Medical device firm Innoblative Designs has secured approval from the US Food and Drug Administration (FDA) for its SIRA RFA electrosurgical device.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
SIRA RFA electrosurgical device is a novel radiofrequency ablation (RFA) applicator, which provides energy for use in electrosurgery.
The next-generation RFA applicator has been designed specifically for intraoperative coagulation and ablation of soft tissue.
Stanford University School of Medicine surgery associate professor Dr Brendan Visser said: “The design of the SIRA applicator makes it uniquely suited to ablate large surface areas.
“The large spherical applicator minimizes subjective repositioning of the device, leading to a more controllable and predictable ablation performance.”
Radiofrequency ablation of soft tissue has been demonstrated to reduce complications and reoperations in multiple long-term clinical studies, said the company.
SIRA RFA device, along with a radiofrequency electrosurgical generator, will help coagulate and ablate large surface areas in open abdominal surgical procedures with minimal need for repositioning.
The unique shape of the SIRA applicator facilitates to circumferentially deliver RF energy, enabling to achieve reproducible ablation depths.
SIRA RFA is provided with a 4cm diameter spherical electrode for the creation of a wide ablation zone, helping to cover a larger surface area per ablation. It safely enables complete and accurate ablation of clinical target.
The larger applicator helps to avoid painting a tissue surface, while physician-controlled settings allow to customize ideal ablation performance.
Innoblative Designs CEO and co-founder Tyler Wanke said: “Receiving FDA clearance is a significant milestone for Innoblative, and we look forward to commercializing the SIRA device in the US market.
“With our initial indication in hand, we continue working towards obtaining additional indications where our novel technology can significantly impact patient care.”
As per statistics of the World Health Organization (WHO), around 13% of the global population suffers from cancer and it is expected to increase by around 70% over the next few decades.
Innoblative Designs is involved in the development of next generation and advanced-energy surgical solutions to help surgeons better coagulate and ablate soft tissue.