Boston Scientific Announces FDA Approval of New Heart Failure Lead
"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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