Medtronic plc Receives CE (Conformité Européenne) Mark for its Cobalt and Crome Portfolio
January 30, 2020 at 09:30 am EST
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Medtronic plc announced it has received CE (Conformité Européenne) 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.
This newest generation of implantable heart devices also includes several “smart” features: 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; and 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 CRT1; reduce unnecessary right ventricular pacing1,2; reduce the likelihood of 30-day heart failure hospital readmissions3; and reduce the risk of atrial fibrillation.4 In addition, AdaptivCRT is associated with improved patient survival.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).