First-in-Class Device for Facial Wrinkles Hits the Market

Doug Brunk

October 28, 2022

DENVER – One expert's clinical experience suggests that Ellacor, a dermal microcoring device that became available in the United States in October 2022, is an effective treatment for facial wrinkles and tightening.

Dr Mathew Avram

"It's early yet, but I have treated dozens of patients with this device, and they have been happy with the results," Mathew M. Avram, MD, JD, said at the annual meeting of the American Society for Dermatologic Surgery. "This is a new technique that offers the ability to remove a significant amount of damaged, lax skin without concern for scarring," he said.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the first-in-class device is cleared by the Food and Drug Administration for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

"It doesn't do anything equivalent to a facelift, but the concept is a facelift by thousands of micro-punch excisions," said Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. "Rather than pulling up the skin and lifting it and cutting the excess skin like we do with a facelift, we are creating thousands of smaller-scale tissue removals with immediate closures to do the same thing. The micro-cores are about the size of a 22-gauge needle and there is no scarring due to the small size of these tissue extractions."

The device features needle cartridges capable of excising up to 24,000 cores per treatment. According to data from Cytrellis, the manufacturer, the equivalent of about 2 inches of skin can be removed during the procedure, which typically takes fewer than 30 minutes to perform. "There is no heat whatsoever," Avram said. "In my experience, it especially helps with jawline definition, the lower medial cheek excess skin, and accordion lines in that area."

In a pivotal trial of the device, 51 patients with mid to lower face wrinkles (moderately deep or deep wrinkles with well-defined edges) were treated 2-3 times with 7%-8% skin removal and up to a 5-mm needle coring depth). The investigators found that 40% of study participants achieved an improvement of 2 grades on the Lemperle Wrinkle Severity Scale and that the rate of overall satisfaction (slightly, somewhat, and extremely satisfied) was 86%.

In addition, 90% showed improvement of treated sites on the Global Aesthetic Improvement Scale, and 70% were comfortable enough to go out in public or return to work 3 days after treatment. Common side effects that can occur immediately post treatment include redness, swelling, and pinpoint bleeding, which typically clear in a few days.

Avram, immediate past president of the ASDS, has posted videos to his Instagram feed that show him treating patients with the Ellacor device and he admits that the procedure looks painful. "There are all these tear emojis and people cursing me out," he said, referring to responses from his Instagram followers.

Proper local anesthesia prior to treatment is key. "I perform nerve blocks and infiltrate the skin," he said. "You have to cover the whole treatment area. If you don't, then it's going to hurt. The average pain score is 1.9 out of 10. The highest pain score I've gotten from a patient is a 3 out of 10."

Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, and Soliton, and has ownership and/or shareholder interest in Cytrellis.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

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