The European Society of Cardiology updated its treatment guidelines for ventricular arrhythmia patients to include subcutaneous implantable cardioverter defibrillators. The announcement was made at the society’s annual meeting in London on Saturday.
The new guidelines recommend the use of the S-ICD units as a possible alternative to transvenous defibrillators in patients with an ICD indication who don’t require cardiac resynchronization or pacing therapy for bradycardia and antitachycardia.
“As the manufacturer of the world’s 1st and only subcutaneous defibrillator, we are extremely pleased that the updated ESC guidelines have now been published. The guidelines recognise the strong clinical science supporting the compelling benefits of a device that can protect a broad range of patients from sudden cardiac death while leaving the heart and vascular system untouched. This represents another important milestone after the launch of Emblem S-ICD System, the second generation S-ICD, earlier this year,” Boston Scientific (NYSE:BSX) chief medical officer Dr Kenneth Stein said in a press release.
The ESC gave the device an official class IIa recommendation with the change to its guidelines.
In June, Boston Scientific launched a global clinical trial for its Emblem S-ICD in primary prevention patients with severely reduced cardiac function. The study is slated to enroll a minimum of 2,015 patients with no documented, life-threatening arrhythmic event who are at risk of sudden cardiac death.
Earlier in April, Boston Scientific touted a study published in the Journal of the American College of Cardiology showing the long-term safety and effectiveness of its S-ICD “leadless” defibrillator.
The study pooled 6-month to 1-year data from a pair of Boston Scientific-funded clinical trials, the S-ICD investigational device exemption trial and the Effortless post-market trial.