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.

“We continue working towards obtaining additional indications where our novel technology can significantly impact patient care.”

Various long-term clinical studies have shown that RFA of soft tissue could mitigate complications and reoperation rates.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.