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April 11, 2019

FDA approves Innoblative’s radiofrequency ablation device

The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs’ electrosurgical device SIRA RFA.

The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs’ electrosurgical device SIRA RFA.

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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.

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.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

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