Spectranetics has received the Ministry of Health, Labor and Welfare approval in Japan for the Laser Sheath (SLS II) product reimbursement to hospitals, which is used for the removal of problematic pacemaker and defibrillator cardiac leads.
Spectranetics said that, through its distribution partner DVx, the initial phase of SLS II launch is expected to commence immediately and focus on establishing a limited number of lead extraction training centers.
Emile Geisenheimer, chairman, president and chief executive officer, said: “Japan represents a significant market opportunity for our products. Product reimbursement for our SLS II is an important accomplishment as it is our first product to have both regulatory and reimbursement approval in Japan.
“We have regulatory submissions pending for certain peripheral atherectomy, crossing solutions, and lead locking device products, and through our partnership with DVx, look forward to offering our full portfolio of products in the future.”
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system.