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Smart pacing lead offers more accurate sensing

St Jude Medical : 09 May, 2007  (New Product)
St Jude Medical has announced US Food and Drug Administration (FDA) approval of its new OptiSense lead
The OptiSense lead is a first-of-its-kind 'smart' pacing lead designed to offer more accurate sensing in the upper chamber of the heart (right atrium).

The lead incorporates a new tip design that reduces extraneous signals from the heart's lower chambers (ventricles) that can interfere with a pacemaker's sensing mechanism and disrupt optimal therapy.

The OptiSense lead's improved sensing of desired electrical signals in the atria allows physicians more flexibility in programming atrial sensitivity settings while avoiding sensing signals from the ventricles.

This allows for more accurate detection of impulses from the patient's atrium.
In the past, physicians sometimes had to program a pacemaker to be less sensitive to avoid the detection of interfering signals.

However, while decreasing the sensitivity settings helps to reduce the interfering signals, it can also reduce the sensing of important signals, like the small signals that can occur during atrial arrhythmias.

More sensitive atrial sensitivity settings are, therefore, especially important in patients with atrial tachyarrythmias (an abnormally fast heart rate), such as atrial fibrillation.

By reducing the detection of unwanted signals, the OptiSense lead may also provide physicians greater freedom in lead placement options.

Now, leads may be able to be placed in areas, such as the lower inner atrium, that may be optimal for pacing, but that may have previously been ruled out because of interfering signals from the heart's lower chambers.

A lead is an insulated wire that is placed through the vein as part of a pacemaker implantation procedure.

Its tip is attached to the heart tissue, while its other end connects to the pacemaker.

A lead carries electrical impulses from the implanted device to the heart and transmits information from the heart back to the implanted device.

The improved sensing performance of the OptiSense lead is a result of an innovative 1.1 mm tip-to-ring spacing, which reduces oversensing of far-field R-wave signals (an electrical signal originating in the lower chamber of the heart and sensed by the lead in the upper chamber of the heart).

The conclusions reached by the OptiSense Lead Clinical study include the following:

- The OptiSense lead had no evidence of paced far-field signals in 90.9 percent of patients compared to 40.9 percent of the control patients (p less than 0.0001).

- The OptiSense lead group exhibited a highly statistically significant reduction (p = 0.03) in the percentage of patients with inappropriate mode switching (6.9 percent of OptiSense patients versus 25.7 percent of control group patients) as well as a highly statistically significant reduction (p = 0.009) in the percentage of episodes of inappropriate mode switching (three percent versus 49 percent).

Inappropriate mode switching is not desirable because, if it occurs, it can cause a loss of synchrony between the upper and lower chambers of the heart.

'The innovative design of the OptiSense lead offers significant advantages for both physicians and patients', said Michael J Coyle, president of St Jude Medical's Cardiac Rhythm Management Division.

'These new features enhance pacemaker function, support physician preferences to pace more physiologically and provide better therapies for patients'.

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