NATICK, Mass., May 16 Boston ScientificCorporation (NYSE: BSX) today announced U.S. Food and Drug Administration(FDA) approval of its ACUITY(R) Spiral left ventricular lead for use withcardiac resynchronization therapy defibrillators (CRT-D) and cardiacresynchronization therapy pacemakers (CRT-P), both of which treat heartfailure. The ACUITY Spiral lead is the Company's fifth generation leftventricular lead and second in the ACUITY family of left ventricular leads.The product features a spiral fixation design and small lead tip profile (4.1French tapering to 2.6 French) for placement of the lead in veins of varyingsizes, including difficult-to-access veins. A lead is an insulated wire thatcarries the heart signal to the implanted device and delivers energy from thedevice to the heart. In most cases, leads are passed into the heart throughveins.
"In the U.S. clinical trial, the ACUITY Spiral fixation design providedexcellent stability after implant," said John Hummel, M.D., principalinvestigator of the ACUITY Spiral U.S. clinical trial. "ACUITY Spiral has thesmallest left ventricular lead tip profile in the industry, offering greaterflexibility to place the lead in veins I may have avoided in the past."
Boston Scientific is also conducting a prospective, multi-center trialdesigned to collect and analyze real-world performance data for the ACUITYSpiral lead. The study will enroll approximately 1,700 patients in up to 125centers. Patients will be followed over a period of five years and will beenrolled on Boston Scientific's LATITUDE(R) Patient Management system,enabling wireless remote management of patients.
"This study demonstrates Boston Scientific's commitment to quality androbust post-market surveillance of new leads," said Arjun Sharma, M.D., VicePresident, Patient Safety, Boston Scientific CRM. "The data from this post-market study will provide us with a deeper understanding of the lead'sperformance in real-world practice and will be a welcome addition to the datawe collected from the U.S. clinical trial."
Boston Scientific is the only company to offer four fixation designs thatprovide stability in a variety of venous anatomies, enabling physicians toselect the most appropriate lead for their patients. The ACUITY Spiral leadis designed for use with heart failure devices, such as the COGNIS(TM) CRT-D,which received FDA approval earlier this week.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
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