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Excimer Laser Sheaths

A ring of laser energy ablates binding tissue around the circumference of the lead, allowing for safe, accurate and efficient cardiac lead removal. The excimer laser operates in the ultraviolet spectrum at 308nm to safely ablate target tissue at a depth of 50 microns.

The SLS® offers:

Flexible distal segment and 15° bevel tip for advancement over acute lead angles
Internal lubricious coating for easy passage
50cm working length to treat taller patients
Comes with outer sheath, which acts as a low-friction conduit

In clinical study, the laser sheath showed a higher success rate for lead removal over mechanical methods:*

94% for SLS versus 64% for mechanical methods**
In 46 leads, fast extraction times were observed (time from sheath application until lead removed)
Median: 4 min—Mean: 5.3 min.***

*Byrd, C., et al. (2002). Clinical study of the laser sheath for lead extraction: The total experience in the United States. Journal of Pacing and Elelctrophysiology, 25(5).

** Wilkoff, B., et al. (2009). Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, 33(6).

*** Kennergren, C., et al. (2002). Lead extraction: Initial experience using a new laser sheath. Abstract 101892. NASPE.

Indications

The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

Contraindications

Use of the laser sheath is contraindicated:

When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life-threatening complication.
When fluoroscopy is not available.
In patients in whom superior venous approach cannot be used.
When the proximal end of the pacing lead is not accessible to the operator.
When the lead will not fit into the inner lumen of the laser sheath.

Warnings

The Laser Sheath should be used only by physicians who are experienced in pacing lead removal techniques using telescoping dilator sheaths. Protective glasses are required when the laser is in use. Avoid eye or skin exposure to direct or scattered radiation. Refer to exposure label on the CVX-300 Excimer Laser System. Do not insert more than one Laser Sheath or Outer Sheath into a vein at a time. Severe vessel damage, including venous wall laceration requiring surgical repair, may occur. Do not place the outer sheath tip at the SVC-atrial junction as it may damage this delicate area during subsequent procedures (e.g., moving the outer sheath, implanting a new lead).

Precautions

For single use only. Do not resterilize and/or reuse. Do not use the Laser Sheath: If the tamper-evident seal is broken; if the Laser Sheath has been damaged. When the laser sheath is in the body, it should be manipulated only under fluoroscopic observation with radiographic equipment that provides high-quality images.

Please see complete Instructions for Use before using the SLS II.