Clinical Technique - Spectranetics LLD Instrucciones De Uso

Spectranetics Lead Cutter or other suitable instrument, expose the inner coil of the
lead.
NOTE: For a unipolar lead, if the lead is long enough, use a scalpel to circumscribe
the insulation two centimeters from the cut proximal end of the lead (do this
carefully to avoid deforming the coil), then pull the insulation off to expose the inner
coil.
For a bipolar lead with coaxial coils, remove the outer coil and inner insulation to
expose the inner coil and prevent it from being pushed deeply into the outer coil.
Once the inner lumen of the lead is exposed, insert the Spectranetics Coil
Expander to ensure that there is no obstruction to insertion of the Spectranetics Pin
Gauges used to size the appropriate LLD.
NOTE: Examine the lumen to be sure the interior coil is not flattened and there are
no burrs that would inhibit passage of the Spectranetics Pin Gauges or the LLD
into the lumen.
2. Determine the appropriate size of LLD based on the inside diameter of the lead coil.
The Spectranetics Pin Gauges are used to determine the inner diameter of the
coil. The size of the largest pin that fits freely in the coil indicates the size of the
appropriate LLD.
3. Check patency of the coil lumen. Pass the Clearing Stylet (provided in the LLD
package) through the inner lumen of the lead to clear any blood, coagulation, or
blockage in the lumen prior to insertion of the LLD. After confirmation of a clear
lumen, remove the Clearing Stylet.
NOTE: It may be helpful to mark the depth of penetration of the Clearing Stylet into
the lead by placing a mosquito clamp at that point where the Clearing Stylet exits
the cut end of the lead. Knowing the depth of penetration will be useful later in
monitoring progress during insertion of the LLD.
4. Grasp the appropriately sized LLD within the mesh section and advance the LLD
into the inner coil of the lead, using the radiopaque marker for fluoroscopic
monitoring.
Caution: Do not attempt to advance or rotate the LLD via the proximal connector as
premature deployment or damage to the mesh may result.
Caution: Do not attempt to rotate the LLD via the proximal loop as damage to the
device may result.
5. Lock the LLD in place by:
Releasing the proximal connector from the crimped core mandrel by sliding the
connector off the crimped section after the LLD has reached the distal end of the
lead or the position indicated by the Clearing Stylet.
This action expands the wire mesh inside the lead and locks it in place (the device
is now deployed). Tension can be applied to the core mandrel or proximal loop for
traction.
6. It is recommended that a suture be tied to the proximal end of the targeted lead
insulation as an additional traction source. The other end of the suture can be
secured to the LLD via the Distal Loop immediately above the Proximal Connector.
Fastening the suture to the Distal Loop will facilitate the insertion of the LLD with
the suture through the Spectranetics Laser Sheath. Closely follow the Instructions
for Use for the Spectranetics Laser Sheath Kit.
7. If for some reason lead removal is unsuccessful or becomes medically
contraindicated, removal or repositioning of the LLD may be facilitated as follows:
Reset the proximal connector onto the crimped section of the core mandrel.
This action reduces the diameter of the wire mesh inside the lead, unlocking it from
the inner lead body.
Withdraw or reposition the LLD by grasping the proximal mesh of the locking
device.
If the LLD is still secured within the lead the following actions are recommended:
A. Grasp the mesh near the proximal end of the lead coil and gently smooth the
mesh by stretching it towards the proximal connector.
B. Grasp the mesh again near the proximal end of the lead coil, advance the
LLD within the lead and then simultaneously rotate and pull the LLD from the
lead body.
9.1

Clinical Technique

Thoroughly review appropriate package inserts for Spectranetics Laser Sheaths or
other necessary lead extraction tools before attempting to use the LLD.
Manufacturer's Limited arranty
10.
Manufacturer warrants that the LLD is free from defects in material and workmanship
when used by the stated ―Use By‖ date and when package is unopened and
undamaged immediately before use. Manufacturer's liability under this warranty is
limited to replacement or refund of the purchase price of any defective LLD.
Manufacturer will not be liable for any incidental, special, or consequential damages
resulting from use of the LLD. Damage to the LLD caused by misuse, alteration,
improper storage or handling, or any other failure to follow these Instructions for Use
will void this limited warranty. THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU OF
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
No person or entity, including any authorized representative or reseller of Manufacturer,
has the authority to extend or expand this limited warranty and any purported attempt to
do so will not be enforceable against Manufacturer.
P 0 0 4 7 7 7 - 0 2
1 3 D e c 1 1
( 2 0 1 1 - 1 2 - 1 3 )
B
IBLIOGRAPHY
Furman, S.: Removal of Implanted Hardware: PACE May 1991, Part I: 14:755
Byrd, C. L., Schwartz, S, Hedin, N.: Lead Extraction: Cardiology Clinics November
1992: 10 (4): 735-748
Epstein, A. E., et. al.: Personal and Public Safety Issues Related to Arrhythmias That
May Affect Consciousness... A Medical/Scientific Statement From the AHA and
NASPE, May 10, 1994 Policy Conference
Wilkoff, B. L., et. al.: Seven Year Single Center Analytical Experience of Transvenous
Lead Extraction. NASPE Abstract, PACE April 1996
Berstein, A., Parsonnet, V.: Pacing Practices in the United States, NASPE Abstract,
PACE April 1996
Berstein, A., Parsonnet, V.: Pacing Practices in the United States (Updated), Heart
Web Abstract, June 1996
Helguera, M., Meierhenrich, R, Wilkoff, B., Morant, V., Tchou, P., Pinski, S., Cleveland
Clinical Foundation: Medium-Term Performance of the Endotak Lead, NASPE
Abstract, PACE April 1996
Byrd, C. L.: Extracting Chronically Implanted pacemaker Leads using the Spectranetics
Excimer Laser; Initial Clinical Experience: NASPE Abstract, PACE April 1996
Byrd, C. L.: Laser System Improves Success at Removing pacemaker Leads: NASPE
News Brief (Abstract #1687), PACE April 1996
Byrd, C. L.: Extraction of Telectronics 330-808 and 329-701 Leads, NASPE Abstract,
PACE April 1996
Smith, H. J., et. al.: Five-Year Experience with Intravascular Lead Extraction: PACE
1994:17:2016-2020
Safety and Efficacy Report on the 12 Fr Spectranetics Laser Sheath, FDA publication,
July 1998
® ®
Spectranetics Laser Sheath (SLS
Non-Standard Symbols
Non-Pyrogenic
Lead Internal Diameter Range
Size
Pin Gauge
)Instructions For Use
Kit Includes
Clearing Stylet Outer Diameter
Contents
Coil Expander
5/94