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Boston Scientific Demonstrates Ongoing Structural Heart Advances At Transcatheter Cardiovascular Therapeutics 2012 In Miami

NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) further demonstrated the strength of its structural heart program today at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation with four podium presentations showcasing the potential of the WATCHMAN ® Left Atrial Appendage Closure (LAAC) Device and the Lotus™ Aortic Valve System to provide improved treatment options for millions of patients experiencing debilitating heart disorders.  

"Through our strategic acquisitions in the structural heart space, Boston Scientific has made good progress in developing devices that advance cost-effective treatments and improve outcomes for patients," said Keith D. Dawkins, M.D., global chief medical officer at Boston Scientific. "We are pleased with the clinical results from both devices and look forward to further demonstrating the quality and effectiveness of our robust structural heart program to both patients and physicians."

Following is an overview of Boston Scientific presentations today at TCT:
  • A study by Bryan Yan, M.D., analyzed the lifetime cost‐effectiveness of the left atrial appendage (LAA) occlusion  device for preventing stroke in patients with non‐valvular atrial fibrillation.  The study found transcatheter LAA occlusion is considered a cost-effective strategy compared to aspirin, aspirin and clopidogrel, warfarin, dabigatran 150mg or 110mg for stroke prevention in patients with atrial fibrillation.
  • A sub-analysis of the PROTECT AF study lead by Saibal Kar, M.D., found atrial fibrillation patients age 75 and older had a lower risk of stroke and all-cause mortality with the WATCHMAN LAAC device than with warfarin therapy.  These results suggest that LAAC with the WATCHMAN device is a reasonable alternative to anticoagulation for patients over 75 years old.
  • Horst Sievert, M.D., reviewed results from the ASA Plavix (ASAP) Study of the WATCHMAN LAAC Device, which showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.  Earlier this year, European regulators approved an expanded indication for the WATCHMAN LAAC Device offering patients with atrial fibrillation (AF) and a contraindication to oral anticoagulants, a new treatment option for stroke reduction.
  • The REPRISE I feasibility trial demonstrated successful deployment of the Lotus Aortic Valve System in all patients, with virtually no paravalvular regurgitation through three months.  The Lotus Aortic Valve System is a second-generation transcatheter aortic valve replacement (TAVR) technology designed to simplify and improve the transcatheter aortic valve replacement procedure in patients with severe aortic valve disease.  The trial results, presented by Ian T. Meredith, M.B.B.S., Ph.D., highlighted the predictable and precise placement of the Lotus and a unique Adaptive™ Seal feature designed to minimize the incidence of paravalvular leakage.  These features will be further tested in the REPRISE II study (CE Mark trial) which commenced enrollment in October of 2012.

Wrapping up later in the week, Vivek Reddy, M.D., is scheduled to offer perspective on the potential of LAAC devices to transform the management of atrial fibrillation in a plenary session on Thursday, October 25 at 5:30 p.m.

"As observed from recent clinical trial results, it is clear to me that left atrial appendage closure devices will transform how we understand and treat atrial fibrillation," said Dr. Reddy. "Ongoing and future research will help us gain an even greater understanding of the benefits these devices can offer patients and what this means for standard atrial fibrillation treatment."

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