Medtronic, start-ups vie to debut leadless pacemakers

August 19, 2010 by MedCity News

Medtronic Inc. is quietly developing a wirelesss pacemaker, but several small companies are as well.

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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.