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Safe Options for Cardiac Lead Removal: Study Published in Heart Rhythm Journal
Date:5/12/2008

Spectranetics' Laser System Successfully Assists Removal of 975 Cardiac

Leads

COLORADO SPRINGS, Colo., May 12 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC) today announced that a peer-reviewed study demonstrates Spectranetics' excimer laser sheath safely and effectively assists removal of pacing and defibrillator leads. The study, "Large, Single- catheter, Single-operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications," featured in the April issue of HeartRhythm, represents a seven year retrospective analysis of data from 498 lead extraction procedures involving 975 leads. The conclusion demonstrates safe extraction of leads successfully removed with laser assistance. HeartRhythm is the official journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society.

As an escalating number of patients receive implanted cardiac devices, concerns surrounding lead management options are on the rise. Infection continues to be a primary cause for concern with leads, however, lead malfunction and patient lifespan are increasingly encouraging physicians to consider lead removal versus lead abandonment, the previous standard-of-care practice. Historically, safe, effective technologies designed to assist lead removal were limited but this is changing as new technologies enter the market and continue to receive clinical validation.

The Spectranetics Laser Sheath (SLS(R) II) use "cool" ultraviolet light to safely, effectively and efficiently ablate scar tissue that holds problematic leads in place. A circle of fibers that emit pulses of energy travel over the cardiac lead towards the tip to dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed. Spectranetics' Lead Locking Device (LLD) technology can also be used to assist removal by creating secure traction during procedures that may or may not require laser assistance.

The retrospective study at Brigham and Women's Hospital in Boston was designed to examine indications, outcomes and complications associated with transvenous lead extraction. Dr. Laurence Epstein, Chief of Cardiac Arrhythmia Services at Brigham and Women's Hospital acted as the single-operator in the study handling all 498 lead extraction procedures throughout the seven year period. The study showed a success rate of over 97% with only two major complications, and no deaths. These two major complications out of 498 procedures resulted in a major complication rate of only 0.4%. The published article also highlights concerns surrounding existing formal recommendations for lead removal given the technologies available to assist the process. The article notes that "the rate of complications from abandoned leads reported in one study was as low as 5.5 percent, which still is higher than the complication rate from extraction."

"We were interested in reviewing our outcomes, at a high volume center with an experienced operator," said Dr. Epstein. "Historically the indications for lead extraction have been tempered by the risks, real and perceived, associated with the procedure. This study demonstrates that transvenous lead extraction can be performed safely and effectively in a wider population of patients." Dr. Epstein further describes his strategy, explaining, "Hopefully, this will reduce the number of patients subjected to open heart procedures and the risks and complications of abandoned leads. However, this is not an endorsement for the performance of extraction, more widely, in inexperienced hands. Excellent results are achieved through careful preparation, planning and experience."

About Spectranetics

Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company's disposable catheters use high-energy "cool" ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information, visit http://www.spectranetics.com.

Stacey Holifield/Krystin Hayward

Schwartz Communications, Inc.,

(781) 684-0770

spectranetics@schwartz-pr.com


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SOURCE Spectranetics Corporation
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