The FDA gave Greatbatch Medical the green light to market a sutureless myocardial pacing lead for ventricular pacing and sensing.
The Myopore Sutureless Myocardial Pacing Lead can be used when ventricular epicardial attachment is required, or when a transvenous lead fails to provide effective pacing. The lead is a sutureless wire with a screw-in tip that is surgically implanted as part of a pacemaker, defibrillator or cardiac resynchronization therapy device. Once implanted it can send signals and electrical impulses to the heart muscle.
The device may be useful in patients who have small veins, congenital heart disease, tricuspid valve abnormalities or when other leads are in place, preventing additional leads in the veins. “This type of lead is useful in situations where it is required that the potential for lead dislodgement be diminished or pacing and/or sensing will be established subsequent to open heart surgery,” the FDA proposed.
It is contraindicated in patients whose ventricular myocardium is thin walled, suffused with fat or fibrotic tissue, or is heavily infarcted. It should not be implanted in the atria.
The Myopore device has been commercially available since 1991. The premarket approval was required under federal regulations passed in 2012 for marketed pre-amendment Class III cardiovascular permanent pacemaker electrode products.