Medical equipment manufacturer Boston Scientific has obtained FDA and CE mark approval for its Emblem Subcutaneous Implantable Defibrillator (S-ICD) system.
The S-ICD system has been developed to provide protection for patients at risk of sudden cardiac arrest (SCA) and minimize the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs).
Boston Scientific rhythm management chief medical officer Dr Kenneth Stein said: "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.
"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."
Implanted just under the skin, the S-ICD System provides protection to the patient from cardiac arrest without invading the heart and blood vessels, while traditional ICD require placement of at least one lead in or on the heart.
According to the company, the system is also enabled for remote patient management through the Latitude NXT Patient Management System for increased patient convenience.
Boston Scientific rhythm management president and executive vice-president Joe Fitzgerald said: "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."
The company has initiated a controlled and limited market release of the product in a small number of European centers, and is planning wider European launch in May this year, while the US launch in the third quarter.