Atrial-sensing single-lead ICD gets FDA clearance

February 25, 2013

Lake Oswego, OR - A single-chamber implantable cardioverter-defibrillator (ICD) with the novel addition of atrial-sensing capability to its one lead has been granted market approval by the FDA, Biotronik announced today [1].

Its Lumax 740 DX system can potentially provide the benefits of atrial sensing to selected patients who might benefit, without the added implantation time and complication risk that come with a dedicated atrial-sensing lead.

The system comes with software that can discriminate between supraventricular tachycardia, atrial fibrillation, and atrial flutter in the atrial signals from the one lead, according to the company.

The Lumax 740 DX system is already available in Europe and Japan, Biotronik says.


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