Medtronic (NYSE:MDT) said today that Japanese regulators approved its Micra leadless pacemaker, which it claims as the world’s smallest pacemaker.
At 1/10th the size of a conventional pacemaker, or roughly the size of a large vitamin, Micra is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing. The device has an estimated 12-year battery life and is approved for full-body MRI scans. The FDA approved Micra in April 2016.
Medtronic said the approval from Japan’s Pharmaceuticals & Medical Device Agency was based on its single-arm, 744-patient Micra TPS study at 56 centers in 19 countries including Japan.
“Medtronic is excited to be the first to offer a miniaturized, leadless pacemaker to patients in Japan,” cardiac rhythm & heart failure president Dr. John Liddicoat said in prepared remarks. “We look forward to working with Japan’s Ministry of Health, Labor & Welfare to gain reimbursement for Micra so patients can gain access to this innovative technology as quickly as possible.”
“The development of a leadless pacemaker which can be implanted with a less invasive procedure has been eagerly awaited by physicians and patients in Japan,” added Dr. Kyoko Soejima of Kyorin University. “The safety and efficacy of the Micra TPS has been confirmed in my hospital as well as in other hospitals across the world that took part in the Micra TPS global clinical trial.”
Although it’s designed to be retrievable, Micra can be left in the body and permanently deactivated so a new device can be implanted if needed. Twelve-month data released at the annual meeting of the European Society of Cardiology in Rome last year showed a 96% freedom-from-complication rate and a 48% lower risk of major complications.
Last month the U.S. Centers for Medicare & Medicaid Services released a National Coverage Determination for leadless cardiac pacemakers, meaning Medicare and Medicaid patients will have access to coverage for Micra implantations.