Medtronic Announces Data From HRS 2020; Receives FDA Approval of Cobalt and Crome ICD and CRT-D

May 8, 2020—The company announced that results from late-breaking clinical trials evaluating the MyCareLink Heart (MCLH) mobile app and the Micra transcatheter pacing system (TPS) were presented at HRS 2020 Science, the annual Heart Rhythm Society Scientific Sessions being held virtually because of the COVID-19 pandemic.

MCLH is a remote monitoring application. Compatible with Medtronic BlueSync technology-enabled cardiac devices, the MCLH mobile app is designed to securely and wirelessly send cardiac device data to the Medtronic CareLink network via a patient-owned phone or tablet.

The Micra TPS leadless pacemaker, which was approved by the FDA in 2016 and is available globally, does not require leads or a surgical “pocket” under the skin.

Additionally, Medtronic announced FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D). The Cobalt and Crome ICD and CRT-D are “high power” devices that offer connected health, including the ability for clinicians to program devices from a physical distance. The devices use the MCLH mobile app, along with other features including TriageHF, which automatically provides patients’ heart failure risk assessments to clinicians and identifies changes that may lead to worsening heart failure; CareAlerts notifications that help physicians manage clinically relevant events and direct their attention to patients who need it most; and Intrinsic ATP, which is antitachycardia pacing that gives patients individualized therapy in real-time.

At HRS 2020 Science, results from the BlueSync Field Evaluation study demonstrated that patients who used the Medtronic MCLH were more likely to adhere to their pacemaker remote monitoring schedule than patients who used traditional bedside monitors. The BlueSync Field Evaluation was a prospective, multicenter study measuring the success rate of scheduled transmissions in pacemaker patients using the MCLH mobile app for 12 months. Scheduled transmission success was compared to three distinct groups of bedside monitor device users from the Medtronic deidentified CareLink database.

The study found that patients using the MCLH technology successfully completed 94.6% of scheduled transmissions, which was superior to all three Medtronic bedside monitor control groups (whose results ranged from 56.3% to 87.1%).

Higher patient adherence to scheduled transmissions of remote monitoring suggests that patients who use the MCLH app are more likely to benefit from remote monitoring than those with low or no adherence to remote monitoring, noted the company.

The Micra CED study evaluated device performance in 5,746 Medicare patients implanted with a Micra TPS and 9,662 Medicare patients implanted with a traditional transvenous VVI pacemaker (TV-VVI, regardless of manufacturer) using claims data from the Centers for Medicare & Medicaid Services.

Results from the Micra CED study showed that patients implanted with a Micra TPS experienced a 66% reduction in chronic complications at 6 months compared with patients who received a TV-VVI. These results provide the first insight into the real-world comparative effectiveness of Micra TPS in the Medicare population.

Along with a significant reduction in complication rates, Micra TPS patients also had a reduction in the rate of device revision compared with patients implanted with a TV-VVI device.

Medtronic advised that although event rates are low, cardiac effusion and/or perforation within 30 days was higher among Micra TPS patients than transvenous patients in both unadjusted (0.8% vs 0.4%; P < .001) and adjusted (0.8% vs 0.4%; P = .002) models; however, results were consistent with findings from the Micra TPS investigational device exemption study and postapproval registry.

“These results show that Micra’s lower likelihood of complications in earlier clinical trials is being maintained in real-world practice,” commented Jonathan P. Piccini, MD, in Medtronic’s press release. Dr. Piccini is Associate Professor of Medicine and Director of Cardiac Electrophysiology at Duke University Medical Center in Durham, North Carolina.