Devices & Diagnostics

Medtronic, St. Jude benefit from Boston Scientific woes

Two relatively minor manufacturing process changes may have been responsible for Boston Scientific Corp.’s (NYSE:BSX) decision to pull its entire inventory of implantable cardiac defibrillators and cardiac resynchronization therapy devices, according to healthcare analysts at Leerink Swann. The New York-based investment bank, quoting a physician who spoke with BSX sales representatives, said the shipment hold […]

Two relatively minor manufacturing process changes may have been responsible for Boston Scientific Corp.’s (NYSE:BSX) decision to pull its entire inventory of implantable cardiac defibrillators and cardiac resynchronization therapy devices, according to healthcare analysts at Leerink Swann.

The New York-based investment bank, quoting a physician who spoke with BSX sales representatives, said the shipment hold last week was caused by two issues. First, the company failed to inform the Food & Drug Administration that it had added a supplier for one of its ICD components; and second, it had changed a process (possibly a cleaning process) to make it identical to a process for its pacemaker devices, according to the un-named physician.

But additional details were still very difficult to come by, including specifics on the exact cause of the de-facto recall. The company has remained silent on the issue since the initial announcement.

Leerink is quoting the same physician as saying that, assuming Boston Scientific gets back on its feet within its 30-day deadline, it will still take a good three to six months to return to pre-shipment hold levels. BSX arch-rivals Medtronic Inc. (NYSE:MDT) and St. Jude Medical (NYSE:STJ) are already seeing a lot of additional business while Boston Scientific sits on the bench, with Minneapolis-based Medtronic pulling in about two-thirds of that business.

The revelations came from the investment bank’s Analyst Pulse conference call, featuring remarks from “a high-volume U.S. electrophysiologist.”

Last week, the FDA issued a statement on the recall, saying that Boston Scientific informed the watchdog agency that it will submit a pre-market approval supplement for the changes. The agency said it hadn’t received any reports of injuries caused by the action.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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