FDA Clears Vbeam Pulsed Dye Laser for Pediatric Port Wine Stains, Hemangiomas

The US Food and Drug Administration (FDA) has cleared Candela Corporation’s Vbeam 595 mm pulsed dye laser for the treatment of port wine stains and hemangiomas in children, making the device the first of its kind to become available to pediatric patients.

Vbeam handpiece/Candela

Candela announced the device’s expanded clearance via a press release,¹ noting that the device is now cleared for cutaneous capillary malformations in patients ranging in age from newborns to individuals 21 years old.

The device is already approved for adult patients and is considered a first-line treatment for port wine stains and hemangiomas. It uses wavelengths to penetrate and heat blood vessels while also cooling the epidermis for enhanced clinical efficacy, and it can be used without the use of general anesthesia, which is often required in other methods of removal and treatment.

In hemangiomas, the device, “stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH [infantile hemangiomas], without serious side effects.”

"I am fortunate to be one of the original investigators in the use of the pulsed dye laser for cutaneous vascular lesions close to forty years ago," said Roy Geronemus, MD, in the press release.

Geronemus is director of the Laser & Skin Surgery Center of New York and a Dermatology Times® editorial advisory board member.

"Since that time, the focus of my clinical research and clinical practice has been the treatment of port wine stains and hemangiomas in infants and children. My most recent study of 197 infants with port wine stains under the age of 1 year showed dramatic clearing and the highest incidence of clearing to date."

The clearance comes after the publication of 33 peer-reviewed studies conducted internationally. In total, it was found to be both gentle and effective in more than 6,000 pediatric patients.

Reference

1. Candela. The vbeam 595 nm pulsed dye laser, a recognized gold standard for vascular treatment, receives a ground-breaking FDA clearance for the treatment of Port wine stains and hemangiomas in the pediatric population - the first clearance of its kind. PR Newswire: press release distribution, targeting, monitoring and marketing. June 28, 2023. Accessed June 28, 2023. https://www.prnewswire.com/news-releases/the-vbeam-595-nm-pulsed-dye-laser-a-recognized-gold-standard-for-vascular-treatment-receives-a-ground-breaking-fda-clearance-for-the-treatment-of-port-wine-stains-and-hemangiomas-in-the-pediatric-population---the-first-clearance-301865145.html?tc=eml_cleartime.