Boston Scientific reports positive data from long-term Emblem S-ICD study

Boston Scientific has announced new clinical data showing the effectiveness of its Emblem subcutaneous implantable defibrillator (S-ICD) system over a long-term period.

Results from EFFORTLESS, the largest post-market registry assessing the confirmed long-term safety and efficacy of the device, showed the strong performance of the system in treating sudden cardiac arrest without leads touching the heart and vasculature.

A total of 985 patients were observed for up to five years post-implant, with primary results demonstrating low complication rates associated with the S-ICD device. Complication-free rates of 99.7 percent at 30 days and 98 at 360 days post-procedure were seen.

Moreover, it was shown that only 0.5 percent of S-ICDs needed to be removed to implant a patient with a defibrillator with anti-tachycardia pacing capabilities, while only one was removed to allow for a device with bradycardia pacing capabilities.

Dr Kenneth Stein, chief medical officer for rhythm management at Boston Scientific, said: "We are building on the success we've seen with the S-ICD system by exploring a modular therapy approach that keeps the vasculature untouched."

The company has marketed its S-ICD devices in Europe since receiving CE Mark approval for the technology in 2009.