VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) - P130010
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: VEGA Steroid-Eluting Endocardial Pacing Lead
PMA Applicant: MicroPort CRM
Address: 5640 Airline Road, Arlington, TN 38002
Approval Date: May 17, 2023
Approval Letter: Approval Order
What is it?
The VEGA Steroid-Eluting Endocardial Pacing Lead is an insulated wire with a screw-in tip that is connected to a permanently implanted pulse generator, or pacemaker device, to carry signals from the heart muscle to the pulse generator and electrical impulses back to the heart to keep the heart beating in a normal rhythm (pace). The lead includes a steroid drug, dexamethasone sodium phosphate, that helps reduce inflammation in the heart muscle after the lead is placed.
How does it work?
The lead is implanted into the heart’s upper (atrium) or lower chamber (ventricle) through a vein in the upper chest (intravenously). The lead is placed on the inner surface of the heart muscle. It is connected to the implanted pulse generator to carry signals from the heart and electrical impulses back to the heart through the screw-in tip. The electrical impulses from the pulse generator keep the heart on pace.
When is it used?
The VEGA Steroid-Eluting Endocardial Pacing Lead is used along with an implanted pulse generator to serve as a pacemaker when patients have slow heart rates (bradycardia) and need pacing to maintain a normal heart rhythm.
What will it accomplish?
The VEGA Steroid-Eluting Endocardial Pacing Lead carries electrical impulses to the heart to make sure it beats at an appropriate rate to support the organs and the rest of the body.
When should it not be used?
The VEGA Steroid-Eluting Endocardial Pacing Lead should not be used in people with mechanical tricuspid valves. Additionally, it should not be used in anyone who cannot receive a single dose of dexamethasone sodium phosphate.
Additional information (including warnings, precautions, and adverse events):