FDA approves 2nd generation subcutaneous ICD

The FDA approved Boston Scientific’s Emblem subcutaneous implantable defibrillator (S-ICD) system, which is expected to be available in the U.S. by the third quarter of this year.

This is the second generation of the device, which became the first FDA-approved S-ICD in 2012. The technology uses a pulse generator and an electrode to provide a less invasive treatment for patients at risk of sudden cardiac arrest. Physicians implant the device under the patient’s skin, and it does not require lead implantation in the heart.

The newer generation is 19 percent thinner with a 40 percent longer projected life than its predecessor, according to Boston Scientific. It can be paired with the Latitude NXT patient management system for patient monitoring.

The Emblem S-ICD also received CE mark, with an expected European launch in May.