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Medtronic gets FDA breakthrough tag for device to prevent infections.

Medtronic has received FDA breakthrough designation for a product designed to cut the rate of infections in patients receiving ventricular assist devices. The tag gives the medtech giant added support from agency staff as it winds its way through the regulatory process.

The device is made of the Tyrx bioresorbable polymer mesh technology Medtronic uses to stop infections in patients with implantable electronic devices. Medtronic has repurposed the technology to create a device to address a major source of infection in VAD patients.

Medtronic identified Tyrx as one of the product lines to benefit from COVID-19 on its first quarter results conference call last month. 

With hospitals seeking to minimize rehospitalization during the pandemic, use of Tyrx absorbable antibacterial envelopes increased 9 percentage points sequentially. Half of Medtronic’s U.S. transcatheter pacing and implantable cardioverter defibrillators used Tyrx in the quarter.

The breakthrough designation positions Medtronic to benefit from additional support from FDA as it tries to expand its Tyrx portfolio to VADs. The FDA will engage with Medtronic during development of the device and grant it priority review if the program gets that far. The designation comes shortly after FDA granted breakthrough status to Medtronic’s transcatheter tricuspid valve replacement system.

VADs such as Medtronic’s latest HeartWare devices have improved outcomes in end-stage heart failure patients, with one-year overall survival now topping 80%. However, patients continue to suffer driveline infections.

A significant minority of VAD patients suffer infections related to the driveline that connects implanted heart pumps to external controllers, leading Medtronic to identify the link as a good application for its Tyrx technology.

A paper published earlier this year identified rates of DLIs ranging from 12% to 35% in the medical literature. A separate analysis of data from a Belgium hospital published around the same time found an even higher rate of DLI. Forty-two percent of patients involved in that small study had infections after left VAD implantation.

The health and economic consequences of infection are significant. One analysis put the median cost of readmission to hospital after LVAD at $7,546. DLI was the second most common cause of hospital readmission in the study. Infection is also the second most common cause of death in LVAD patients who are alive six months after treatment.

The Tyrx Absorbable Antibacterial Driveline Wrap is designed to securely hold the percutaneous driveline used to connect external controllers and implanted heart pumps. 

The wrap is made of mesh that releases the antimicrobials minocycline and rifampin. The approved Tyrx Absorbable Antibacterial Envelope, which is made of the same mesh, reduced major infections by 40% in patients receiving cardiac implantable electronic devices. 

Author:Nick Paul Taylor


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