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Next-generation subcutaneous ICD system receives FDA approval, CE Mark

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Boston Scientific announced that it has received FDA approval and a CE Mark for a second-generation subcutaneous implantable cardioverter defibrillator system.

The EMBLEM S-ICD system is intended to treat patients at risk for sudden cardiac arrest without affecting the heart and vasculature, through implantation under the skin, according to a press release. Subcutaneous placement reduces the risk for complications that can result from the placement and extraction of leads in or near the heart, according to the release.

“With the already established robust safety and efficacy clinical data, the EMBLEM S-ICD system is designed to enhance patient comfort while still providing a less-invasive treatment for patients at risk of cardiac arrest,” Kenneth Stein, MD, chief medical officer, rhythm management at the company, said in the release.

The company has initiated a controlled, limited release in small centers throughout Europe, with a larger European launch planned for May and a U.S. launch to follow during the third quarter of 2015.