Boston Sci gains FDA nod for much-hyped S-ICD

Boston Scientific got FDA approval for the S-ICD implant.--Courtesy of Boston Scientific

What does $150 million get you these days? For Boston Scientific ($BSX), its acquisition of Cameron Health brought it the S-ICD. And now that the device has FDA approval, the buy brings hope to the company's flagging cardio unit.

The S-ICD cleared an FDA panel in April, but last week's full approval came ahead of schedule--Boston Sci had earlier hoped to get the device on the market in the first half of 2013. Instead, the company is starting a phased launch of the device, training surgeons around the country on how to implant the S-ICD.

Unlike other ICDs, which run wires through the venous system to regulate heart rhythm, the S-ICD is implanted just under the skin, acting like an external defibrillator when it detects cardiac arrest. As a result, the device doesn't require leads to be implanted into the heart, and Boston Sci hopes the less-invasive approach will be attractive to patients indicated for ICD therapy but wary of intense surgeries.

The S-ICD is the first device of its kind approved in the U.S., and interim CEO Hank Kucheman said the tech is just what Boston Sci needs to gets its cardiac business back on track. "With the addition of the S-ICD System, we believe Boston Scientific has a compelling and highly differentiated portfolio that will help fuel our growth strategy," Kucheman said in a statement. "We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years."

Boston Sci is following through on its promise to reverse the fortunes of its slumping cardio unit by rolling out more devices focused on in-demand spaces. Last week, the company launched its Emerge coronary catheter in the U.S., and Boston Sci announced its acquisition of BridgePoint Medical earlier in September, giving it the rights to sell that company's FDA-cleared devices.

The FDA's decision is good news for Cameron Health, too. Under the terms of the acquisition, Boston Sci owes the company another $150 million now that the device is approved and up to $1 billion more over 6 years if the device meets certain revenue goals.

- read Boston Sci's announcement
- here's the FDA's release

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