Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs

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Cobalt XT DR ICD MRI SureScan DF4

Medtronic has received US Food and Drug Administration (FDA) approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D).

ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals with heart failure, send small electrical impulses to the lower chambers of the heart to help them beat in more synchronised patterns and reduce patient symptoms.

In a press release, Medtronic said that these were its first “high power” devices to offer connected health, including the ability for clinicians to programme them 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.

CareAlerts: 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.

Intrinsic ATP: Intrinsic ATP (anti-tachycardia pacing) gives patients individualised therapy in real-time, with devices automatically adapting to a patient’s abnormally fast heart rhythms (ventricular tachycardia) and attempting to terminate them with painless pacing therapy, possibly avoiding the need for shocks and their associated hospitalisations.

The Cobalt and Crome devices received CE mark approval in January 2020.


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