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.

MARLBOROUGH, Mass., June 28, 2023 /PRNewswire/ -- Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the Vbeam Family of Pulsed Dye Lasers (PDL) has expanded its FDA cleared indications for use of the 595 nm wavelength to include the pediatric population (from birth ? 21 years of age) for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas.^*

Port wine stains affect 1 in every 300 infants, and over time usually get darker and thicker, making early onset treatment critical for optimal results.¹ Early treatment of PWS during childhood leads to the best clinical response.² The incidence of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, with a reported rate ranging from 1.1 to 2.6% .³ It is also believed that hemangiomas grow rapidly during the first months of life. The Vbeam 595 nm PDL is world recognized as the gold standard treatment for PWS^4,5 and the primary choice for hemangioma treatment in pediatric patients.^3,6 It stops hemangioma growth, reduces the lesion, and accelerates hemangioma regression, especially in the superficial IH, without serious side effects.^3,6

In 33 peer-reviewed published studies conducted globally, the Vbeam 595 nm PDL was proven to be gentle enough for use in >6,000 pediatric patients with PWS/hemangiomas, while powerful enough to deliver effective and durable results.* The Vbeam 595 nm PDL incorporates the optimal wavelength to penetrate through the target vessels, optimal pulse durations for heating of larger caliber blood vessels, and epidermal protection with its pioneering dynamic cooling device (DCDtm) to deliver higher clinical efficacy for these PWS cases.^4-7 Vbeam 595 nm PDL treatment during infancy can be done without general anesthesia, which offers a safety advantage over repeated treatments performed under general anesthesia, and it can maximize the likelihood of clearance with frequent but safe treatment sessions.⁵ In fact, the Vbeam 595 nm PDL has been chosen by leading hospitals, 8 out of 10 of the top U.S. children's hospitals**, and dermatologists worldwide, exemplifying the power of the Vbeam 595 nm PDL clinical results.

"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.", states board-certified cosmetic dermatologist, Roy G. Geronemus, M.D., Director of the Laser & Skin Surgery Center of New York^®, who provided a recommendation letter to the FDA for clearance of Candela's Vbeam Family of 595 nm PDLs in the pediatric population. "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."⁵

"The new Vbeam 595 nm PDL clearance adds to the already impressive capabilities of this platform. Candela continues to invest not only in clinical research that will allow physicians to give the necessary care to their patients, but also in our philanthropic partnership with the Vascular Birthmark Foundation. With decades of proven results with the Vbeam PDL, Candela is dedicated to advancing clinical care, and this one-of-a-kind clearance is a big step forward in our mission to improve patients' lives," said Geoff Crouse, CEO of Candela.

*Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) FDA 510(k) Premarket Notification [K230990], June, 2023.

**Listed by US News & World

References

1. Vascular Birthmarks Foundation. Port Wine Stain Birthmark. (https://birthmark.org/birthmark/port-wine-stain/) Accessed May 8, 2023.

2. Thajudheen CP, Jyothy K, Priyadarshini A. Treatment of port-wine stains with flash lamp pumped pulsed dye laser on Indian skin: a six year study. J Cutan Aesthet Surg. 2014 Jan;7(1):32-6.

3. Zhang W, Li F, Yang Y, Xue L, Cao M, Wang L. Hemangioma treatment with pulsed dye laser-distinct parameters used between neonatal and non-neonatal patients. J Cosmet Laser Ther. 2016 Nov;18(7):389-392.

4. Brauer JA, Farhadian JA, Bernstein LJ, Bae YS, Geronemus RG. Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains. Dermatol Surg. 2018 Feb;44(2):220-226.

5. Jeon H, Bernstein LJ, Belkin DA, Ghalili S, Geronemus RG. Pulsed Dye Laser Treatment of Port-Wine Stains in Infancy Without the Need for General Anesthesia. JAMA Dermatol. 2019 Apr 1;155(4):435-441.

6. Yang B, Li L, Zhang LX, Sun YJ, Ma L. Clinical Characteristics and Treatment Options of Infantile Vascular Anomalies. Medicine (Baltimore). 2015 Oct;94(40):e1717. doi:10.1097/MD.0000000000001717.

7. Bernstein EF. High-energy 595 nm pulsed dye laser improves refractory port-wine stains. Dermatol Surg. 2006 Jan;32(1):26-33.

CONTACT: Laurel Sanderson, laurels@candelamedical.com

SOURCE Candela