Boston Scientific has received regulatory approval from the US Food and Drug Administration (FDA) for its cardiac rhythm management device, which is designed to treat patients at risk for sudden cardiac arrest (SCA).
The CE-marked subcutaneous implantable cardioverter defibrillator (S-ICD), which the company claims is the world’s first S-ICD system, features a pulse generator which is implanted at the side of the chest to monitor heart activity and deliver a shock if needed.
An electrode is also implanted beside the breastbone, which enables the device to sense the cardiac rhythm and deliver shocks.
Implantation of the S-ICD system is done using anatomical landmarks, without the need for fluoroscopy as transvenous ICDs require, according to the company.
The approval was granted following positive test results from a 330-patient, multicentre, non-randomised prospective clinical study, designed to assess the safety and effectiveness of the S-ICD system.
The study met the primary endpoints and the results were presented at the Heart Rhythm Society 33rd Annual Scientific Sessions earlier in 2012.
The Ohio State University cardiovascular clinical associate professor, Raul Weiss, said with the launch of S-ICD system, doctors now have a new treatment option that provides protection from SCA without touching the heart.
Boston Scientific chief executive officer Hank Kucheman said, "The S-ICD System, coupled with our numerous recent regulatory approvals and our other innovative products, such as the WATCHMAN Left Atrial Appendage Closure Device and Alair Bronchial Thermoplasty System for the treatment of severe asthma, demonstrates our continued commitment to developing and bringing to market innovative products for physicians and their patients."