NATICK, Mass., May 16 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX - News) today announced U.S. Food and Drug Administration (FDA) approval of its ACUITY® Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators (CRT-D) and cardiac resynchronization therapy pacemakers (CRT-P), both of which treat heart failure. The ACUITY Spiral lead is the Company’s fifth generation left ventricular lead and second in the ACUITY family of left ventricular leads. The product features a spiral fixation design and small lead tip profile (4.1 French tapering to 2.6 French) for placement of the lead in veins of varying sizes, including difficult-to-access veins. A lead is an insulated wire that carries the heart signal to the implanted device and delivers energy from the device to the heart. In most cases, leads are passed into the heart through veins.
“In the U.S. clinical trial, the ACUITY Spiral fixation design provided excellent stability after implant,” said John Hummel, M.D., principal investigator of the ACUITY Spiral U.S. clinical trial. “ACUITY Spiral has the smallest left ventricular lead tip profile in the industry, offering greater flexibility to place the lead in veins I may have avoided in the past.”
Boston Scientific is also conducting a prospective, multi-center trial designed to collect and analyze real-world performance data for the ACUITY Spiral lead. The study will enroll approximately 1,700 patients in up to 125 centers. Patients will be followed over a period of five years and will be enrolled on Boston Scientific’s LATITUDE® Patient Management system, enabling wireless remote management of patients.
“This study demonstrates Boston Scientific’s commitment to quality and robust post-market surveillance of new leads,” said Arjun Sharma, M.D., Vice President, Patient Safety, Boston Scientific CRM. “The data from this post- market study will provide us with a deeper understanding of the lead’s performance in real-world practice and will be a welcome addition to the data we collected from the U.S. clinical trial.”
Boston Scientific is the only company to offer four fixation designs that provide stability in a variety of venous anatomies, enabling physicians to select the most appropriate lead for their patients. The ACUITY Spiral lead is 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 of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation
Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
Source: Boston Scientific Corporation
