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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Medtronic® Attain StarFix™ Model 4195 Lead
PMA Applicant: Medtronic, Inc.
Address: 1015 Gramsie Road, Shoreview, MN 55126-3082
Approval Date: June 13, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060039a.pdf
What is it? The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over the surface of the heart’s left ventricle. The tip of the lead has lobes that open to help keep it in place. A small amount of steroid (beclomethasone dipropionate ) at the tip is intended to reduce inflammation of the surrounding tissue. The other end of the lead connects to an implanted biventricular pacemaker or implantable cardioverter defibrillator (ICD), so signals and electrical impulses can be sent between that device and the left ventricle.
How does it work? In some heart-failure patients, the right and left sides of the heart may not contract together, at the same time. The 4195 lead as part of a biventricular system sends electrical impulses to the heart to promote simultaneous contraction of both ventricles.
When is it used? The Model 4195 lead is used with a compatible implantable pacemaker or implantable cardiac defibrillator to provide chronic pacing and sensing of the left ventricle. Additional leads in other heart chambers are used with the pacemaker to coordinate the entire heart’s action at a regular, appropriate rate.
What will it accomplish? The Attain StarFix™ Model 4195 Lead, in conjunction with an implanted pacing device and other leads, helps the heart chambers pump more efficiently by coordinating the timing of contractions. This improved coordination may reduce the symptoms of heart failure and is called cardiac resynchronization therapy, or CRT.
When should it not be used? The Attain StarFix™ Lead Model 4195 should not be used in patients with blocked or inadequate blood vessels for placing leads, or in patients who cannot tolerate a small dose of beclomethasone dipropionate (30 μg).
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060039