OREANDA-NEWS. March 25, 2016. Boston Scientific (NYSE: BSX) today announced key data presentations spanning its interventional cardiology, rhythm management and structural heart portfolios, that will be featured at the American College of Cardiology's 65th Annual Scientific Session which will be held in Chicago, April 2-4.

Scheduled abstracts will highlight 'real-world' and clinical trial experiences with technologies developed to treat patients with a range of cardiovascular diseases. Topics to be presented include:

  • One-year post U.S. Food and Drug Administration (FDA) approval experience using the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device to reduce the risk of stroke in people with non-valvular atrial fibrillation who cannot take warfarin.
  • Two-year safety and efficacy outcomes with the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System in patients with coronary artery disease from the EVOLVE II trial.
  • Performance and clinical outcomes of the Lotus™ Transcatheter Aortic Valve Replacement (TAVR) System in patients with severe calcific aortic stenosis from the RESPOND trial.
  • First-ever pre-clinical data evaluating the Boston Scientific modular therapy approach and communications compatibility between its leadless pacemaker and the EMBLEM™ subcutaneous implantable defibrillator (S-ICD).
  • Primary results of the NAVIGATE X4 study, the multi-center clinical trial that led to the FDA approval of ACUITY™ X4 Quadripolar left ventricular (LV) leads in February 2016.

"This is a unique congress for us, as we have the opportunity to present new data supporting a number of our key cardiology products which have received FDA approvals since ACC 2015," said

Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "We are also looking forward to unveiling the first data from our leadless pacemaker program, as well as contributing to discussions on the future of transcatheter aortic valve replacement."

Abstracts of Interest (listed chronologically within product categories)

Interventional Cardiology

  • SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System: Late Clinical Outcomes After Bioabsorbable or Permanent Polymer Everolimus-Eluting Stents: 2-Year Results From the EVOLVE II Randomized Trial:

    Dean Kereiakes, M.D., will present on Sunday, April 3 at 1:00 PM in the ACC.i2 IC Moderated Poster Theater, South Hall A.

Rhythm Management

  • ACUITY™ X4 Quadripolar LV leads: Clinical Performance of Physiologically Designed Quadripolar Left Ventricular Pacing Leads: Primary Results from the NAVIGATE X4 Clinical Trial:

    Suneet Mittal, M.D., will present on Sunday, April 3 at 3:45 PM in the Poster Area, South Hall A1.

  • Leadless pacemaker used with the EMBLEM S-ICD System: The First Report on Communicating Leadless Anti-Tachycardia Pacemaker and S-ICD: The Next Step in Cardiac Rhythm Management:

    Fleur Tjong, M.D., will present on Monday, April 4 at 9:45 AM in the Arrhythmias and Clinical EP Moderated Poster Theater, South Hall A.

Structural Heart

  • The Lotus Valve System: Feasibility of Direct Aortic Implantation of the Lotus Valve: a Multicenter Experience: Leo Ihlberg, M.D., Ph.D., will present on Saturday, April 2 at 10:00 AM in the Valvular Heart Disease Moderated Poster Theater, South Hall A.
  • WATCHMAN Device: Post-FDA Approval Experience of LAAC in the United States:

    David R. Holmes, M.D., will present on Saturday, April 2 at 10:45 AM in the Arrhythmias and Clinical EP Moderated Poster Theater, South Hall A.

  • The Lotus Valve System: Outcomes With Predilatation Versus No Predilatation in Routine Clinical Practice With the Lotus Valve: Results From the First 500 Patients Enrolled in the RESPOND Study:

    Nicolas Van Mieghem, M.D., will present on Saturday, April 2 at 4:15 PM in the Valvular Heart Disease Moderated Poster Theater, South Hall.

  • The Lotus Valve System: Post-Market Evaluation of a Fully Repositionable and Retrievable Aortic Valve in 750 Patients Treated in Routine Clinical Practice: An Update From the RESPOND Study:

    Nicolas Van Mieghem, M.D., will present on Monday, April 4 at 8:15 AM in Room S405.

All programs are listed in Central Time and will take place at the Chicago McCormick Place Convention Center. For more information, visit Boston Scientific at booth #12026.

The company will also host an investor event and webcast on April 4 from 7:00 – 8:00 AM CDT to provide a presentation and answer questions from investors about the Boston Scientific cardiovascular portfolio. The event will be accessible via live webcast at www.bostonscientific.com/investors. A replay of the webcast will be accessible at www.bostonscientific.com/investors beginning approximately one hour following the completion of the event.

Caution: The Lotus Valve System is an investigational device limited under U.S. Federal law to investigational use only and not available for sale in the U.S. The leadless pacemaker is a concept device or technology. Not available for use or sale.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.  For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

About the American College of Cardiology

The American College of Cardiology Annual Scientific Session brings together cardiologists and cardiovascular specialists from around the world each year to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC16 for the latest news from the meeting. The American College of Cardiology is a 49,000-member medical society that serves as the professional home for the entire cardiovascular care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, clinical standards and practice guidelines. The College operates national registries to measure and improve care. It also provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit www.acc.org.