Medtronic (NYSE:MDT) said today that it’s launching its Tyrx surgical envelope in the U.S. for use with deep-brain stimulation devices, after it won 510(k) clearance from the FDA for use of the infection-fighting envelope with implantable neurostimulators.
Fridley, Minn.-based Medtronic said it’s planning to make the Tyrx device, acquired for $160 million in January 2014, available for other neurostim indications “in the coming months.”
The device is designed to elute a pair of anti-microbial drugs, minocycline and rifampin, for 7 days. The envelope is designed to then dissolve over a period of roughly 9 weeks.
“The Tyrx Neuro absorbable antibacterial envelope is a much needed and long awaited solution to the risk of infection related to implantable neurostimulators. It is going to be the standard of care in my practice,”Dr. Francisco Ponce of the Barrow Neurological Institute in Phoenix, who performed the 1st DBS implantations with the Tyrx envelope, said in prepared remarks. “I am excited about this technology and the potential clinical and economic benefits it may offer our patients, our practice, and the healthcare system.”
“Medtronic is committed to providing technologies that improve patient outcomes,” added Medtronic brain modulation general manager Lothar Krinke. “Reducing the risk of infection is very important as patients and their physicians consider DBS as a treatment option.”
Medtronic said the Tyrx envelope is FDA-cleared for use with pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, and with deep-brain stimulators, sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. It won CE Mark approval in the European Union for cardiac devices in September 2014.