Medtronic (NYSE:MDT) announced today that it has received the CE Mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization 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 synchronized patterns and reduce patient symptoms.
“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 Dr. Klaus Witte of the School of Medicine, University of Leeds, UK, in a news release from Medtronic. “Moreover, these devices offer seamless patient care through their ability to transmit device and patient data via smartphone or tablet.”
The Cobalt and Crome platform includes Medtronic’s TriageHF technology, which the company describes as a simplified, integrated, automatic tool that identifies patient status changes that may lead to worsening heart failure and hospitalization. TriageHF stratifies patients into three risk categories (high, medium or low) by evaluating factors such as heart rate variability, atrial fibrillation and fluid status. TriageHF is compatible with all Medtronic ICDs and CRT-Ds with the Medtronic OptiVol fluid status monitoring feature, including those currently implanted in patients.
The company also said it included several “smart” features in its new implants:
- 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 individualized therapy in real-time and is paired with Medtronic’s SmartShock 2.0 shock-reduction technology. The devices also feature improved longevity and energy output.
- 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 EffectivCRT and AdaptivCRT algorithms, available on the new CRT-Ds to adjust 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 pacing1,2; reduce the likelihood of 30-day heart failure hospital readmissions; and reduce the risk of atrial fibrillation, according to studies cited by Medtronic. AdaptivCRT is associated with improved patient survival, the company said.
“The Cobalt and Crome devices demonstrate our commitment to enhancing device connectivity and personalized patient care,” said Dr. Rob Kowal, chief medical officer of Medtronic’s cardiac rhythm and heart failure division. “These advancements will help physicians respond to patients’ individual needs through informed clinical decision-making, potentially improving the outcomes of patients around the world.”