New Intradermal Laser Coming to Market

A new focused intradermal laser has come to market, the MIRIA Skin Treatment System. I participated in clinical trials for the device and want to share some of my insights.

What’s Special About This EBD?

There are three areas of novelty that MIRIA by AVAVA offers:

The laser design and Focal Point Technology will be a cornerstone in delivery of energy of the first MIRIA device, a separate device without a launch date yet slated. Both devices have received FDA clearance for the coagulation of soft tissue at 150 mJ. The first device uses a 1550 wavelength and it’s a fractionated non-ablative laser, but the ring geometry shape of the laser allows central sparing of the epidermis and depth control. So, you can focus the maximum energy at the desired depth down to 1.5 mm.

Both these devices have, built into the handpiece, high-resolution imagery like dermoscopy called Intelliview. This allows the practitioner to see areas of the skin they may want to either treat more or less aggressively (like blood vessels or patches of hyper- or hypo-pigmentation, scars, etc.). This high-resolution imaging will eventually allow machine learning in the device to avoid under/over treating especially in patients with varying skin tones in whom you don’t want to treat too aggressively for fear of a post-inflammatory hyperpigmentation (PIH) response.

Both platforms are built on an AI digital infrastructure that creates communication between the patient, the practice, and the device and will allow predictive analytics based on practice and patient behavior. This digital infrastructure can facilitate valuable data insights that will be meaningful to both the practices and the patients.

What It Addresses

Our regulatory strategy includes submitting data to FDA for review of clinical indications such as acne scarring, voluminization, addressing fine and deeper lines and wrinkles, in all skin types from Fitzpatrick Types I–VI.

For Darker Skin Tones and All Skin Types

I think what truly makes it different from other devices is that you can dial up energy safely in darker skin tones. This will be a new workhorse laser for facial rejuvenation. Other energy devices can be painful and require sedation. With other devices like ultrasound, there is also the real risk of nerve injury.

In particular, this is excellent for darker skin tones because you don’t have to deposit energy at the surface but can go directly to depths below the dermal-epidermal junction (DEJ) to bypass melanocytes and avoid a post-inflammatory hyperpigmentation response. So many of the adverse events (AEs) experienced in darker skin types can be avoided (PIH, hypo-pigmentation, etc.) by depositing the max energy below the dermal-epidermal junction.

However, you do want to cause some injury to epidermis, but in a controlled fashion that doesn’t cause collateral damage to surrounding tissue. Many of the lasers I use require me to dial down the energy even to the max of 70 mJ which is the FDA clearance for competitive devices in skin of color for fear that I’m going to incite an AE given the biology of darker skin. When dialing down the energy, I know I’m going to get a less efficacious response. With MIRIA by AVAVA I can treat darker skin tones more comfortably.

It can be used on anyone who wants to have healthier, perfected, corrected skin – all skin types Fitzpatrick I-IV, all ages and sexes.

Combination Therapies

The control over depth allows you to treat both superficially and at deeper depths. I would incorporate it with ablative treatments for patients who like results without the downtime and also in patients who want superficial treatments. It’s going to meet a lot of needs in my practice but I can definitely see offering this to patients who are doing injectables and toxin.

Patients who have never had laser can opt for superficial or more extensive resurfacing given the depth capabilities offered by the MIRIA by AVAVA device.

The Learning Curve and Drawbacks

If clinicians have operated other lasers, the learning curve is pretty quick. It’s an in-contact device, has a large screen and touch screen and is user friendly with an easy-to-operate user interface, has a weightless handpiece, and has high-resolution imaging built into the handpiece with interactive screen viewing and ability to take pictures of areas of interest.

The corporation will be rolling out its early release program (Leaders Early Access Program or LEAP). Downtime? Only two days and no ablation of the skin. The average pain score is 3 and I use topical anesthesia on my patients, who find it quite tolerable.