Spectranetics Corporation (Nasdaq:SPNC) today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for the LLD® lead locking device, which is used for the removal of pacemaker and defibrillator cardiac leads. The LLD secures leads along the entire length of their hollow inner lumen, permitting physicians to apply steady traction on the lead during the removal process.
The approval of LLD complements the prior product and hospital reimbursement approvals in Japan for the Spectranetics Laser Sheath (SLS® II).
"As an integral tool for the removal of cardiac leads, this LLD approval will benefit Japanese patients and accelerate the adoption of laser lead extraction in Japan," said Jason Hein, Senior Vice President of Sales, Marketing, and Business Development.
This technology has been used in the United States and Europe for over a decade and is an important tool to manage lead-related issues, such as infection, malfunction, and venous occlusion that may arise in the over 5 million pacing and defibrillation leads implanted in patients worldwide. The LLD has the unique capability to lock leads along their entire length as well as the unique ability to be unlocked and repositioned within the lead.
"Japan represents an important market for Spectranetics and the LLD approval is a key milestone in our commercialization efforts in Japan, supported by our distribution partner, DVx," stated Shar Matin, Senior Vice President of Operations, Product Development, and International. "Our next objective is to obtain reimbursement from the MHLW for the LLD. We also look forward to additional Vascular Intervention product approvals in Japan later this year."
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