Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.
Meanwhile, the Dublin-based company has applied for U.S. FDA approval of the Cobalt and Crome devices and anticipates approval in the coming months, Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division, part of Medtronic’s Cardiac and Vascular Group, told BioWorld.
Chock full of ‘smart’ technologies
The next-generation portfolio is comprised of Cobalt XT single- and dual-chamber ICDs and CRT-Ds, Cobalt single- and dual-chamber ICDs and CRT-Ds and Crome single- and dual-chamber ICDs and CRT-Ds. Among its “smart” technology enhancements are Bluesync, Triage HF Intrinsic ATP.
“The Cobalt and Crome devices demonstrate our commitment to enhancing device connectivity and personalized patient care,” Kowal said. “These advancements will help physicians respond to patients’ individual needs through informed clinical decisionmaking, potentially improving the outcomes of patients around the world.”
Developed by Medtronic, Bluesync enables implanted devices to communicate securely to the company’s Carelink Network – the tablet-based Carelink Smartsync device manager for doctors and Mycarelink Heart mobile app for patients – via the use of Bluetooth Low Energy.
The TriageHF technology assesses a patient’s risk of heart failure by evaluating factors such as heart rate variability, atrial fibrillation and fluid status and stratifies them into three risk categories: high, medium and low. It is compatible with all Medtronic ICDs and CRT-Ds that monitor fluid status with Optivol, including currently implanted devices.
The new Cobalt XT ICDs and CRT-Ds also include Intrinsic ATP (iATP), the only automated ventricular anti-tachycardia pacing algorithm that adapts to a patient’s rapid heart rhythms and attempts to reset them with painless pacing therapy. That feature could be a big boon for patients, according to Kowal, who said anxiety from shocks not only impacts patients’ quality of life and daily activities but can lead to unnecessary hospital admissions. He noted that Medtronic’s Smartshock technology already reduces the incidence of inappropriate shocks.
“All manufacturers have ventricular ATP. However, if today’s ATP fails to terminate a rhythm, it simply goes on to deliver the next programmed therapy (could be more ATP, or advance to deliver a shock),” Kowal said. “Intrinsic ATP is unique in that it analyzes the previous sequence to determine why it was not successful and uses that information to adapt the next ATP sequence in real time.”
Finally, the new CRT-Ds include the EffectiveCRT and AdaptivCRT algorithms, which adjust therapy continuously based on detection of real-time fluctuations in heart rhythm.
To support its CE mark application, Medtronic submitted bench testing as well as data collected in an FDA-approved IDE clinical feasibility study.
The Cobalt and Crome devices are the latest in a string of approvals for Medtronic’s Cardiac and Vascular Group. In November, the company won the FDA’s nod for its In.Pact AV (arteriovenous) drug-coated balloon, the second application for is In.Pact DCB platform. And last week, the agency greenlighted its Micra AV, the world’s tiniest pacemaker with atrioventricular synchrony.
During a fiscal year second-quarter earnings call in November, Michael Coyle, executive vice president and group president of the Cardiac and Vascular Group, was enthusiastic about group’s prospects in the year ahead. “We … have the headwinds associated with the replacement cycle in especially pacemakers and in CRT-D devices, that has begun to mitigate. And even though we still see pressure in the traditional ICD segment, CRT-D is the biggest single replacement component of our market, and obviously pacemakers are a big component as well,” he said. “So whereas we’ve had the last couple of years of very significant headwinds, as we head into FY ’21, we are beginning to see that turn into a neutral impact on our overall growth market – or growth trends, which then allows us to see the benefits of the new products that are coming into the market.”