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| An illustration of the S-ICD System--Courtesy of Boston Scientific |
Boston Scientific ($BSX) announced that it has received FDA and CE-mark approval to launch the next generation of its subcutaneous implantable defibrillator (S-ICD) system, which is implanted under the skin and does not have wires that come into contact with the heart.
The Emblem S-ICD is 19% thinner and lasts 40% longer that its predecessor, the company says. In addition, it is enabled for remote patient management using the company's Latitude NXT Patient Management System, which provides readings of weight, blood pressure, heart rate, respiratory rate and other biometrics.
The Emblem is already available in Europe on a limited basis, with a broad release expected in May; a U.S. launch is scheduled for Q3. That gap of only a few months is significant because upgraded devices often launch in the U.S. a year or more later than they do in the Europe, as is the case with TAVRs for patients too frail for open heart surgery.
"Boston Scientific is the first and only company to offer a fully subcutaneous ICD, and we expect to maintain leadership in this category through continued investment in technology and clinical science. We are very pleased with this earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the Emblem device in the US," said the executive vice president of the company's Rhythm Management unit, Joe Fitzgerald, in a statement.
The enhancements are relatively minor compared to the product's main differentiating feature. The S-ICD's leads (or wires) do not come into contact with the heart, which should improve patient safety. It is the only implantable defibrillator that does not contact the heart directly.
Faulty defibrillator leads are cited as an instance of industry failure and a reason for better postmarket surveillance. St. Jude Medical ($STJ) recently agreed to pay as much as $14.25 million to settle about 950 claims related to its Riata defibrillator leads.
At investor events, Boston Scientific officials have consistently said the S-ICD is meeting or exceeding expectations. In addition, the company recently announced upgrades to its other ICDs. The new, "extended longevity" Dynagen EL and Inogen EL have a battery life of up to 12 years.
Another arena to keep an eye on in the march away from leads is pacemakers. St. Jude Medical's Nanostim was the first leadless pacemaker to hit the market with the receipt of a CE mark in 2013. Medtronic's ($MDT) leadless Micra is nearing approval in Europe.
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