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: ACUITY™ Steerable Lead Models 4554, 4555, and 4556
PMA Applicant: Guidant Corporation
Address: 4100 Hamline Avenue North, St. Paul, MN 55112-5798
Approval Date: April 13, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050046a.pdf
What is it and when is it used? The ACUITY™ Steerable Lead Models 4554, 4555, and 4556 are surgically implanted wires that connect the heart to an implanted cardiac resynchronization pacemaker. Pacemakers are small battery-operated electronic devices which are inserted under the skin to help chambers of the heart beat regularly and at an appropriate rate. The ACUITY™ Steerable Lead Models 4554, 4555, and 4556 allows a pacemaker to monitor and regulate the heart rate. A small amount of steroid (dexamethasone acetate) near the tip of the lead may help the lead perform well.
ACUITY transvenous leads are intended for chronic left-ventricular pacing and sensing via the coronary veins when used with a compatible pacemaker.
How does it work? The lead is implanted in the coronary vein, a large vein connected to the heart’s left ventricle. The lead has a J-shaped tip which keeps it from moving out of place. A small amount of steroid (dexamethasone acetate) is briefly released from the tip of the lead to help the tissue around it conduct electricity more easily. Once the lead is placed in the heart and connected to an implanted pacemaker, it detects and transmits electrical signals. The pacemaker sends electrical signals through the lead to pace the heart chambers at a specific rate. The heart responds to the electrical signals by beating at the same rate.
What will it accomplish? ACUITY™ Steerable Leads, in conjunction with an implanted cardiac resynchronization pacemaker, help the heart chambers pump blood by coordinating the timing of their contraction.
When should it not be used?
The ACUITY™ Steerable Leads should not be used:
- in patients who cannot tolerate a small dose of dexamethasone acetate steroid drug
- in patients with mechanical tricuspid heart valves
- in patients with blocked or inadequate blood vessels for placing leads.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050046