Boston Scientific Receives 510(k) Clearance for Expanded Cryoablation System

Marlborough, MA. (25 August 2023) — Boston Scientific has received 510(k) clearance for expanded indication of the VISUAL ICE cryoablation system. The clearance grants this device an indication expansion to now be used in the treatment of pain associated with tumors that have metastasized to bone in patients who cannot receive standard radiation therapy or if standard radiation therapy has not provided relief.

Boston Scientific is the first company in the USA to receive on-label indication for cryoablation of bone metastases. This, the press release states, is important because cryoablation can offer rapid and durable pain relief for patients who have been taking opioids and non-opioid analgesics or have undergone radiation therapy but still experience severe pain.

“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 of interventional oncology & embolization at Boston Scientific. “As the only company to hold this on-label indication for cryoablation, I am proud that we can help improve quality of life for these patients.”

This indication adds to the wide range of uses for Boston Scientific’s Visual ICE cryoablation system and cryoablation needles, including kidney, liver and lung tissue, prostate cancer, liver metastases, cryoanalgesia, and breast fibroadenomas.