Medtronic sets the pace with Micra approval

Not a great deal is going right for St. Jude Medical at the moment. Despite being first to get a leadless pacemaker, Nanostim, to the European market it has been beaten to the US by its arch-rival Medtronic, whose catheter-mounted Micra pacer became the first such device approved by the FDA yesterday, several months ahead of expectations.

Pacemaker development is not an area of white-hot innovation, and none of the companies active here see steep sales growth for their devices. Even so, St. Jude’s performance has been disappointing, with the company’s cardiac rhythm management unit falling behind its peers. Its pacemaker sales are forecast to shrink at an annual rate of 2% to 2020, whereas Medtronic’s are growing. And every day Micra – but not Nanostim – is available in the US reinforces the disparity.

Rhythm management is more important for St. Jude than it is for Medtronic. At just over $1bn, St. Jude’s pacemaker sales make up nearly 20% of its overall revenues, but Medtronic, though it makes twice as much from pacemakers, is a vastly larger company so its pacemaker unit only accounts for around 10% of its turnover.

Two-horse race

Leadless pacemakers are implanted via catheters directly into the right ventricle. They do away with the wires used to link traditional pacemakers, implanted in the chest, to the heart muscle. These leads can break or become infected, so leadless pacemakers are less prone to complications.

Other companies, notably Boston Scientific, are working on leadless pacemakers but St. Jude and Medtronic are way out in front. The FDA’s approval decision for both Micra and Nanostim was expected at roughly the same time – late 2016 or early 2017. Micra has arrived early, and St. Jude can only wait.

While it is tricky to say which of the devices is superior as they have not been tested in a head-to-head trial, there is a suggestion that Micra is the better of the two (AHA – Medtronic leads in leadless pacemakers, November 10, 2015).

An FDA panel convened in February to discuss both Micra and Nanostim, but this was not an adcom to advise on their approvability but to provide recommendations for postapproval study design and training for cardiologists.

Experience

Approval is just the start. These tiny implants must carve out a niche and while they have advantages – being transcatheter the implantation procedure is quicker and safer than surgery, and recovery is faster – they are only suitable for a small fraction of arrhythmia patients.

St. Jude will have one advantage over Medtronic in the market: clinical experience outside the US. Nanostim was CE marked in 2013 and has been implanted in more than 1,000 patients worldwide, St. Jude says, and with Micra CE marked just a year ago Medtronic cannot claim a similar level of evidence.

St. Jude’s device could be competitive if it does get the nod from the FDA. But it needs this to happen as soon as possible – its rhythm management sales are slipping as Medtronic’s expand.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter