Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review

Dive Brief:

Medtronic on Monday said a study of its Micra AV leadless, catheter-implanted pacemaker found its algorithms significantly improved cardiac function in patients with atrioventricular (AV) block, a condition marked by impaired electrical signals between the heart’s upper and lower chambers.
The medtech giant said it has submitted the device for FDA approval to expand the indicated patient population to AV block and normal sinus rhythm, based on results from its MARVEL and MARVEL 2 studies. The MARVEL 2 data were published Monday in JACC: Clinical Electrophysiology and are set to be presented Saturday at the American Heart Association annual meeting in Philadelphia.
RBC Capital Markets analysts, in a research note Monday, called Micra AV an important new product for Medtronic's cardiac and vascular group with the potential to address a much larger patient group than is now eligible for the current version of the Micra device.

Dive Insight:

Approved by FDA in 2016 for patients eligible for a single-chamber pacemaker, Medtronic's Micra is the only leadless, transcatheter pacing system on the U.S. market.

Traditional pacemakers are implanted in the upper chest and connected to the heart via leads, which are thin insulated wires. Micra, which Medtronic says is the world's smallest pacemaker at one-tenth the size of a traditional model, is guided directly to the heart through a catheter and attached with small tines.

Medtronic CEO Omar Ishrak has called the device a disruptive innovation that is taking share and expanding the pacemaker market. Looking ahead to launching the Micra AV version, he told analysts on the company's earnings call in August that the new device is "the one product that I’m certainly most excited about."

Michael Coyle, head of Medtronic's cardiac and vascular group, said expanding the potential patient pool for Micra AV to include patients with AV block in normal rhythm boosts the available market for the device to as much as 60% of patients who need ventricular pacing, up from 15% without the indication. He predicted the new device would drive further share gains for the Micra line.

In Medtronic's announcement of the MARVEL 2 study results, co-principal investigator Larry Chinitz of NYU Langone said the device's algorithms can sense signals from the atrium in the heart and calculate adjustments to when ventricular pacing occurs, to improve coordination between the atrium and ventricle.

The study, which met its primary endpoints for safety and effectiveness, evaluated 75 patients implanted with the Micra AV at 12 centers in Hong Kong, Malaysia, Europe and the U.S. Forty patients with complete heart block and normal sinus rhythm were eligible for the primary efficacy analysis, and all 75 patients studied for the safety endpoint had no pauses or episodes of pacing-induced tachycardia.

Medtronic has been planning to launch Micra AV toward the end of its fiscal year 2020, according to RBC Capital Markets analysts, who said the current version of Micra receives three times the reimbursement of a regular pacemaker.