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FDA Approves a Long-Distance Jump-Starter for the Heart

The FDA has approved a defibrillator that can be sewn just under the skin.

  • October 2, 2012

Heart patients in the U.S. are in for a treat. The FDA has approved a new kind of daily-wear defibrillator that can be sewn in just under the skin.

Boston Scientific

People with heart conditions walk around with pocket-sized defibrillators sewn into their chests with insulated wires snaking into their heart. If their heart encounters an electrical hiccup, causing an irregular beat, the implanted defibrillator shocks it back on track. If their heart stops altogether, the implanted defibrillator is in position to shock it awake.

For a few years now, Cameron Health has been testing a different kind of subcutaneous implantable defibrillator, or S-ICD. The device does its business from whole inches away without touching the heart. This makes it easier to implant into the body, and if worn out, safer to remove.

When Technology Review first encountered the device, Cameron Health was running a trial with six Kiwi heart patients. (Boston Scientific bought Cameron Health in March this year, and it is Boston Scientific who will sell the device in the U.S.)

Experts said then that a S-ICD located in the chest was better suited to monitoring the heart’s electric activity from afar. A traditional ICD is sometimes confused by electrical noise within the heart, and sometimes shocks a patient’s heart when it is working perfectly. Also, leads of the regular ICD embedded themselves in the heart tissue—and if those wore out, could only be replaced by open-heart surgery.

The S-ICD does away with leads altogether, and delivers a more powerful jolt to the heart from a longer distance away. The main device is implanted under the arm, and a connected electrode is positioned under the rib cage.

Boston Scientific conducted a study with 330 patients in the U.S. and presented the results of those trials at the Heart Rhythm Society’s annual meeting in May. The FDA issued its approval on Friday, September 28. The long-distance jump-starter is already on sale in some parts of Europe and New Zealand.

Moviemakers know and love the scene: In the middle of a tense conversation on a hospital bed, our hero’s heart suddenly stops. An alarm wails, an efficient army of nurses swoops in. And it is the defibrillator on a tray, with paddles, wielded deftly between yells of “Charging to 220!” and “CLEAR!” that brings our hero back into this world. 

It turns out real-life defibrillations are not necessarily all that dramatic, but frequently much cooler.

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