Fierce Biotech February 23, 2023
In an April 2022 recall notice, Medtronic asked that all unused Harmony TPV delivery catheters be returned and that all planned procedures with the system be put on hold. Those procedures can now begin again, as the company “worked collaboratively with the FDA to remediate the issue and earn FDA approval to return the device to market,” it announced this week. (Getty Images)
Nearly a year after recalling a crucial component of its Harmony transcatheter pulmonary valve (TPV) system—a process that began barely a year into the device’s initial rollout—Medtronic is striking the right note.
The medtech giant has begun a relaunch of the heart valve, it announced Wednesday, making the Harmony system once again available...
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