Healthcare Industry News:  left atrial appendage 

Devices Interventional Cardiology

 News Release - October 23, 2012

Boston Scientific Demonstrates Ongoing Structural Heart Advances at Transcatheter Cardiovascular Therapeutics 2012 in Miami

Results Presented on Cost Effectiveness and Clinical Benefits for Older Patients of the WATCHMAN® left atrial appendage Closure Device; Lotus™ Aortic Valve System Feasibility Trial Results Reviewed

NATICK, Mass., Oct. 23, 2012 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (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."

The WATCHMAN and Lotus devices are investigational and not available for sale in the United States.

About Atrial Fibrillation

Atrial fibrillation affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients in AF have an increased risk of stroke due to the migration of clots formed in the LAA. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients.

About Aortic Valve Disease

Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately 3 percent of the population over age 65 and 5 percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit:

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, markets for our products, our structural heart program, regulatory approvals, clinical trials and outcomes, product performance and impact, and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Source: Boston Scientific

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