FDA Clears MicroPen EVO for Use in the U.S.

Sponsored by: Eclipse

U.S.-based medical providers now have access to a new microneedling device that has been a big hit in Canada since being introduced there last year. The FDA just announced that it has cleared the MicroPen EVO from Eclipse (The Colony, Texas) for treatment of facial acne scars.

According to Tom O’Brien, CEO at Eclipse, MicroPen EVO is the microneedling pen that the U.S. aesthetic market has been waiting for.“We want this to be the last micronee-dling device that practices in the U.S. feel they have to invest in for the long term.”

Microneedling technology has come a long way.“The origins of microneedling in the clinical setting started with rollers and manual stampers, followed by the introduction of the mechanical and automated pen,” said Michael O’Brien, vice president of strategy at Eclipse.“These original microneedling pen devices were novel, but not very precise nor medical-grade. Many had a cord and they were not designed to last in a high-volume aesthetic practice.”

Despite some of the early devices’ short-comings, microneedling has proven to be safe, effective and often is preferred for treating acne scars and wrinkles, according to authors of a systematic review on microneedling published in 2018 in the Journal of Plastic, Reconstructive and Aesthetic Surgery^.1

According to the article, microneedling showed noteworthy results when used on its own...When compared with other treatments, it showed similar results but was preferred due to minimal side effects and shorter downtime.¹

And, aesthetic physicians embrace micro-needling. In its 2019 Survey on Dermatologic Procedures, The American Society for Dermatologic Surgery (ASDS) reported that microneedling was among the top cosmetic treatments in 2019, with members performing 238,000 microneedling treatments that year^.2

What EVO Brings to the Market

The MicroPen EVO maintained what doctors already love about the original devices, and then improved upon the microneedling pen concept, according to M. O’Brien.

"It is the most precise pen in terms of the tissue effect and its clinical outcomes,” M.O’Brien said.“But it is also a device that practitioners are going to enjoy using and really fall in love with in terms of how it feels in their hands and how it operates."

EVO was designed and is manufactured in the U.S., with features that make it easy to use, such as a lightweight aerospace-grade alloy body, a fluid-resistant turbo safety cartridge and wireless charging.

The cartridges are easy to apply. There are no cords getting in the way during treatment. And the device is reliable, with a removable lithium-ion battery that quickly charges, wirelessly, so that operators are never left in a lurch, unable to finish a case, according to M. O’Brien.

"The EVO’s battery life is four to eight hours,” M. O’Brien noted.“The recharge time is the shortest of any cordless device out there.”

The EVO also offers many built-in safety features.“One of the concerns about the safety of microneedling has to do with the potential for the pinpoint bleeding that occurs on the patient’s skin to be transferred to the pen,” M. O’Brien advised.“Of course, we have a protective sleeve that goes over it to protect the pen. The cartridges are single-use, sterile cartridges, but it is the design of our pen that makes our cartridge the safest on the market. Unlike other devices that require the cartridge to be inserted into the body of the pen, the EVO’s turbo safety cartridge is positioned on the outside of the pen’s body, making it virtually impossible for blood to be pulled into the housing of the pen.”

“You protect the pen with a sleeve and then, after use, you wipe it down with disinfectant and give it one last pass with UV radiation, which will kill anything that may have made accidental contact,” M. O’Brien said.“So, we have what we feel is the safest microneedling concept ever brought to market in terms of reducing the risk of cross-contamination and giving practitioners added assurance of keeping patients safe.”

The EVO is made with high-quality medical-grade stainless steel needles, and a Swiss-engineered high-speed motor for improved treatment efficiency. The device’s needles pulse at 7000 rpms (+/- 10%), with a maximum penetration depth of 2.0 mm.

Well-known innovators and leaders in cosmetic dermatology, Jean Carruthers, MD, and Shannon Humphrey, MD, of Vancouver, British Columbia, were the first practice in North America to upgrade to the new MicroPen EVO.“

MicroPen has been a wonderful addition to our armamentarium of skin rejuvenation tools,” said Dr. Carruthers, who is recognized worldwide for pioneering the cosmetic use of botulinum A exotoxin (Botox) with her husband Alastair Carruthers, MD.

“As a long-time customer of Eclipse, I’ve appreciated their ability to innovate and improve the technologies we use every day,” said Paul Nassif, MD, of Nassif MD Plastic Surgery (Beverly Hills, Calif.).“EVO is the next big thing.”

Minimal Investment. High Return. Low Patient Risk.

Compared to many of the technologies available at U.S. aesthetic practices,microneedling devices are relatively simple and low cost. That’s the beauty of microneedling, according to M. O’Brien.“

Microneedling gives practices a very affordable frontline therapy that delivers results which exceed patient expectations. And when you can deliver that kind of patient satisfaction level in a device that typically does not require any sort of capital lease or debt, practices are happy and so are patients,” M. O’Brien stated.“Microneedling becomes a trust builder with patients in terms of offering them something that is low downtime and affordable,” he continued.“When they see results, they really appreciate the doctor or medical provider for delivering something that works, is not too expensive and does not create a lot of downtime. It is just good business.”

Eclipse has a full team in the field, covering all 50 U.S. states, ready to introduce practices to the EVO.

“During the COVID era, we embraced an online training module that introduces practices to the device when they purchase the system,” M. O’Brien indicated.“We follow up with in-person training. And we are one of the few companies that offers continuing medical education (CME) grants on the front end for our customers so that if they want to receive advanced training, our CME training partners will be able to provide that for them as part of their customer experience.”

References:

1. Microneedling: Where do we stand now? A systematic review of the literature - ScienceDirect. 2018; 70(1):1-4 https://doi.org/10.1016/j.bjps.2017.06.006

2. 2019 ASDS Procedures Survey Release: https://www.asds.net/skin-experts/news-room/press-releases/asds-members-performed-nearly-14-million-treatments-in-2019