The Spectranetics Corporation has received approval from the U.S. Food and Drug Administration for its new GlideLight Laser Sheath, used for the removal of cardiac leads.
The GlideLight is touted to deliver precise control, reducing the need for excess force to be exerted, making lead extraction safer. GlideLight is effectively the second-generation version of Spectranetics’ existing device, the SLS II. According to the company, GlideLight requires 55 percent less force to operate than the SLS II.
“Mechanical force is a leading cause of complications during lead extraction,” said Bruce Wilkoff, M.D., director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, “and reduced force improves the control for safely removing leads. It is particularly important to have control when breaking up tough binding sites.” Wilkoff is a non-paid member of Spectranetics’ medical advisory board.
The first person to use the device proved satisfied by its performance: Dr. Charles Kennergren, professor at Sahlgrenska University Hospital in Gothenburg, Sweden, said that he is “very impressed with the reduced force and increased control and efficiency that GlideLight has provided [him].”
GlideLight will be released on a broad, controlled scale only after it goes through a limited market release to gain early experience.
Spectranetics is based in Colorado Spring, Colo., and provides single-use medical devices used in minimally invasive procedures within the cardiovascular system.