FDA Approves New St. Jude Medical Defibrillator

St. Jude Medical Inc. has been granted FDA approval for commercial distribution of the Ventritex Profile MD implantable cardioverter defibrillator (ICD). The device was released outside the United States last month.

Thirty percent thinner and smaller than comparable competitive devices, this single-lead system for treating dangerously fast heart rates combines implant simplicity with full functionality, including advanced tachyarrhythmia discrimination capabilities.

Resembling a pacemaker in its size and physiologic shape, the 11-mm-thin ICD is designed for patient comfort and ease of implantation. With a volume of 34 cc and maximum stored energy of 32 joules, the device continues the Ventritex tradition of providing full therapeutic power in a small package, enabled by proprietary Flatcap capacitor technology.

The Profile MD device offers the proprietary Morphology Discrimination algorithm for differentiating between life-threatening ventricular (lower-chamber) tachyarrhythmias and somewhat less serious atrial (upper-chamber) tachyarrhythmias. Basing discrimination on several different characteristics of an electrogram complex, this algorithm gives the physician an option for tailoring tachyarrhythmia discrimination to the individual patient, particularly when the nature of a patient's tachyarrhythmia makes it unresponsive to other discriminators. Accurate discrimination is intended to provide protection against the discomfort caused by inappropriate shocks, which can occur when an atrial tachyarrhythmia is mistaken for a ventricular tachyarrhythmia.