FDA Clears Radiofrequency Ablation Device

The US Food and Drug Administration (FDA) has granted clearance for the SIRA RFA Electrosurgical Device to Innoblative Designs, Inc. The device is a radiofrequency ablation (RFA) applicator used in electrosurgery for intraoperative coagulation and soft tissue ablation.

"Receiving FDA clearance is a significant milestone for Innoblative, and we look forward to commercializing the SIRA device in the US market," said Tyler R. Wanke, CEO and Co-founder of Innoblative. "With our initial indication in hand, we continue working towards obtaining additional indications where our novel technology can significantly impact patient care."

The SIRA device applicator was designed to treat large surface areas, unlike typical radiofrequency ablation applicators, and has a 4 cm diameter spherical electrode. Additionally, the device has an integrated saline irrigation system to improve contact with the target tissue, lubricate the electrodes and avoid sticking, and cool the target tissue.

"The large spherical applicator minimizes subjective repositioning of the device, leading to a more controllable and predictable ablation performance,” said Brendan Visser, MD, Associate Professor of Surgery at Stanford University School of Medicine. “A device like this hasn't existed before, and I'm excited to see this advancement in the operating room helping patients."

Andrei Stieber, MD, General Surgeon at DeKalb Surgical Associates and Northside Hospital in Atlanta, Georgia, said that the SIRA device “breaks the usual convention” of radiofrequency ablation and microwave devices that are currently available.

"For surface lesions, SIRA offers an easy to use, intuitive and controllable solution for a common problem in abdominal surgery,” added Stieber. “I believe the SIRA device adds an important tool to the surgeon's armamentarium."