The Spectranetics Corporation (NASDAQ: SPNC) today announced 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% less force to advance than SLS II.
“Mechanical force is a leading cause of complications during lead extraction,” said Dr. Bruce Wilkoff, 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.” Dr. Wilkoff is a non-paid member of Spectranetics’ Medical Advisory Board.
“GlideLight has taken us to the next level in lead extraction,” said Dr. Charles Kennergren, professor at Sahlgrenska University Hospital in Gothenburg, Sweden, and first physician worldwide to use GlideLight clinically. “I am very impressed with the reduced force and increased control and efficiency that GlideLight has provided me.”
“GlideLight demonstrates our commitment to innovate and deliver solutions for safe, predictable outcomes,” said Scott Drake, Spectranetics CEO and President. “This is one of the many meaningful advancements we plan to deliver to achieve our vision.”
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, where physicians will be able to experience the GlideLight difference first-hand at the Spectranetics exhibit.
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold in more than 40 countries and are used to treat arterial blockages in the heart and legs, as well as the removal of pacemaker and defibrillator leads.