CHICAGO, April 9, 2019 /PRNewswire/ — Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.
“The design of the SIRA applicator makes it uniquely suited to ablate large surface areas,” said Dr. Brendan Visser, Associate Professor of Surgery at Stanford University School of Medicine. “The large spherical applicator minimizes subjective repositioning of the device, leading to a more controllable and predictable ablation performance. A device like this hasn’t existed before, and I’m excited to see this advancement in the operating room helping patients.”
Radiofrequency ablation of soft tissue has been shown in multiple long-term clinical studies to reduce complications and reoperations.1 However, current conventional RF applicators are not optimized to treat large surface areas, which can lead to long procedure times and variable ablation depths. Innoblative’s SIRA device is used in conjunction with a radiofrequency electrosurgical generator to coagulate and ablate large surface areas in open abdominal surgical procedures with minimal need for repositioning. The unique shape of the SIRA applicator circumferentially delivers RF energy, yielding reproducible ablation depths.