Medtronic receives CE Mark for defibrillators portfolio
Medtronic has received CE Mark for its Cobalt and Crome portfolio of 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.
Klaus Witte, from the University of Leeds’ School of Medicine, said: “Cobalt and Crome heart devices deliver the opportunity of a personalised approach to defibrillator therapy, demonstrating how far we have come in this field. Moreover, these devices offer seamless patient care through their ability to transmit device and patient data via smartphone or tablet.”
With the launch of the Cobalt and Crome platform, Medtronic is making TriageHF technology available. This technology assesses patients’ heart failure risk through a tool that identifies patient status changes that may lead to worsening heart failure and hospitalisation. TriageHF stratifies patients into three risk categories (high, medium or low) by evaluating factors such as heart rate variability, atrial fibrillation and fluid status. The TriageHF assessment tool is compatible with all Medtronic ICDs and CRT-Ds with the Medtronic OptiVol fluid status monitoring feature, including those currently implanted in patients.
The heart devices also includes several “smart” features:
- Intrinsic ATP (iATP), available on Cobalt XT ICDs and CRT-Ds, is an 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 individualised 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.
- The portfolio offers 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 include the EffectivCRT algorithm and the AdaptivCRT algorithm, which adjusts therapy according to minute-by-minute evaluations of each patient’s heart rhythm.
Rob Kowal, chief medical offer of the cardiac rhythm and heart failure division at Medtronic, said: “The Cobalt and Crome devices demonstrate our commitment to enhancing device connectivity and personalised patient care. These advancements will help physicians respond to patients’ individual needs through informed clinical decision making, potentially improving the outcomes of patients around the world.”
The Medtronic portfolio of therapies, diagnostic tools and services for patients suffering from heart failure includes ICD and CRT devices, including MR-conditional ICDs, CRT-Ds and CRT-pacemakers; mechanical circulatory support therapy for advanced heart failure patients; and heart failure diagnostics.