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Europe grants its first CE mark for leadless pacemaker to treat left ventricle

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An illustration of EBR Systems' leadless pacemaker (white) in relation to the heart--Courtesy of EBR Systems

EBR Systems' WiSE leadless pacemaker just earned a CE mark, becoming the first device in the class approved for improving left ventricular function. Medtronic and St. Jude Medical also offer leadless pacemakers, but they are implanted in the heart's right ventricle.

The Sunnyvale, CA, company said it would spend the next 12 months "working with leading European clinicians to assess different strategies for optimizing endocardial pacing location that maximize CRT (cardiac resynchronization therapy) benefits," suggesting that commercialization won't occur immediately, as is often the case following the receipt of a CE mark.

The device has an addressable market of 1.5 million heart failure patients, according to a company release.

EBR says in the release that its Wireless Stimulation Endocardially (WiSE) Technology improved the symptoms of 81% of heart failure patients at 6 months in a 35-subject study of those who had failed conventional cardiac resynchronization therapy. The device was implanted successfully in all but one of the patients.

"A growing body of evidence strongly suggests EBR's WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants," said EBR Systems CEO Allan Will in a statement. "We look forward to working with leaders in the European clinical community to further characterize the benefits of wireless endocardial pacing."

Conventional pacemakers provide cardiac resynchronization therapy by shocking the heart via electrical wires called leads. They have been the subject of numerous safety scares in the past.

In February, St. Jude ($STJ) agreed to pay as much as $14.25 million to settle about 950 claims related to instances of its failed Riata defibrillator leads, which unexpectedly degraded in as few as four years. Meanwhile, the failure of Medtronic's ($MDT) leads also led to multiple patients deaths about 8 years ago; the incident is often cited as an example of the need to improve postmarket surveillance of devices.

Moreover, EBR says 30% of patients who receive a conventional pacemaker do not respond to the therapy. The WiSE consists of a small electrode implanted in the left ventricle that paces the heart via electrical energy. The electrode generates electricity by converting an ultrasound signal received from a small transmitter placed between the ribs.  

Placing the implant inside the left ventricle generates so-called endocardial stimulation, which the company says is better than traditional epicardial stimulation. Epicardial stimulation occurs when the electrical implant is placed on top of the left ventricle. Another advantage of leadless pacemakers is their small size, which makes them easier to implant than the conventional (non-leadless) versions.

In April a strategic device company, a former Medtronic president, and VCs like Split Rock Partners and SV Life Sciences contributed $20 million toward EBR Systems' now-successful effort to develop the first leadless pacemaker for the left ventricle.

Meanwhile, St. Jude's Nanostim became the first CE marked leadless pacemaker in 2013. The device got off to a bumpy start after it was associated with a few deaths, but commercial implantations have since resumed. Meanwhile, Medtronic in April entered the market with its leadless Micra. The bigwigs' devices are distinct from the WiSE because they are implanted in the right ventricle, not the left one.

Both of their devices are in clinical trials for FDA approval. EBR made no mention of any FDA-approved clinical trials in its release.

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.

Boston Scientific's ($BSX) fast-selling S-ICD has shown the potential of cardiology technology that eliminates or lessens 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. Its leads do not contact the heart, making them safer than the others. 

- read the release

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