Medtronic, start-ups vie to debut leadless pacemakers

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Medtronic Inc. (NYSE:MDT) is quietly working on plans to develop a pacemaker that can deliver electricity to the heart without wires.

The Fridley, Minn.-based company confirmed to MedCity News that it’s building a leadless pacemaker but offered no further details on the device, which reportedly can be implanted directly into the right ventricle.

Several medical device firms have been pursuing leadless cardiac devices in recent years.

San Clemente, Calif.-based Nanostim Inc. is also working on a wireless pacemaker system that protects the heart in case the device pops loose.

Sunnyvale, Calif.-based EBR Systems Inc. is developing a system that uses ultrasound to activate a tiny device in the heart that converts the acoustic energy into electricity. Eden Prairie, Minn.-based Split Rock Partners, an early stage venture capital firm, is a major investor in EBR Systems. The start-up was co-founded by former Medtronic director of engineering Richard Riley.

In May, San Clemente-based Cameron Health Inc. announced promising results from a clinical study testing the first-of-its-kind implantable cardioverter defibrillator subcantaneous system that avoids the traditional method of snaking leads through veins. Boston Scientific Inc. (NYSE:BSX) is an investor in Cameron.

That Medtronic, the world’s largest medical device maker, should embrace leadless devices represents a remarkable shift not only for the company but for the industry as well. For years, medical device makers raced to develop smaller and thinner leads, which allowed surgeons to implant devices with greater ease and flexibility.

Medtronic has spent several years and millions of dollars to develop its next generation Sprint Fidelis leads. In 2007, however, the company stopped selling the lead after reports the wire broke apart inside the body. Countless lawsuits from investors and patients followed, culminating in a Supreme Court decision that ruled Medtronic could not be held liable for a device that met the FDA’s regulatory standards.

Earlier this year, Medtronic told doctors that lead failures may have factored into at least 13 deaths. Up to this point, surgeons have implanted about 260,000 Sprint Fidelis leads in patients in the U.S., with 143,000 still active. Leads can’t be easily removed, which is why Medtronic had advised patients to leave them in.

A report by UBS Investment Research said lead failures could accelerate over time, citing independent studies that predict failure rates could hit 30 percent by four years. Medtronic’s own data suggests a 3 percent failure rate at three years. The report said "fidelis may cast a long shadow"
over the $5 billion ICD market.

Wireless devices could go a long way in easing the worries of nervous patients. Plus implanting the devices without threading wires through the veins would lower the cost of the surgery, said Charles Huff, an analyst with Dougherty & Co., an Minneapolis-based investment bank.

It’s probably no accident that Medtronic is starting with the pacemaker — an ICD is a significantly more complicated device. But implanting the pacemaker directly into the heart presents its own safety problems if the device breaks loose.

“The potential of detachment of the leadless biostimulator from the implant site would represent an immediately serious event, as for example, a pacemaker lost from the right ventricle can exit the heart via the pulmonic valve and lodge in the lung,” according to documents Nanostim filed with the U.S. Patent and Trademark Office.

Nanostim is working on a system that would feature “secondary fixation,” a tether made from biomaterials that would further secure the device to the heart and “prevent escape of the pacemaker into the circulation downstream from the heart.”

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