Boston Scientific secures expanded FDA clearance for cryoablation system

The expanded indication adds to an FDA approval for a separate device in Boston Scientific’s cryoablation range.

Robert Barrie August 25 2023

Boston Scientific is continuing its cryoablation market push, as the company secured another US Food and Drug Administration (FDA) win for its cryoablation portfolio – this time an expanded clearance for the company’s VISUAL Ice system.

The 510(k) clearance gives the device an expanded indication for the treatment of pain associated with tumours that have spread to bone where standard therapy has not worked or is not suitable for a patient.

In a statement, Boston Scientific said it is the first company in the US to receive on-label indication for this use.

“Thanks to advancements in cancer treatments, people with cancer are living longer, but that can also mean that many patients living with late-stage cancer may also experience painful bone metastasis,” said Peter Pattison, president, Interventional Oncology & Embolisation at Boston Scientific.

“As the only company to hold this on-label indication for cryoablation, I’m proud that we can help improve quality of life for these patients.”

It is another FDA win for Boston Scientific, who received approval for its POLARx cryoablation system earlier in August.

The approval is predicted to boost the cryoablation segment of the ablation catheters market, analysis by GlobalData says. The segment, which was previously occupied solely by Medtronic, is forecast to reach $738.3m by 2033.

GlobalData medical analyst Aidan Robertson comments: “The rivalry could prove to be beneficial for the market overall, as increased competition translates to better products and services that can meet a more diverse range of needs for patients. Until now, Medtronic has dominated this segment with its Freezor and Artic Front product lines, but now we may see a slight shift in the dynamics of the cryoablation catheter space.”

“The demand for more effective ablation catheters is increasing as the geriatric population continues to grow, which in turn increases the prevalence of cardiovascular diseases. With Boston Scientific launching into the cryoablation catheter segment, we can expect this competition to generate more fine-tuned products and services that can help push the overarching market forward.”

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