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| The Micra leadless pacemaker (right) as compared to a traditional pacemaker--Courtesy of Medtronic |
Medtronic ($MDT) has officially joined the European leadless pacemaker market thanks to the CE mark approval of its Micra Transcatheter Pacing System. It is less than one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.
Medtronic hopes the Micra fares better than St. Jude's ($STJ) leadless Nanostim, which has gotten off to a slow start after it was associated with a few patient deaths. Both devices are implanted in the heart's right ventricle and offer single-chamber pacing.
Leadless pacemakers offer some advantages over the conventional ones that use wires (or leads) to deliver electrical impulses to the heart; Medtronic's device instead delivers electricity via an electrode at the end of the implant.
For one thing, leadless pacemakers are easier to install in the body than their far more common counterparts.
"Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical 'pocket' under the skin, so potential sources of complications are eliminated--as are any visible signs of the device," Dr. Philippe Ritter of Hôpital Cardiologique de Haut Lévêque and Centre Hospitalier Universitaire in France said in a statement.
In addition, the devices eliminate the potential for leads to malfunction. In 2012, St. Jude yanked its QuickFlex and QuickSite pacemaker leads from the market after a few broke through their outer insulation. Both companies have had serious issues with their implantable defibrillator leads, which have caused multiple patient deaths over the years.
Leerink Swann equity analysts Danielle Antalffy and Puneet Souda estimate that leadless pacemakers will earn $700 million in 2016. A dual chambered leadless pacemaker that works on both sides of the heart has the potential to get the vast majority of the $3.5 billion pacemaker market, they say. St. Jude says it is working on such a device.
Meanwhile, Silicon Valley's EBR Systems recently announced a $20 million funding round to support its investigational leadless pacemaker that is implanted in the left ventricle. Funders include an unnamed device company and a former Medtronic president.
Boston Scientific's ($BSX) fast-selling S-ICD has shown the potential of cardiology products that eliminate or lessen the use of leads, albeit in the related but distinct market for implantable defibrillators. Sales of the S-ICD topped $100 million in Q4 2014.
To perform at that level, both Medtronic and St. Jude Medical will need to earn FDA approval for their leadless pacemakers, but that's a few years away. Medtronic inserted the Micra in its first U.S. patient early last year as part of the device's ongoing clinical trial.
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