EU Clears Medtronic’s Smart Cobalt and Crome Cardiac Implants

Medtronic has announced that its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D) won EU CE Mark clearance, allowing their introduction to the continent.

The devices feature Medtronic’s OptiVol fluid status sensors that allow the introduction of the company’s new TriageHF technology. This classifies patients into one of three groups for potential for heart failure (high, medium, low) based on measures including heart rate variability, atrial fibrillation, and fluid status. Medtronic also announced that existing devices with the OptiVol feature, including those already implanted into patients, can now take advantage of TriageHF.

“Cobalt and Crome heart devices deliver the opportunity of a personalized approach to defibrillator therapy, demonstrating how far we have come in this field,” said Klaus Witte, M.D., of the School of Medicine, University of Leeds, UK, in a Medtronic press release. “Moreover, these devices offer seamless patient care through their ability to transmit device and patient data via smartphone or tablet.”


Here are some of the other features within the new Cobalt and Crome implants, according to Medtronic:

• Intrinsic ATP™ (iATP), available on Cobalt XT ICDs and CRT-Ds, is the only automated algorithm that adapts to a patient’s irregular heart rhythms and attempts to reset them with painless pacing therapy, possibly avoiding the need for shocks. This ventricular anti-tachycardia pacing (ATP) provides individualized therapy in real-time and is paired with Medtronic-exclusive SmartShock™ 2.0 shock-reduction technology. The devices also feature improved longevity and energy output.
• This is the first Medtronic ICD and CRT-D portfolio to offer connected health with BlueSync™ Technology, which enables the implanted devices to communicate with the tablet-based CareLink SmartSync™ Device Manager for physicians, and the MyCareLink Heart™ mobile app for patients.
• The new CRT-Ds also include the EffectivCRT™ algorithm and the AdaptivCRT™ algorithm, which adjusts therapy according to minute-by-minute evaluations of each patient’s heart rhythm. AdaptivCRT has been shown to increase patients’ response to CRT; reduce unnecessary right ventricular pacing; reduce the likelihood of 30-day heart failure hospital readmissions; and reduce the risk of atrial fibrillation. In addition, AdaptivCRT is associated with improved patient survival.

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