Martin C Burke, University of Chicago, USA, presented the results of the S-ICD System investigational device exemption clinical trial at a late-breaking session at the Heart Rhythm Society’s 33rd Annual Scientific Sessions (9–12 May, Boston, USA). Data show that the S-ICD System met the primary safety and efficacy endpoints.
The S-ICD System is the world’s first completely subcutaneous implantable defibrillator (ICD) for the treatment of patients at risk for sudden cardiac arrest. The S-ICD System offers the same defibrillation therapy option as most conventional ICDs, but without transvenous leads-thereby eliminating many of the serious complications commonly associated with transvenous leads.
“Conventional ICDs are a proven therapy with a long clinical track record; however, complications related to transvenous leads, or wires placed in the heart, can be quite serious for patients,” said Burke, professor of Medicine and director of the Heart Rhythm Center, University of Chicago, USA. “We did not observe the typical lead-related complications with the S-ICD System, so having an alternative treatment for patients that can virtually eliminate transvenous lead complications is an important step forward for ICD therapy.”
The S-ICD System IDE trial is a prospective, non-randomised, multicentre clinical study that enrolled 330 patients meeting current AHA/ACC/HRS Class I and II ICD indications and who did not require long-term bradycardia pacing. The primary endpoints for the study were designed to demonstrate safety and efficacy of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
“The compelling results of this landmark clinical study add to the growing body of evidence that demonstrate the benefits of this important alternative for patients at risk from sudden cardiac arrest. Furthermore, we are equally committed to evaluating the real-world performance of the S-ICD System via our long-term EFFORTLESS S-ICD registry,” said Kevin Hykes, president and CEO, Cameron Health. The preliminary results from the registry were also reported at the HRS.
On 8 March 2012, Boston Scientific announced that it would exercise its option to acquire Cameron Health. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.