3. Lukewarm: Miniature Leadless Pacemakers

3. Lukewarm: Miniature Leadless Pacemakers

A mind-blowing feat of engineering, leadless pacemakers could prove to be a cash cow for Medtronic and St. Jude (its Nanostim is shown above), which both have such products on the market in Europe. (Boston Scientific and Biotronik are each developing their own versions of the devices, which fit within the heart's right ventricle.) But an FDA panel recently ruled that the devices warrant long-term scrutiny. One of the concerns surrounding the device is the risk of cardiac perforation, a potentially lethal injury that may be a higher risk than with traditional pacemakers, according to New York cardiologist Jeffrey Borer, MD, who points to data suggesting that the risk of perforation is 50% higher with the leadless pacemakers. Still, the field of cardiac rhythm management devices had seen little innovation since the debut of cardiac resynchronization therapy in the early 2000s and leadless pacemakers could potentially be a disruptive technology if the makers of the devices can sway regulators that the technology is indeed clinically superior. The market for cardiac rhythm management devices is worth some $9 billion annually, but growth in the sector has been almost nonexistent according to Larry Biegelsen, a senior analyst with Wells Fargo Securities.

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