FDA and CE Mark Approval for Boston Scientific’s Thinner S-ICD System

Boston Scientific Corporation has received FDA and CE Mark approval of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System which is 19% thinner and projected to last 40% longer than its previous S-ICD System.

Background

Traditional ICDs require placement of at least one lead in or on the heart. In contrast an 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. This also avoids infrequent but nonetheless serious complications that can result from leads placed in the heart, so-called transvenous implantable cardioverter-defibrillators (TV-ICDs). Problems can include lead displacement, fracture and systemic blood infections, or the need for lead extraction, all of which may lead to hospital readmission, increased mortality and associated costs. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest (SCA), yet leaves the heart and vasculature untouched.

By making the new generation EMBLEM S-ICD System significantly thinner and longer lasting than its predecessor, it is hoped to improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement.

The EMBLEM S-ICD System is also enabled for remote patient management through the LATITUDE™ NXT Patient Management System for increased patient convenience.

A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015.

Company comments

“We are excited to offer the second generation S-ICD System to physicians as a compelling treatment option for the majority of ICD-indicated patients,” said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management, Boston Scientific. “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.”

“We are further strengthening our range of therapeutic solutions to protect patients from sudden cardiac arrest,” said Joe Fitzgerald, executive vice president and president of Rhythm Management at Boston Scientific. “Boston Scientific is the first and only company to offer a fully subcutaneous ICD, and we expect to maintain leadership in this category through continued investment in technology and clinical science. We are very pleased with this earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the EMBLEM device in the US.”

Source: PR Newswire

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