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1. Comparison of average peak push forces required to advance Laser Sheath at 40 Hz vs. 80 Hz Pulse Repetition Rate through simulated fibrosis material at an advancement rate of 1.0 mm/second. D015722, Data on file at Philips.
2. Comparison of ablation force vs. advancement rate of Laser sheath 40Hz vs. 80Hz by use of the data collected in D015786, Data on file at Philips.
3. Carillo RG, Tsang DC, Azarrafiy R, Boyle TA. Multi-Year Evaluation of Compliant. Endovascular Balloon in Treating Superior Vena Cava Tears During Transvenous Lead Extraction. EHRA late-breaking trial. March 19, 2018.
4. Document on file, D026197. In an animal model with SVC tears up to 3.5 cm, with 2 pacing leads and 1 ICD lead.
5. Kusumoto et al. 2017 HRS Expert Consensus Statement on Cardiovascular. Implantable Electronic Device Lead Management and Extraction. Heart Rhythm, 2017.
6. Sohail, M Rizwan, et al. Incidence, Treatment Intensity, and Incremental Annual Expenditures for Patients Experiencing a Cardiac Implantable Electronic Device Infection: Evidence From a Large US Payer Database 1-Year Post Implantation. Circ Arrhythm Electrophysiol. 2016; 9(8).
7. Maytin M, Jones SO, Epstein LM. Long-Term Mortality After Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2012;5:252-257.
8. Pokorney et al. Outcomes Associated with Extraction versus Capping and Abandoning Pacing and De brillator Leads Circulation 2017 Oct 10;136(15):1387-1395. doi: 10.1161/CIRCULATIONAHA.117.027636. Epub 2017 Aug 22.
9. Sohail, M. et al. (2014). Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction. Europace, 16(1), 81-87.
10. Oginosawa Y, Abe H, Nakashima Y. The incidence and risk factors for venous obstruction after implantation of transvenous pacing leads. Pacing Clin Electrophysiol 2002;25:1605–1611.
11. Kutarski, A., Pietura, R., Młynarczyk, K., Małecka, B., & Głowniak, A. (2012). Pacemaker lead extraction and recapture of venous access: technical problems arising from extensive venous obstruction. Cardiology journal, 19(5), 513-517.
12. Mattei, E., Gentili, G., Censi, F., Triventi, M. and Calcagnini, G. (2015), Impact of capped and uncapped abandoned leads on the heating of an MR-conditional pacemaker implant. Magn Reson Med, 73: 390–400. doi: 10.1002/mrm.25106
13. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4):326-328.
14. Wazni, O et. al. Lead Extraction in the Contemporary Setting: The LExICon Study: A Multicenter Observational Retrospective Study of Consecutive Laser Lead Extractions, J Am Coll Cardiol, 55:579-586
15. de Cock CC, et al. Long-term outcome of patients with multiple (> or = 3) noninfected leads: a clinical and echocardiographic study. PACE, Vol 23, No 4, 2000, 423-6.
GlideLight Laser Sheath
GlideLight Laser Sheath Important Safety Information
Indications for Use
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.
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.
Potential Adverse Events
The following adverse events or conditions may also occur during lead extraction with the Laser Sheath, but were not observed during the clinical study (listed in alphabetical order): bacteremia, low cardiac output, migration of lead fragments, migration of vegetation, myocardial avulsion/perforation, premature ventricular contractions, pulmonary embolism, stroke, venous avulsion/perforation, ventricular tachycardia.
Caution: Federal law restricts this device to sale by or on the order of a physician.