Spectranetics Receives FDA Approval for Advanced GlideLightTM Laser Sheath
COLORADO SPRINGS, Colo.--(BUSINESS WIRE)-- The Spectranetics Corporation (SPNC) today announced FDA approval of the new advanced GlideLight Laser Sheath for removal of cardiac leads. As part of the companys 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 companys 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 Companys 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.
The Companys Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.
The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These include without limitation statements regarding performance of the GlideLight product and other new product introductions. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include without limitation failure of the GlideLight product to perform as expected, lack of market acceptance of excimer laser atherectomy technology, the GlideLight product or other new products or applications, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, and the adverse impact to our business of the recently enacted healthcare reform bill and related legislation. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Companys previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
Guy Childs, Chief Financial Officer
Lippert/Heilshorn & Associates, Inc.
Don Markley or Bruce Voss
Source: Spectranetics CorporationCopyright Business Wire 2012