Boston Scientific Gets FDA, CE Mark Nod for EMBLEM S-ICD System

Boston Scientific said Tuesday that it received FDA and CE mark approval for its EMBLEM Subcutaneous Implantable Defibrillator System. The device is the first and only completely subcutaneous ICD, the Marlborough, Mass., devicemaker said.

Unlike traditional ICDs, which involve placing at least one lead in or on the heart, EMBLEM S-ICD is attached beneath the skin, allowing for a less-invasive approach. This is especially important because implanted leads can lead to serious complications, including lead displacement, systemic blood infections and the need for lead removal — a source of hospital readmission, higher mortality and increased costs, the company said.

The new system is also 19 percent thinner and 40 percent longer lasting than prior S-ICDs, reducing patient discomfort and the number of replacements, the company added.

Boston Scientific has released EMBLEM S-ICD in limited European markets, with a continent-wide launch set for May. The device will launch in the U.S. in the third quarter of this year. — Jason Scott