Cutera, a developer of laser and energy-based devices, received FDA-clearance on Dec. 18 for expanded indications of its truFlex muscle stimulation technology. Introduced to the market in 2019 for aesthetic purposes, this clearance adds rehabilitative and therapeutic applications for treating arms and calves muscles.
The newly expanded indications include strengthening, toning and firming the arms and calves; relaxing muscle spasms; preventing or slowing disuse atrophy; improving local blood circulation; supporting muscle re-education; and maintaining or increasing range of motion, according to a Dec. 18 company press release. They also include immediate post-surgical stimulation of the calf muscles to help prevent venous thrombosis, neuromuscular stimulation for bulk muscle excitation in the legs or arms for rehabilitative purposes and use as an adjunctive therapy in the treatment of medical diseases and conditions under medical supervision.
"Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today,” said Taylor Harris, CEO of Cutera. “These new clearances mark an important milestone in Cutera's mission to improve the lives of patients through advanced, versatile solutions that address both aesthetic and therapeutic demand."
Introduced in 2019, truFlex initially leveraged Multi-Directional Stimulation (MDS) technology to generate controlled muscle contractions in specific muscle groups, tailored to a patient’s body shape or treatment area. Now partnering with physicians and rehabilitation specialists, this new implication transforms truFlex from a primarily aesthetic muscle-stimulation solution into a more comprehensive platform that supports enhanced patient wellness and improved clinical outcomes.
"The new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength. Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey," said Edward Alvarez, MD CEO and founder of Restimulate Health.
