The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs’ electrosurgical device SIRA RFA.
This radiofrequency ablation (RFA) applicator is designed to remove dysfunctional soft tissue using heat generated from a medium-frequency alternating current.
SIRA RFA features a 4cm-diameter spherical electrode, which creates a wide ablation zone that covers a large surface area per ablation. It is claimed to safely facilitate accurate removal of clinical targets.
SIRA’s spherical design is claimed to minimise subjective repositioning and enable more controlled and predictable tissue removal. Its unique shape allows circumferential delivery of radiofrequency (RF) energy and enables reproducible ablation depths.
Various long-term clinical studies have shown that RFA of soft tissue could mitigate complications and reoperation rates.
When combined with a radiofrequency electrosurgical generator, SIRA RFA is expected to help coagulate and ablate large surface areas in open abdominal surgical procedures.
Innoblative Designs CEO and co-founder Tyler Wanke said: “Receiving FDA clearance is a significant milestone for Innoblative, and we look forward to commercialising 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.”
Statistics by the World Health Organization (WHO) revealed that 13% of the global population developed cancer in 2013. This figure is predicted to increase by around 45% by 2030.