 |
| The Micra leadless pacemaker (right) as compared to a traditional pacemaker--Courtesy of Medtronic |
The leadless pacemaker market is one to keep an eye on over the next decade or so, says Bloomberg. Traditional ones are already worth more than $3 billion per year.
The benefits of the newer devices are numerous, and there are now two leadless pacemakers available in Europe made by St. Jude Medical ($STJ) and Medtronic ($MDT), with a third one planned from Boston Scientific ($BSX). St. Jude's earned a CE mark in 2013, but has stumbled after two patients died and 6 developed holes in their hearts. Bloomberg reports that the company restarted implantation of the device last month.
Medtronic's Micra hasn't suffered from major safety concerns (though it only earned a CE mark last month), and has "leapfrogged" St. Jude's Nanostim, the article says.
The dangers of leads (or wires that usually connect to the heart) are well known (both Medtronic and St. Jude have suffered numerous lawsuits over their failed leads), but a less appreciated benefit is the leadless device's ease of implantation.
Because leadless pacemakers are one-tenth the size of traditional ones, they can be implanted through the groin via a catheter. Bloomberg points out that in India, there are fewer than 100 electrophysiologists, but more than 1,000 interventional cardiologists who are qualified to insert leadless pacers.
St. Jude plans to file for FDA approval of the Nanostim by the end of the year, but those gnarly safety issues could get in the way. Bloomberg says swelling at the site of the implant and dislodgement of the pacemaker have been observed in the FDA trials.
Meanwhile, Medtronic's FDA trial for the Micra completed enrollment early. The company aims to file for approval next year.
Leadless pacemakers seemingly quality for the FDA's optional, new Expedited Access Pathway for critical medical devices, meaning approval could occur faster than expected if the agency allows shorter, smaller trials.
Boston Scientific's 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.
The company recently revealed its program to develop a leadless pacemaker: "While on the one hand, we see that leadless pacing may be interesting for a small niche of patients who just need single-chamber pacemakers, actually to us the bigger opportunity is pairing it with the S-ICD, so that if you have patients who need defibrillators but who also need pacing, or also need anti-tachycardia pacing, now they've got a full, comprehensive option for anti-tachycardia pacing or back up VVI pacing," said Boston Scientific senior vice president Dr. Ken Stein at a recent conference.
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. Bloomberg says all three industry players are trying to add wireless communication capabilities to the devices in an attempt to pace multiple chambers.
- read the article in Bloomberg