This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Myopore Sutureless Myocardial Pacing Lead
PMA Applicant: Greatbatch Medical
Address: 2300 Berkshire Lane North, Minneapolis, MN, 55441
Approval Date: April 30, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130012a.pdf
What is it? The Greatbatch Myopore Sutureless Myocardial Pacing Lead is a surgically implanted, insulated, and sutureless wire with a screw-in tip that is part of a permanently implanted pacemaker, defibrillator, or cardiac resynchronization therapy (CRT) device.
How does it work? The Myopore Lead is implanted by opening the chest or a making a small incision under the breastbone. The Lead is placed on the surface of the heart muscle so the screw-in tip end can electrically stimulate (pace) the heart’s lower chambers (ventricles).
When is it used? The Myopore Lead is connected to an implanted pacemaker, defibrillator or a CRT device to carry signals and electrical impulses to the heart muscle.
What will it accomplish? When placed on the surface of the heart as part of a pacemaker, the Myopore Lead paces the heart to assure that it beats at an appropriate rate. A CRT device uses two leads, one to pace each ventricle, either of which may be a Myopore Lead. A CRT device with two Leads is intended to coordinate and improve the ventricles’ timing to reduce symptoms of heart failure.
Using the Myopore Lead allows the implant of a pacemaker, defibrillator, or CRT device when other types of leads cannot be implanted. Examples include patients who have small veins, congenital heart disease, abnormalities of the tricuspid valve or when other the leads are already in place preventing additional leads in the veins.
When should it not be used? The Myopore Lead should not be used when a patient’s heart is too thin or damaged and should not be implanted on the surface of the heart’s upper chambers (atria).
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.