FDA Approves Medtronic Cobalt and Crome ICD Portfolio

May 12, 2020 — Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D),the first Medtronic “high power” devices to offer connected health, including the ability for clinicians to program devices from a physical distance,thereby reducing potential exposure to the virus that causes COVID-19.

The devices use the MyCareLinkHeart mobile app, along with other exclusive features including:
   •  TriageHF Heart Failure Risk Status: TriageHF automatically provides patients’ heart failure risk assessments to clinicians and identifies changes that may lead to worsening heart failure. It evaluates multiple factors that can lead to hospitalization such as heart rate variability, atrial fibrillation and fluid status, and it is compatible with all Medtronic ICDs and CRT-Ds with the Medtronic OptiVol fluid status monitoring feature, including those currently implanted in patients.
   • CareAlerts: New CareAlert notifications help physicians manage clinically relevant events and direct their attention to patients who need it most, potentially before patients need in-office care. Clinicians can opt to receive CareAlerts via text email and/or voicemail.

For more information: www.medtronic.com