The US Food and Drug Administration (FDA) has approved Biolase's WaterLase iPlus all-tissue laser for soft-tissue procedures in orthopedic and podiatric surgery as a surgical instrument.
The iPlus has been cleared for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including soft and cartilaginous tissue in small and large joints.
Biolase chairman and CEO Federico Pignatelli said that the company is pleased to receive the non-dental WaterLase clearance related to its revolutionary iPlus.
"This clearance gives us the ability to leverage our flagship iPlus and its related consumables business in the orthopedic and podiatric markets, each with tremendous potential," Pignatelli added.
Biolase Global Clinical Affairs manager Amado Carino said that during the past several years, the use of lasers in orthopedic surgery has become more accepted as a less invasive alternative to conventional surgery and it has become clear that modern lasers will play a significant role in the treatment of musculoskeletal injuries.
"Procedures can include debridement of both healthy and diseased tissue, soft tissue release, tendon transfer, incision, excision, coagulation and hemostasis, and nerve and vascular repair, both in the upper and lower extremities of the human body," Carino added.
