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Vbeam 595 nm Pulsed Dye Laser Achieves FDA Clearance for Treating Port Wine Stains and Hemangiomas in Pediatric Patients, Making History as the First of its Kind

Thursday, June 29, 2023

Candela Corporation, a prominent global medical aesthetic device company headquartered in Marlborough, MA, has made an announcement regarding the Vbeam Family of Pulsed Dye Lasers (PDL). The company has received an expanded FDA clearance for the use of the 595 nm wavelength in treating cutaneous capillary malformations, commonly known as port wine stains (PWS), and infantile hemangiomas in the pediatric population (from birth to 21 years of age).

Port wine stains affect approximately 1 in every 300 infants and tend to darken and thicken over time, making early treatment crucial for optimal results. Infantile hemangiomas have varying incidence rates in neonatal patients and are known to grow rapidly during the first months of life. The Vbeam 595 nm PDL is recognized as the gold standard treatment for port wine stains and is the preferred choice for pediatric hemangioma treatment, effectively stopping growth, reducing lesions, and accelerating regression, particularly in superficial cases.

The effectiveness and safety of the Vbeam 595 nm PDL have been validated through numerous peer-reviewed studies involving over 6,000 pediatric patients. The laser's optimal wavelength enables penetration into target vessels, while its dynamic cooling device (DCD™) ensures epidermal protection, resulting in excellent clinical efficacy for treating port wine stains. Importantly, using the Vbeam 595 nm PDL during infancy eliminates the need for general anesthesia, providing a safer approach compared to repeated treatments under anesthesia.

The Vbeam 595 nm PDL has been widely adopted by renowned hospitals, including eight of the top U.S. children's hospitals, as well as dermatologists worldwide, further emphasizing its clinical success. This recent FDA clearance further expands the capabilities of the Vbeam 595 nm PDL platform. Candela remains committed to advancing clinical care and supporting philanthropic initiatives, such as its partnership with the Vascular Birthmark Foundation, to improve the lives of patients.


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