Introducing the S-ICD® System, the world's first and only Subcutaneous Implantable Defibrillator

The approval of the S-ICD System introduces a new class of implantable defibrillators that enable you to offer new solutions to your patients and better balance risk with therapeutic benefit. Like transvenous ICDs, the S-ICD System utilizes a pulse generator capable of delivering life-saving high-energy shocks to convert VT/VF. Unlike transvenous ICDs, the S-ICD System is implanted in the lateral thoracic region of the body and utilizes a subcutaneous electrode instead of transvenous leads to both sense and deliver therapy.

The benefits of the S-ICD System include:

 

• Effective defibrillation therapy without transvenous leads
• Eliminates potential for vascular injury
• Reduces potential for systemic infection
• Preserves venous access
• May be implanted using only anatomical landmarks, reducing radiation exposure for both patient and physician

The S-ICD System has been commercially available in Europe and New Zealand since 2009 and has clinical evidence from a large patient registry in Europe and a large US premarket (IDE) clinical study demonstrating:

• Effective detection and conversion of induced and spontaneous VT/VF episodes1
• Low rates of significant clinical complications1
• Effective discrimination of AF and SVT from VT/VF1
• Rate of inappropriate therapy consistent with TV-ICDs1
• The S-ICD System uses highly sophisticated technology to identify and classify the heart rhythm—rather than individual beats—to effectively sense, discriminate, and convert VT/VF