Therapy Areas: Devices
Innoblative Designs Inc passes US FDA approval for SIRA RFA Electrosurgical Device use in electrosurgery ablation
10 April 2019 -

Medical device company Innoblative Designs Inc disclosed on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for its SIRA RFA Electrosurgical Device for ablation procedures in electrosurgery.

According to the company, the SIRA RFA Electrosurgical Device is a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.

The company added that the radiofrequency ablation of soft tissue has been shown in multiple long-term clinical studies to reduce complications and reoperations. However, current conventional RF applicators are not optimised to treat large surface areas, which can lead to long procedure times and variable ablation depths.

Concurrently, the company'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 SIRA applicator circumferentially delivers RF energy, yielding reproducible ablation depths.

Additionally, the increase in prevalence of cancer is a major factor contributing to ablation procedures market growth. Based on statistics published by the World Health Organization, 13% of the global population suffers from cancer and it is expected to rise by approximately 70% over the next few decades, concluded the company.



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