Quattro ICD lead approved in Japan
This article was originally published in The Gray Sheet
Executive Summary
Medtronic receives approval Dec. 10 to market its Sprint Quattro defibrillator lead in Japan. The approval puts a Medtronic lead back on the Japanese market, following the recall of the firm's newer Sprint Fidelis lead on Oct. 15 that raised concerns about repercussions in that country (1"The Gray Sheet" Oct. 22, 2007, p. 3). Quattro, used in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices, has been available in the United States and Europe since 2001. Quattro will launch in Japan as soon as it receives reimbursement. Wachovia analyst Larry Biegelsen said the approval will add $35 million-$40 million to Medtronic's ICD sales estimates in the first half of 2008, taking Japanese share from competitors Boston Scientific and St. Jude Medical
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