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Full article reprinted from "The Gray Sheet"- February 22, 2010 FDA's Circulatory System Devices advisory panel will weigh in on two closely watched approval decisions at a March 18-19 meeting. Read more... |
Boston Scientific, Medtronic Heart Devices Go To Panel In March
Full article reprinted from "The Gray Sheet"- February 22, 2010
FDA's Circulatory System Devices advisory panel will weigh in on two closely watched approval decisions at a March 18-19 meeting. On day one, the panel will vote on whether FDA should approve expanded labeling for Boston Scientific's line of cardiac resynchronization therapy defibrillators (CRT-Ds) to include a substantially broader population of heart failure patients. On day two, the expert advisors will help the agency decide whether to allow Medtronic to market a pacemaker that would be the first in the U.S. that could be safely used with magnetic resonance imaging machines. Boston Scientific's CRT-D Hopes Boston Scientific will present data from the 1,820-patient MADIT-CRT trial, published in the New England Journal of Medicine last year, showing CRT-Ds to be significantly more effective than conventional implantable cardioverter defibrillators in reducing the risk of heart-failure events - such as hospitalization for symptoms of congestive heart failure - for Class I and II heart failure patients. Currently, CRT-D devices are only approved for Class III and IV heart failure patients, though the earlier-stage, relatively asymptomatic Class I and II patients represent about 70% of the heart failure population. Boston Scientific expects FDA approval of the expanded labeling by mid-year. Analysts say the new labeling could give a modest boost to the market for CRT-Ds, which are sold at a premium to regular ICDs, but the major impact will come when the new indication is put into clinical guidelines and receives reimbursement. In any case, the approval would be a major positive for Boston Scientific's challenged cardiac rhythm management business and for the overall sluggish CRM market (The Gray Sheet' Feb. 15, 2010). Medtronic's MRI-Safe Bet Medtronic, meanwhile, will present data on its MRI-safe pacemaker, which FDA referred to as the Revo MRI pacemaker system in a Feb. 18 Federal Registe notice. "The Revo MRI pacing system is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions," FDA writes. Medtronic has not previously announced and would not confirm the name of the device. Patients with currently available pacemaker and defibrillator implants are discouraged from receiving an MRI scan because of the potential for electromagnetic interference with the device, the firm notes. In addition, MRI scans have caused burns and other tissue damage in patients with the devices, according to adverse event reports (The Gray Sheet' May 8, 2006). The company estimates that there are more than two million U.S. patients who cannot have an MRI because they have an implanted cardiac device. Medtronic already markets the only imaging-safe pacemaker in Europe - EnRhythm - and hopes to launch its new Advisa MRI-compatible pacemaker there later this year. According to a Medtronic spokeswoman, the latest design has a different battery configuration from EnRhythm and Advisa. But the spokeswoman indicated that FDA will review data from the 464-patient EnRhythm MRI SureScan trial, which showed that patients implanted with the pacemaker who underwent an MRI scan fared the same as patients who received no scan (The Gray Sheet' May 25, 2009). Medtronic is expected to take the lead in the MRI-safe pacing environment, but St. Jude Medical also expects to launch an MRI-compatible pacemaker in Europe this year (The Gray Sheet' Feb. 1, 2010). - Jessica Bylander
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