"We are pleased to present a particularly rich and diversified set of data this year at EuroPCR," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "The primary endpoint results for several trials will be presented, including the NG PROMUS trial, which evaluated our Promus PREMIER™ Stent System and the EVOLVE study two-year results, which evaluated the SYNERGY™ Stent System. We believe the results will reinforce our commitment to maintaining a leadership position in the worldwide drug-eluting stent market. We also look forward to sharing results from the REDUCE-HTN study which is evaluating our Vessix™ Renal Denervation System, a uniquely differentiated technology that offers the precision of bipolar energy delivery. In the structural heart area, we will present data from our REPRISE I and II trials which evaluate the Lotus™ Aortic Valve System designed to reduce paravalvular leakage. Finally, the set of data presented at EuroPCR includes a series of presentations on our WATCHMAN™ Left Atrial Appendage Closure device, the most clinically studied technology of its kind.
Schedule of Events
All events are Paris time and take place at the Palais des Congres.
Tuesday, May 21
PE PROVE Post-Approval Trial Results
Results from the multicenter PROMUS Element™ European Post-Approval Surveillance Trial (PE PROVE) will be presented. The session will showcase one-year outcomes in 1,010 all-comer patients treated with the PROMUS Element Everolimus-Eluting Stent System. The session will be held from 1:36p.m. to 1:43 p.m. in room 243. Speaker: R. Moreno.
Wednesday, May 22
NG PROMUS Trial Results
The first-in-human results will be presented as a late-breaking clinical trial titled, "Clinical, Angiographic and Intravascular Ultrasound Outcomes of the NG PROMUS Clinical Study Evaluating the Novel Promus PREMIER™ Everolimus–Eluting Platinum Chromium Stent System." The session will be held from 9:45a.m. to 11:45a.m. in room 243. Speaker: J. Ormiston.
EVOLVE Trial Results
Two-year clinical outcomes of the EVOLVE study will be presented as a late-breaking clinical trial from 2:10p.m. to 3:10p.m. in room 242AB. Speaker: I. Meredith.
Boston Scientific Symposium Featuring The SYNERGY™ Stent
Boston Scientific will host a symposium on its SYNERGY™ Stent technology featuring a novel bioabsorbable polymer coating. The session, chaired by I. Meredith, is named "Synchronizing polymer absorption and drug elution with the SYNERGY Stent: Implications for healing and dual antiplatelet therapy duration." The session aims to discuss the impact of the polymer on healing, and current evidence when assessing ischemic bleeding and thrombotic risks for specific patient subsets. The symposium will be held from 12:00p.m. to 1:00p.m. in room 251. Speakers: J. Escaned, T. Cuisset and K. Dawkins.
REPRISE I and II Trial Results
Two presentations will feature data from the clinical program studying the Lotus Valve System:
• REPRISE I
One-year outcomes of the REPRISE I feasibility study will be shared during an oral presentation from 11:09a.m. to 11:17a.m. in room 351. Speaker: I. Meredith.
• REPRISE II
Results of the evaluation of safety and performance of the Lotus Valve System will be presented as a late-breaking clinical trial. The session is named, "Repositionable percutaneous replacement of a stenotic aortic valve through implantation of the Lotus Valve System: 30-day outcomes for the first 60 patients." The presentation is scheduled from 3:40p.m. to 4:40p.m. in room 241. Speaker: I. Meredith.
Boston Scientific Symposium Featuring REDUCE-HTN Clinical Trial Results Boston Scientific will host a symposium titled, "Catheter-Based Renal Sympathetic Denervation, Building Momentum with the Next Generation Vessix Renal Denervation System." The symposium will be co-moderated by T.F. Luscher and F. Mahfoud, and will include presentations on the state of catheter-based renal denervation, as well an update on the REDUCE-HTN trial, a post-market surveillance study designed to evaluate the Vessix Renal Denervation System. The symposium will be held from 4:45p.m. to 6:15p.m. in room 242AB. Speakers: M. Mazor, J. Schofer, E. Wyffels and G. Grassi.
Thursday, May 23
Boston Scientific Symposium Featuring Left Atrial Appendage Closure For Stroke Prevention
Boston Scientific is scheduled to host a symposium titled, "Left atrial appendage closure for stroke prevention: What every interventional cardiologist should know." The session will be chaired by M.W Bergman. Objectives of the session are to understand the new evidence for left atrial appendage closure including the PREVAIL trial results which evaluated the Boston Scientific WATCHMAN Left Atrial Appendage Closure Device, to define patient selection and access for left atrial appendage closure and to discuss the role of left atrial appendage closure versus anticoagulation for reducing risk of stroke in atrial fibrillation especially in patients with comorbidities requiring antithrombotic therapy. The symposium is scheduled to occur from 12:00p.m. to 1:00p.m. in the Maillot room. Speakers: D. Holmes, R. Virmani and C. K. Naber.
Boston Scientific Symposium Featuring Chronic Total Occlusion
Boston Scientific is scheduled to host a symposium titled, "Contemporary coronary chronic total occlusion PCI: Integrating the hybrid approach to your practice." The session will be hosted by T. De Martini and S. Walsh. The session aims to demonstrate how tailoring coronary chronic total occlusion (CTO) crossing strategies to anatomical and morphologic characteristics can increase success, and will discuss the role of the Boston Scientific CrossBoss™ and Stingray™ Crossing and Re-entry Devices in CTO PCI. The symposium is scheduled to occur from 4:45p.m. to 6:15p.m. in Theatre Havane. Speakers: M. Carlino, S. Rinfret, J. Spratt and C. Hanratty.
Friday, May 24
SYNERGY™ Stent Oral Presentation
"SYNERGY™ Preclinical Impact of Polymer Type and Location on Stent Thrombogenicity and Endothelial Cell Coverage," from 9:33a.m. to 9:40a.m. in room 243. Speaker: M. Eppihimer.
WATCHMAN Left Atrial Appendage Closure Device Oral Presentations
- "Biology Response Following WATCHMAN and Amplatzer Cardiac Plug Implantation in a Canine Left Atrial Appendage Model," from 9:00a.m. to 9:07a.m. in room 252A. Speaker: S. Kar.
- "Efficacy and Safety of Percutaneous Left Atrial Appendage Closure in Patients with Non-Valvular Atrial Fibrillation: A Single Center Experience," from 9:44a.m. to 9:51a.m. in room 252A. Speaker: F. Al Samadi.
- "An Analysis of the Cost Effectiveness of Left Atrial Appendage Closure for the Prevention of Stroke in Patients with Atrial Fibrillation and Absolute Contraindications to Warfarin Therapy," from 10:06a.m. to 10:13a.m. in room 252A. Speaker: V. Reddy.
- "Dabigatran for Anticoagulation Following Left Atrial Appendage Closure Using the WATCHMAN Device: The ALSTER LAA Registry," from 10:17a.m. to 10:24a.m. in room 252A. Speaker: F. Meincke.
In the United States, the SYNERGY™ and PROMUS Premier Stent, Lotus Aortic Valve System and Vessix Renal Denervation System are investigational devices and are limited by applicable law to investigational use only and are not available for sale. In the European Economic area, the Lotus Valve System is an investigational device and not available for sale. The WATCHMAN device was approved for sale in Europe in 2005 and some countries in Asia in 2009. It is already commercially available in 55 countries worldwide. In the United States, the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale.
All clinical data results are embargoed until the time of each scientific presentation. Conference attendees are invited to visit Boston Scientific at booth F17 in the Exhibit Hall.
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, regulatory approvals, clinical trials, product performance 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.