Will Neuro FDA Clearance for Medtronic's TYRX Envelope Lead to More Risk Sharing?

Marie Thibault

Earlier this month, Medtronic announced FDA clearance of the TYRX Neuro Absorbable Antibacterial Envelope to be used with implantable neurostimulators (INS). 

The product, a mesh envelope into which INS or cardiac implantable electronic devices (CIEDs) are placed, is part of Medtronic's Infection Control business, which is committed to reducing surgical site infections and implant-related inflammation. 

This is the second FDA clearance for the TYRX Envelope. The first, back in July 2013, approved use with pacemakers and ICDs. The Envelope works by releasing minocycline and rifampin antimicrobials over at least a week to prevent infections at the implant site. The Envelope is fully absorbed about nine weeks after being placed. 

Earlier this year, Medtronic announced that the TYRX Envelope was the basis of a risk-sharing contract with a U.S. hospital. As MD+DI's Arundhati Parmar reported, the agreement aligned Medtronic's interests with the hospital's efforts to reduce infection following implants.   

Will Medtronic enter into similar agreements for the neurostimulator application of the TYRX Envelope? That remains to be seen.

The company said, in a statement from a spokesperson, “We are currently working to evaluate and vet various risk-based models in the Neuro space. We do not currently have a program in place, but we look forward to working with our customers to create value-based solutions specific to the Neuro market over the coming months.”

The new FDA clearance covers INS devices, which include stimulators for the deep brain, sacral nerve, spinal cord, and vagus nerve. According to a Medtronic press release about the clearance, the TYRX Envelope is available commercially for use with all deep brain stimulation (DBS) systems, and is anticipated to be available in coming months for use with INS for chronic pain, bladder control, and bowel control disorders. 

The TYRX Envelope has already been used with Medtronic's DBS systems in implants by Francisco Ponce, MD, director of the Barrow Center for Neuromodulation at Phoenix's Barrow Neurological Institute. 

"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," Ponce said in the company press release. "I am excited about this technology and the potential clinical and economic benefits it may offer our patients, our practice, and the healthcare system," he added.

Rebecca Seidel, general manager of Medtronic's Infection Control business, said in the release, “Extensive data has been collected on the clinical efficacy and economic value of the TYRX antibacterial envelope with implanted cardiac devices, and we are now pleased the envelope can be used for patients receiving neuromodulation devices, including those for deep brain stimulation."
 

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Images courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET and MEDTRONIC PLC]