Medtronic warns doctors of potential issues with the EnVeo R delivery system
Medtronic sent a warning letter to doctors alerting them to proceed with caution when using the minimally invasive EnVeo R delivery system, the Star Tribune reports. The newspaper noted that Medtronic voluntarily updated instructions for using the system after reports emerged of 19 patients dying from severe blood vessel trauma.
The EnVeo R delivery system is used to implant the Evolut R transcatheter aortic valve replacement system in the heart of patients with severe aortic stenosis.
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