ACC 2019 – Medtronic gets a new box of Tyrx


Medtronic needed a win in the Wrap-It study to boost uptake of its Tyrx absorbable antibacterial envelope – and it has one. The trial found that the envelope, when used with implantable cardiac devices like pacemakers, significantly reduced major infection without increasing the risk of complications. Tyrx, which is already widely approved, is a bioresorbable polymer mesh pouch impregnated with the antibiotics minocycline and rifampin. Implantable devices are placed inside the envelope before being put into patients, with the aim of preventing infections. The 7,000-patient Wrap-It trial evaluated whether using Tyrx decreased the incidence of infection leading to device removal or revision, antibiotic therapy with infection recurrence, or death, one year after implantation. 25 patients in the Tyrx group experienced such an event, versus 42 in the control group, who received an implantable device without the envelope. The difference was statistically significant, with a p value of 0.04. Meanwhile Tyrx was non-inferior to control on the safety endpoint, procedure or system-related complications within a year. Medtronic will now have to wait and see if Tyrx will be added to cardiology guidelines, although this seems likely given its potential to reduce hospital readmissions.

The Tyrx envelope

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