Medtronic wins FDA approval of new ICDs
Minneapolis-based Medtronic Inc. has received FDA approval for the first model in a new line of implantable cardioverter-defibrillators (ICDs).
The GEM III DR ICD (Dual Chamber Model 7275), used with Medtronic Sprint defibrillation leads and the Medtronic 9790 programmer, is the first in a new family of implantable systems designed to treat potentially lethal heart rhythms such as sudden cardiac arrest.
The dual-chamber GEM III DR device is for patients with conditions requiring that sensing take place in both the upper and lower chambers of the heart to assure that the device circuitry correctly evaluate arrhythmias to prevent inappropriate therapeutic impulses. It includes enhanced PR (Pattern Recognition) Logic detection capabilities, which are intended to improve upon the devices' ability to discriminate between lethal and non-lethal heart arrhythmias.
GEM III defibrillators are expected to last about six years in typical use, an increase of more than a full year over their most recent Medtronic predecessors. They incorporate the company's proprietary energy and integrated circuitry capable of producing short charge times while delivering 30 joules of defibrillation therapy needed to correct a potentially lethal heart rhythm. The Patient Alert function continuously monitors the system's performance and alerts the patient automatically with an audible tone when it has collected data requiring a physician's attention.
The company is also awaiting FDA approval of the single-chamber GEM III VR (Model 7231) for use with patients who do not require upper-chamber sensing and pacing. The FDA is also reviewing the GEM III AT ICD for managing tachyarrhythmias in both upper and lower chambers of the heart.
With contribution from Ursula Jones
Managing Editor, Medical Design Online