MSAC to consider innovative leap in pacemaker technology

MedTech News: An application for the world’s smallest leadless pacemaker is scheduled to be considered at the July Medical Services Advisory Committee (MSAC) meeting.

Medtronic’s Micra Transcatheter Pacing System (TPS) is a leadless pacemaker for patients with bradycardia – a single-chamber implantable transcatheter pacemaker inserted via the femoral vein and implanted directly into the right ventricular myocardium negating the need for transvenous wires.

By virtue of its design, this pacemaker has the potential to reduce lead and pocket-related complications, two major drawbacks of traditional transvenous pacemakers.

In a recently published real-world study, the Micra leadless pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous pacemaker. However, there were higher rates of pericardial effusion and/or perforation with the Micra leadless pacemaker. There was no difference in adjusted all-cause mortality at 2 years.

Hence, the clinical claim made in the MSAC application is that, relative to standard single-chamber transvenous pacemakers, the transcatheter leadless pacemaker is noninferior in terms of effectiveness and superior in terms of overall safety.

No leadless pacemakers were available on the 1 July 2022 Prostheses List (PL). Medtronic intends to submit an application this year to include the Micra TPS on the PL.

While Medtronic remains the only company with TGA approval for a leadless pacemaker, both Boston Scientific and Abbott are racing to bring competing devices to the global market.

Earlier this year, Medtronic also received approval in Japan for the sale and reimbursement of Micra TPS.