In the largest study of its kind, Boston Scientific’s Subcutaneous Implantable Defibrillator System demonstrated a high success rate and low complication rate in treating sicker patients and those who would usually get a transvenous ICD.

The data was presented last Thursday at the Heart Rhythm Society’s 38th Annual Scientific Sessions in Chicago.

The system became the world’s first commercially available S-ICD for treating patients at risk of sudden cardiac arrest when it received FDA approval in September 2012.
The device doesn’t require leads to be placed inside the heart.

The non-randomized study, initiated after the system received FDA approval, included 1,637 patients who were implanted with the device at 83 medical centers in the U.S. Almost two-thirds of them were primary prevention patients with a low ejection fraction, which refers to how well their ventricle pumped blood with each heartbeat.

In addition, over half of the patients suffered comorbidities, including heart failure and hypertension, and more than 13 percent were on dialysis for end-stage renal disease.

The research revealed that the S-ICD system effectively terminated life-threatening arrhythmias in 98.7 percent of the patients. Thirty days after the procedure, the complication-free rate was 96.2 percent.

"Beyond the positive clinical outcomes, we are also seeing advancements in procedural techniques as physician experience and confidence continue to build," Dr. Kenneth Stein, senior vice president and chief medical officer of global health policy and rhythm management at Boston Scientific, said in a statement.

Physicians are now capable of implanting over half of the devices with two surgical incisions instead of the standard approach, which involves three incisions. They can also avoid the use of general anesthesia in more than one-third of patients.

Last month, Boston Scientific initiated a global study that will evaluate its latest generation device, the EMBLEM MRI S-ICD System. The Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator will evaluate the survival benefit of patients treated with the device who are 65 and older with a history of heart attack, diabetes, and moderately reduced left ventricular ejection fraction.

The EMBLEM MRI S-ICD System received FDA approval in August 2016 for patients at risk of sudden cardiac arrest. It doesn’t touch the heart and vasculature, which reduces the risk of complications associated with conventional TV-ICD leads.

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