News of the regulatory nod comes just weeks after the FDA approved the company’s POLARx cryoablation system for treating paroxysmal AFib.
Clearance grants the device an indication expansion for use in the treatment of pain associated with tumors. These tumors metastasized to bone in patients who can’t receive standard radiation therapy or for whom radiation provides no relief.
This makes Boston Scientific the first company in the U.S. to receive an on-label indication for cryoablation of bone metastases. According to a company spokesperson, this enables cryoablation to offer rapid and durable pain relief for these patients. Such patients take opioids and non-opioid analgesics or undergo radiation therapy but still experience severe pain.
Boston Scientific says the indication adds to a wide array of uses for its Visual Ice cryoablation system and needles. These include kidney, liver and lung tissue, prostate cancer, liver metastases, cryoanalgesia, and breast fibroadenomas.
“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 & Embolization, 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.”
