Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch sometime this spring.

About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired.

Patients with AV block historically have been fitted with dual-chamber pacemakers, which are implanted just beneath the skin below the collarbone and connected by wires to the heart. By contrast, Medtronic’s Micra technology requires neither leads nor a berth below the skin, reducing the risk of complications.

“Although complications with traditional pacemakers are infrequent, when they occur, they’re expensive to treat and can be invasive for the patient,” said Larry Chinitz, cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center. “Real-world use of Micra has shown a 63% reduction in major complications compared to traditional pacemakers.”

Identical to Medtronic’s original Micra Transcatheter Pacing System (TPS) in size and shape, the Micra AV is beefed up with more internal atrial sensing algorithms, which enable it to adjust and synchronize pacing in the heart’s upper and lower chambers.

MARVEL 2 results

Micra AV device. Credit: Medtronic plc

The FDA based its approval on the MARVEL 2 study, which assessed the ability of an investigational set of algorithms in the Micra TPS to monitor and detect atrial contractions and coordinate pacing in the atrium and ventricle. The study met its primary endpoint, with a significantly greater share of complete heart block patients with normal sinus rhythm having better than 70% AV synchrony during algorithm-mediated AV synchronous pacing vs. single-chamber ventricular (VVI) pacing (38 of 40 patients vs. 0 patients). The primary safety objective was also met, with no pauses or episodes of pacing-induced tachycardia reported during algorithm-mediated AV synchronous pacing. The results were published in November in JACC: Clinical Electrophysiology.

With FDA approval of Micra AV, Medtronic now boasts the first and only leadless pacemaker portfolio available in the U.S.

The timing of the FDA nod beat company expectations by about three months. During the J.P. Morgan Healthcare Conference in San Francisco last week, Omar Ishrak, Medtronic’s chairman and CEO, predicted the agency would approve the Micra AV by the end of the current fiscal year, which ends in late April. The Micra AV is expected boost the patient pool for the existing Micra VR, which launched in 2016, from 15% of pacemaker patients to about 55%, he said.

“Since revolutionizing medicine with the first battery-powered cardiac pacemakers, Medtronic has continued to develop pioneering pacing technologies, culminating in the first miniaturized, leadless pacing portfolio for physicians and their patients,” said Rob Kowal, chief medical officer and vice president of medical affairs in the cardiac rhythm and heart failure division of Medtronic’s cardiac and vascular group (CVG). “The introduction of Micra AV reinvents our own innovation, bringing the many benefits of leadless pacemakers to more patients.”

Revenue bump

With its potential to triple Micra’s eligible population, the Micra AV could reap real revenue benefits for Medtronic, both in terms of mix and market share gains, according to Wells Fargo analyst Larry Biegelsen.

“We estimate Micra VR has helped MDT capture about 500 bps of share in the U.S. pacemaker market since its launch in 2016,” he wrote in a research note. “Based on the success of Micra VR, we estimate Micra AV could contribute incremental revenue of $100M to MDT in F2021 and FY2022 or roughly 30 bps to total MDT growth.”

Biegelsen added that Medtronic anticipates Micra AV fueling double-digit growth in pacing sales, “so there is likely upside potential to our numbers when Micra AV is launched.”

Medtronic said it will start training doctors and field personnel on the newest Micra pacemaker and greenlight a handful of implanting centers within weeks.

For the second quarter of FY 2020, ended Oct. 25, 2019, Medtronic saw grow 3% year over year to $7.71 billion. CVG contributed $2.86 billion to the total, with mid-single-digit growth in pacemakers propelled by strength of Micra TPS.

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