Boston Scientific announced results from the largest post-market registry for the Subcutaneous Implantable Defibrillator (S-ICD) System. Data collected from the EFFORTLESS study were presented as a late-breaking clinical trial at the 37th Annual Scientific Sessions of the Heart Rhythm Society (HRS) in San Francisco, and confirmed long-term safety and efficacy for the only device available to treat sudden cardiac arrest without leads touching the heart and vasculature.
The multi-national registry included 985 patients who were observed for up to five years post-implant – more than any S-ICD data the company has previously published. Primary results demonstrate low complication rates associated with the S-ICD device, with a complication-free rate of 99.7% at 30 days, and 98.0% at 360 days post-procedure.
"We have long believed in the value of eliminating unnecessary patient complications by choosing a defibrillator which does not require intracardiac leads," said Lucas V. A. Boersma, M.D., Ph.D., electrophysiologist at St. Antonius Hospital, The Netherlands. "This post-approval registry further confirms that not only is the Subcutaneous Implantable Defibrillator an effective therapy, but its benefits are consistent amongst the full range of indicated patient subsets."
The efficacy of the S-ICD System was further validated in this analysis, with a 97.4% conversion rate of discrete arrhythmias that can lead to sudden death.
Follow-up at an average 3.1 years revealed that few S-ICDs were removed due to a change of patient indication. Only five (0.5%) S-ICDs were removed in order to implant a patient with a defibrillator with anti-tachycardia pacing (ATP) capabilities, and only one (0.1%) was removed to allow for a device with bradycardia pacing capabilities.
"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," said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. "We are developing the EMPOWER™ Modular Pacing System, which includes our leadless pacemaker and the EMBLEM™ S-ICD System. Whether patients with life-threatening arrhythmias subsequently develop a need for pacing or vice versa, we are designing this modular solution to enable electrophysiologists to treat patients with the therapies they need, when they need them."
Since receiving CE Mark and U.S. Food and Drug Administration approval for the S-ICD System in 2009 and 2012, respectively, Boston Scientific launched a next generation EMBLEM S-ICD System which is 20% thinner and is projected to last 40% longer than the original S-ICD System. Last month, the company was granted CE Mark for the new EMBLEM MRI S-ICD System as well as magnetic resonance conditional labeling for all previously implanted EMBLEM S-ICD Systems, meaning the devices are considered safe for use in a magnetic resonance image setting when conditions of use are met.
For more information on the S-ICD Systems, visit www.sicdsystem.com .
In the U.S., the EMBLEM MRI S-ICD System and EMPOWER Modular Pacing System are not available for use or sale.
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