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Home Industry News Boston Scientific receives EU and US approval for Emblem S-ICD

Boston Scientific receives EU and US approval for Emblem S-ICD

23rd March 2015

Boston Scientific has announced that its Emblem subcutaneous implantable defibrillator (S-ICD) system has received US Food and Drug Administration and European CE Mark approval.

The device is designed to provide protection for patients at risk of sudden cardiac arrest, while leaving the heart and vasculature untouched. This helps to minimise the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators.

Implanted just under the skin, the device avoids the potential dangers associated with placing leads in the heart. Moreover, the Emblem S-ICD System is 19 percent thinner and is projected to last 40 percent longer than previous S-ICD offerings.

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

Dr Kenneth Stein, chief medical officer for rhythm management at Boston Scientific, said: "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."

This comes after the firm recently launched its line of Extended Longevity implantable cardioverter defibrillators, which are the longest-lasting products of their kind.ADNFCR-8000103-ID-801780781-ADNFCR

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