FDA Hits Medtronic's TYRX with Warning Over Anti-Bacterial Envelopes

The FDA sent a warning letter earlier this month to Medtronic (NYSE:MDT) subsidiary Tyrx over problems with its process validation and quality systems.

The Tyrx envelopes are designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days before dissolving over a period of roughly 9 weeks. They’re cleared for use with pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization therapy devices, deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx, which Medtronic acquired for $160 million in January 2014, won CE Mark approval in the European Union for use with cardiac devices in September 2014.

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