Boston Scientific announces FDA and CE mark approval of the Emblem S-ICD system


Boston Scientific has received FDA and CE mark approval of the Emblem subcutaneous implantable defibrillator (S-ICD) system. The system is a treatment option that provides protection for patients at risk of sudden cardiac arrest, yet leaves the heart and vasculature untouched, minimising the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators.

A controlled and limited market release has begun in a small number of European centres with a broader European launch scheduled for May 2015 and subsequent US launch planned for the third quarter of 2015.

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

Unlike traditional implantable defibrillator systems that require placement of at least one lead in or on the heart, the S-ICD system is implanted just under the skin and provides the patient the same protection from cardiac arrest without invading the heart and blood vessels. Leads in the heart may be associated with infrequent but serious complications, including lead displacement, fracture and systemic blood infections, or the need for lead extraction, which may lead to hospital readmission, increased mortality and associated costs.

Emblem is 19% thinner and is projected to last 40% longer than the previous system, improving patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. The S-ICD system is also enabled for remote patient management through the Latitude NXT patient management system for increased patient convenience.