August 29, 2008 -- Spectranetics Corporation (Colorado Springs, CO; Nasdaq: SPNC) has announced the first use in Japan of its Spectranetics Laser Sheath (SLS II) technology for removal of cardiac leads. Approved by the Ministry of Health, Labor and Welfare, the SLS II is one of just three medical device technologies chosen annually under a fast track review in Japan.
This technology has been used in the U.S. and Europe for over a decade in more than 45,000 procedures and is an important tool to manage lead-related issues that may arise in the roughly 4 million pacing and defibrillation leads implanted annually in patients worldwide. Use of such technology is growing steadily.
The SLS II uses "cool" ultraviolet light to safely, effectively and efficiently ablate scar tissue that holds problematic leads in place. A circle of fibers that emit pulses of energy travels over the cardiac lead to dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed. Spectranetics is also in the process of seeking approval of the Lead Locking Device (LLD) technology in Japan, which can be used to assist removal with the SLS II by transmitting traction on the lead from within its hollow inner structure.
Two procedures were recently performed at Tokyo Women's Medical University by Dr. Morio Shoda, Chief of Clinical Cardiac Electrophysiology and Associate Professor of Cardiology, and Dr. Satoshi Saito, Assistant Professor of Cardiovascular Surgery, under the proctorship of Dr. Roger Carrillo, the Director of Surgical Electrophysiology at the University of Miami. Both cases involved leads that were infected, and all leads were successfully removed from the heart and encapsulating scar tissue using the SLS II Laser sheath without complication.
Dr. Roger Carrillo said, "In my years of experience with lead extraction procedures, the laser sheath is an indispensable tool that has helped me remove leads in a very safe, effective and efficient manner in hundreds of patients. In this first case in Japan, the laser sheath was successful in extracting a chronic lead where all other techniques had previously failed."
"Japan is an important market for Spectranetics and the recent fast track approval for our SLS II Laser Sheath is a key first step towards commercialization in Japan, supported by our distribution partner, DVx Japan. We will launch this technology commercially following reimbursement approval for the SLS II, which is currently under review by Japan's Ministry of Health, Labor and Welfare," said Spectranetics CEO John Schulte.