Spectranetics Receives FDA Approval for Advanced GlideLight Laser Sheath
May 2, 2012 — The Spectranetics Corp. announced U.S. Food and Drug Administration (FDA) approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads. As part of the company’s vision to safely manage every lead, GlideLight delivers more precise control to reduce the force for safe lead extraction.
Spectranetics’ current laser sheath, the SLS II, requires significantly less force to advance than mechanical telescoping sheaths. GlideLight is a major leap forward, requiring 55 percent less force to advance than SLS II.
“Mechanical force is a leading cause of complications during lead extraction,” said Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic and a nonpaid member of Spectranetics’ Medical Advisory Board. “[R]educed force improves the control for safely removing leads. It is particularly important to have control when breaking up tough binding sites.”
“GlideLight has taken us to the next level in lead extraction,” said Charles Kennergren, professor at Sahlgrenska University Hospital in Gothenburg, Sweden, and the first physician to use GlideLight clinically. “I am very impressed with the reduced force and increased control and efficiency that GlideLight has provided me.”
A limited market release of GlideLight will be conducted to gain early experience prior to a broader controlled launch. GlideLight will be the company’s focus at the Heart Rhythm Society meeting in Boston May 9-11.
For more information: www.spectranetics.com