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Boston Scientific Announces FDA Approval of New Heart Failure Lead

Saturday, May 17, 2008 General News J E 4
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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.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements may be identified by words like "anticipate," "expect," "project,""believe," "plan," "estimate," "intend" and similar words. Theseforward-looking statements are based on our beliefs, assumptions and estimatesusing information available to us at the time and are not intended to beguarantees of future events or performance. These forward-looking statementsinclude, among other things, statements regarding our product performance,regulatory approval of our products, new product launches, competitiveofferings, our growth strategy, and our market position. If our underlyingassumptions turn out to be incorrect, or if certain risks or uncertaintiesmaterialize, actual results could vary materially from the expectations andprojections expressed or implied by our forward-looking statements. Thesefactors, in some cases, have affected and in the future (together with otherfactors) could affect our ability to implement our business strategy and maycause actual results to differ materially from those contemplated by thestatements exp
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