Boston Scientific (NYSE:BSX) today said it won both CE Mark approval in Europe and a nod at home from the FDA for the latest iteration of its "leadless" implantable cardiac defibrillator, the Emblem S-ICD.
Unlike other ICDs, the S-ICD delivers its regulating shock via subcutaneous leads, rather than with leads threaded through blood vessels to the heart. The Emblem model is 19% slimmer and projected to last 40% longer than the original S-ICD, Marlborough, Mass.-based Boston Scientific said.
A "controlled and limited market release" is under way in "a small number" of sites in Europe, with a full-scale launch there on tap for May, according to the company. A U.S. launch is planned for the 3rd quarter, Boston Scientific said.
"We are excited to offer the 2nd-generation S-ICD System to physicians as a compelling treatment option for the majority of ICD-indicated patients," chief medical officer for rhythm management Dr. Kenneth Stein said in prepared remarks. "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," added rhythm management president Joe Fitzgerald. "Boston Scientific is the 1st 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."