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FDA Grants Landmark Clearance for Vbeam 595 nm Pulsed Dye Laser in Treating Pediatric Port Wine Stains and Hemangiomas

Candela Corporation, a prominent global medical aesthetic device company headquartered in Marlborough, MA, has made a significant announcement. The Vbeam Family of Pulsed Dye Lasers (PDL), manufactured by Candela, has received expanded FDA clearance for the treatment of pediatric patients (from birth to 21 years of age) with cutaneous capillary malformations, commonly known as port wine stains (PWS), and infantile hemangiomas (IH) or congenital hemangiomas.

Port wine stains affect about 1 in every 300 infants and tend to darken and thicken over time, emphasizing the importance of early treatment for optimal results. Treating PWS during childhood has been found to yield the best clinical response. The occurrence rate of infantile hemangiomas (IHs) in neonatal patients (under 28 days of age) varies, ranging from 1.1% to 2.6%. Hemangiomas are known to grow rapidly during the first months of life.

The Vbeam 595 nm PDL is widely recognized as the gold standard treatment for PWS and is the preferred choice for hemangioma treatment in pediatric patients. It effectively halts hemangioma growth, reduces lesion size, and accelerates hemangioma regression, particularly in superficial IH cases, without significant side effects. Numerous peer-reviewed studies, involving over 6,000 pediatric patients with PWS/hemangiomas, have demonstrated the Vbeam 595 nm PDL's safety and efficacy.

The Vbeam 595 nm PDL incorporates an optimal wavelength for effectively targeting the affected vessels, precise pulse durations to heat larger blood vessels, and includes an innovative dynamic cooling device (DCD™) for epidermal protection, ensuring enhanced clinical efficacy in treating PWS cases. Importantly, treatment with the Vbeam 595 nm PDL during infancy can be performed without the need for general anesthesia, offering a safety advantage over repeated treatments under general anesthesia and maximizing the likelihood of successful clearance through safe and frequent sessions.

The Vbeam 595 nm PDL has been chosen by leading hospitals and dermatologists worldwide, including 8 out of the top 10 U.S. children's hospitals, reflecting its effectiveness and widespread adoption in clinical practice. This latest FDA clearance for the Vbeam 595 nm PDL further strengthens its capabilities. Candela is dedicated to advancing clinical care, investing in research, and maintaining a philanthropic partnership with the Vascular Birthmark Foundation, as part of its mission to improve the lives of patients.

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