FDA OKs Spectranetics’ GlideLight Laser Sheath

Single-use medical device developer Spectranetics Corp. announced Wednesday that its GlideLight Laser Sheath for the removal of cardiac leads had received FDA approval.

GlideLight delivers more precise control to reduce the force for safe lead extraction. It requires 55 percent less force to advance than the company’s current laser sheath, SLS II, which needs less force to advance than mechanical telescoping sheaths.

“Mechanical force is a leading cause of complications during lead extraction, and reduced force improves the control for safely removing leads,” said Dr. Bruce Wilkoff, director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, and a nonpaid member of Spectranetics’ medical advisory board. “It is particularly important to have control when breaking up tough binding sites.”

A limited market release of the device will be conducted to gain early experience prior to a broader controlled launch. It will be demonstrated May 9-11 at the Heart Rhythm Society meeting in Boston.

For more information, visit: www.spectranetics.com