvion compared to more invasive procedures such as abdominoplasty, Brachioplasty, or other procedures where large skin excisions are made. Additionally, studies have shown reduced pain and downtime after the use of Renuvion versus alternative minimally invasive RF technology. The use of helium gas produces a cooling effect that mitigates any discomfort or pain during treatment. Post-treatment discomfort for treatment of smaller areas is typically managed with OTC pain medication alone.
The minimally invasive nature of Renuvion means patients can expect the procedure to be completed in the comfort of the attending physician’s office within 1-hour. A local anesthetic is applied to the injection site to ensure a painless and smooth experience for every patient. Those who elect this treatment should expect to be able to walk out of the office post-procedure without assistance and will likely experience only minimal bruising or redness at the site of treatment. Most patients report swelling disappearing within a few days of the procedure and find over-the-counter pain medications to be sufficient in treating any discomfort. Many patients return to a normal work routine within 2-5 days of receiving treatment and in general, normal exercise routines can be resumed within 2-3 weeks of undergoing Renuvion. Patients will notice physical changes and results related to treatment up to several months after the procedure has been performed. As skin cells continue to adjust, fluctuate and tighten, improved results will continue to be experienced.
Where most non-surgical approaches require multiple treatments to see noticeable results, Renuvion skin tightening in St Louis usually delivers with just one treatment! It is the only device that uses helium and RF waves to create a stream of plasma energy. This unique technology delivers a level of efficacy that’s unmatched. We know the aging process can’t be stopped, but through the use of energy devices, like Renuvion, we know it is possible to contract soft tissues and start the collagen rebuilding process known as neocollagensis. This process takes 6-9 months which is why effects will improve over time.
The cost of skin tightening treatment fluctuates with the size of the area being treated. This means that final costs could be very different from patient to patient. It’s important that patients speak with their insurance providers prior to receiving treatment to see whether the cost of services might be covered under their plan. While many insurance providers consider skin tightening treatments to be elective and therefore, an out-of-pocket expense, those with underlying medical conditions will want to verify before establishing a treatment plan. In some cases, cosmetic services that have the potential to prevent future medical complications may be covered at cost. In the event prospective patients are looking for services exclusively aimed at achieving cosmetic results, the team at the St. Louis Laser Lipo and Vein Center is happy to speak with you about the many financing options we offer.
Before deciding if Renuvion is right for you, it’s important to schedule an initial consultation and take time to speak with a physician more in-depth about what the procedure entails and the aesthetic goals you’ve set for yourself. Every patient is unique and our team is proud to provide a comprehensive approach to patient care. Every patient’s full medical profile and personal preferences are taken into account before an individualized plan of treatment is put into place.
An initial consultation is an important step in establishing a trusting foundation with an attending physician and finding time to ask the important questions you may have before electing to undergo a certain type of procedure. Additionally, it’s a great time to voice any concerns and cover the many service options available to our patients when it comes to cosmetic alterations. When you’re considering skin tightening services, contact us to set up a consultation and start the discussion around Renuvion. We’re here to help make sure your experience with us is as safe, comfortable, and successful as possible.