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New Device Approval

Stelix lead	Stelid lead

Stelid II, Stelix, and Stelix II steroid eluting endocardial pacing leads - P020030

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: Stelid II endocardial pacing lead models BTF25D, BTF26D, BJF24D, BJF25D, UTF25D, and UTF26D. Stelix endocardial pacing lead models BR45D and BR46D. Stelix II endocardial pacing lead models BRF25D and BRF26D.
Manufacturer: ELA Medical, S.A.
Address: 98 Rue Maurice Arnoux, Montrouge 92120, FRANCE
Approval Date: June 17, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020030a.pdf

What is it? The Stelid II, Stelix and Stelix II endocardial pacing leads are surgically implanted wires that connect the heart to an implanted pacemaker. The lead allows a pacemaker to monitor the heart and it slowly releases a steroid (Dexamethasone Sodium Phosphate) into the body. The type of lead chosen depends on the pacing needs of the patient.

How does it work? A lead is inserted through a large vein connected to the heart. The leads have different methods of attachment depending on where the leads are being placed in the heart.

• The Stelid II leads have a sharp prong (tine) that is inserted into the wall of a lower chamber of the heart (ventricle).
• The Stelix and Stelix II leads are placed against the wall of a lower chamber of the heart (atrium).

Once a lead is placed in the heart and connected to an implanted pacemaker, electrical signals are received from the heart and transmitted to the pacemaker. The leads detect and transmit electrical signals from the heart to the attached pacemaker, and the pacing output from the pacemaker is sent through the lead to the heart. The steroid Dexamethasone Sodium Phosphate (< 1.0 mg) is released into the body from the tip of the lead.

When is it used? The Stelid II, Stelix, and Stelix II leads are designed to be used with an implantable pacemaker for pacing and sensing of the heart. The type of lead chosen depends on the pacing needs of the patient.

• The Stelid II BTF leads are used for patients requiring a bipolar ventricular pacing lead.
• The Stelid II UTF leads are used for patients requiring a unipolar ventricular pacing lead.
• The Stelid II BJF, Stelix, and Stelix II leads are used for patients requiring a bipolar atrial pacing lead.

What will it accomplish? The Stelid and Stelix leads, along with the pacemaker, will provide pacing threshold, pacing impedance, and sensing threshold values that are equivalent to controls with adverse event rates similar to control leads. The Stelix and Stelix II leads have equivalent or better electrical performance than controls and similar or fewer adverse events than controls.

When should it not be used? The leads should not be implanted in patients who:

• have mechanical tricuspid valves, or
• are contraindicated for a single dose of 1.0 mg of the steroid Dexamethasone Sodium Phosphate.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf2/p020030.html

Other:

• National Institutes of Health information on pacemakers:
  http://www.nlm.nih.gov/medlineplus/ency/article/007070.htm
• Illustrated placement of a pacemaker and leads:
  http://www.nlm.nih.gov/medlineplus/ency/imagepages/19566.htm

August 23, 2004

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