The company said this clearance makes it the first and only one with an FDA indication for RF ablation of thyroid nodules.
Until now, according to StarMed, patients requiring thyroid nodule intervention had to choose between monitoring or surgery. It says its RF solution provides a minimally invasive, outpatient alternative that preserves the thyroid and avoids surgery.
The FDA-cleared devices include the VIVA combo RF generator, star RF electrodes and VIVA RF electrodes. These devices received clearance for ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules. It covers adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. Autonomously functioning nodules are indicated if nodule volume is less than 10 mL.
StarMed says clearance “may simplify institutional adoption and value analysis review.” It said it can also align device labeling, clinical evidence and CPT coding pathways for thyroid RF ablation.
The company says clearance caps a 24-year journey after the world’s first thyroid RF ablation procedure took place in South Korea, using StarMed equipment, in 2002.
“From the first thyroid RFA procedure ever performed to the first FDA indication in U.S. history, StarMed has been the equipment behind the science,” said Henry Shin, CEO of StarMed. ” This clearance reflects the trust physicians and researchers around the world have placed in our technology for more than two decades.”
