FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

TGA Issues Warning, Halts Study on St. Jude Medical Nanostim Leadless Pacemaker

Jan. 9, 2017

Australia’s TGA has issued a warning and halted a clinical study of St. Jude Medical’s Nanostim leadless cardiac pacemakers due to battery malfunctions.

The pacemakers were implanted in 22 Australian patients as part of the Nanostim Leadless II IDE/CAP clinical study, which has been halted.  The company reported that 0.5 percent of the implanted Nanostim leadless cardiac pacemakers have experienced battery malfunction.

The study was being conducted at 56 centers in the U.S., Canada and Australia. To date, 1,423 devices have been implanted worldwide, according to St. Jude Medical. — Tamra Sami

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