The Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for Spectranetics’ LLD lead locking device, to treat arterial blockages in the heart and legs as well as the removal of pacemaker and defibrillator leads.
The approval of LLD complements the prior product and hospital reimbursement approvals in Japan for the Spectranetics Laser Sheath (SLS II).
The LLD secures leads along the entire length of their hollow inner lumen, permitting physicians to apply steady traction to manage lead-related issues, such as infection, malfunction, and venous occlusion.
Operations, Product Development and International senior vice president Shar Matin said Japan represents an important market for Spectranetics and the LLD approval is a key milestone in their commercialization efforts in Japan, supported by their distribution partner DVx.
"Our next objective is to obtain reimbursement from the MHLW for the LLD. We also look forward to additional Vascular Intervention (VI) product approvals in Japan later this year," Matin said.
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system.
The company’s 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.
Spectranetics also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.