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Health Canada approves radiopaque bead for HCC, CRC liver metastases

BTG International Canada Inc. announced it received approval for its drug-eluding device, the DC Bead LUMI, from Health Canada. The bead is the first commercially available product for patients with hepatocellular carcinoma and colorectal cancer metastasized to the liver.

DC Bead LUMI (BTG International) are radiopaque beads that can be loaded with doxorubicin or irinotecan and then implanted in patients to treat local tumors. This enables radiologists to follow them in real-time, according to a press release.

“DC Beam LUMI reinforces our leadership in embolization technology and our focus on bringing to market innovative products that better serve specialist physicians and their patients,” Brad Pearson, director of commercial operations at BTG International, said in the release. “We are excited by the potential to offer a new standard of care and look forward to providing DC Bead LUMI to Canadian physicians during the second half of 2016.”

The FDA granted 510K clearance to an adaptation of DC Bead LUMI — the LC Bead LUMI — in December 2015. This version was used in February for the first time to treat a patient with liver cancer and then released in the U.S. two months later.

Raj Narayanan, MD, associate professor of clinical radiology at the University of Miami, said in a separate release that the launch of the LC Bead LUMI could be a “game-changer” for embolization.

“Not only does it provide doctors and patients with reassurance that the tumor has been treated in its entirety, but it allows interventional radiologists like me to refine treatment as we go, with the subsequent prospect of improved outcomes for patients,” Narayanan said.

BTG International anticipates securing regulatory clearances for additional bead products in other markets worldwide, according to the release.

Disclosure:  Pearson is employed by BTG International Canada Inc. Healio.com/Hepatology could not confirm Narayanan’s financial disclosures at the time of publication.

Editor's note: This item was updated with a quote from Narayanan and to provide more product background.