FRAMINGHAM, Mass., April 20, 2016 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced a series of scientific presentations, highlighting the clinical and commercial use of the HVAD® System, at the International Society for Heart and Lung Transplantation (ISHLT) 36th Annual Meeting and Scientific Sessions to be held at the Marriott Wardman Park Hotel in Washington, D.C. on April 27-30, 2016.
Key Oral Presentations
"Temporal Changes in Adverse Events in the ENDURANCE Trial"
C. A. Milano, F. D. Pagani, A. J. Tatooles, N. A. Mokadam, J. Miller, T. C. Wozniak, C. H. Selzman, K. Leadley, K. D. Aaronson, J. G. Rogers
Presenter: Dr. Milano (Duke University School of Medicine)
Thursday, April 28 at 10:30 a.m. ET
"Impact of Baseline Measures and Adverse Events on Functional Assessments in the ENDURANCE Destination Therapy Trial"
J. G. Rogers, C. A. Milano, S. V. Pamboukian, G. Bhat, E. J. Birks, S. S. Najjar, B. B. Reid, D. Meyer, K. Leadley, F. D. Pagani
Presenter: Dr. Rogers (Duke University School of Medicine)
Thursday, April 28 at 2:00 p.m. ET
"Less-Invasive Left Ventricular Assist Device Implantations: Experience After More Than 100 Treated Patients"
J. D. Schmitto, S. V. Rojas, M. Avsar, J. S. Hanke, A. Uribarri, D. Burkhoff, K. Tümler, P. Ahrens, U. Molitoris, A. Martens, D. Berliner, J. Bauersachs, M. Shrestha, S. Cebotari, M. Strueber, A. Haverich
Presenter: Dr. Schmitto (Hannover Medical School, Germany)
Thursday, April 28 at 5:00 p.m. ET
"HVAD Waveform as a Surrogate Marker of Cardiac Index and Pulmonary Capillary Wedge Pressure"
J. Grinstein, D. E. Rodgers, S. Kalantari Tannenbaum, S. Adatya, N. Sarswat, G. H. Kim, G. Sayer, T. Ota, V. Jeevanandam, V. Mor-Avi, D. Burkhoff, N. Uriel
Presenter: Dr. Grinstein (University of Chicago)
Friday, April 29 at 10:45 a.m. ET
HeartWare Scientific Symposiums
In conjunction with the ISHLT Annual Meeting, HeartWare will host two symposiums for clinicians:
HVAD Pump Waveforms: Real-Time, Non-Invasive Monitoring
Wednesday, April 27, 3:50 p.m. – 4:50 p.m.; Washington Ballroom 3
Moderators: Prof. Chris Hayward (St. Vincent's Hospital, Sydney, Australia); Dr. Mark Slaughter (Jewish Hospital, Louisville)
Presenters: Dr. Samer Najjar (Washington Hospital Center); Prof. Daniel Zimpfer (Medical University Vienna, Austria) and Dr. Jeffrey Teuteberg (University of Pittsburgh Medical Center)
Advancements in HVAD Outcomes
Thursday, April 28, 12:55 p.m. – 1:55 p.m.; Washington Ballroom 3
Moderators: Dr. Jennifer Cowger, (St. Vincent Hospital, Indianapolis); Prof. Michiel Morshuis (Bad Oeynhausen, Germany)
Presenters: Dr. Ed McGee (Loyola University Medical Center); Dr. Carmelo Milano (Duke University School of Medicine) and Prof. Stephan Schueler (Newcastle Hospital, U.K.)
"HeartWare will have a strong and positive presence at this important scientific conference that attracts thousands of renowned cardiovascular clinicians from around the world," said Katrin Leadley, M.D., Chief Medical Officer of HeartWare International. "We are honored that the HVAD System is the subject of more than 90 abstracts, reinforcing the real-world, commercial experience, while highlighting the utility and versatility of the device."
Additional Oral Presentations and Scientific Posters Highlighting the HVAD System
"Incidence and Outcomes After Stroke on Rotary Flow Ventricular Assist Device Support" (poster presentation)
M. Bishawi, J. Joseph, B. Yerokun, D. Ranney, P. Winterton, J. Schroder, M. Daneshmand, D. Bowles, J. Rogers, C. Milano
Wednesday, April 27 at 6:00 p.m. ET
"Global Experience With the HeartWare HVAD in Pediatric Patients: A Preliminary Analysis"
J. Conway, O. Miera, H. T. Henderson, C. VanderPluym, H. Buchholz, M. Fenton, R. A. Niebler, M. Padalino, M. Slaughter, A. Lorts, M. Schweiger, M. Hassan, J. D. Schmitto, J. N. Scheel, B. Martin, Y. Li, P. E. Parrino, D. L. Morales, R. Kirk
Thursday, April 28 at 4:00 p.m. ET
"Lessons Learned From Over 250 Continuous-Flow Centrifugal Left Ventricular Assist Device Implantation: Growing Experience and Outcomes in Alternative Approaches Era"
S. Maltais, N. Haglund, P. Shah, J. Cowger, K. A. Aaronson, F. Pagani, S. Dunlay, J. M. Stulak
Thursday, April 28 at 4:45 p.m. ET
"Minimally Invasive HeartWare HVAD Implantation With Outflow Graft Anastomosis to the Left Subclavian Artery" (poster presentation)
J. Riebandt, D. Wiedemann, T. Haberl, T. Schloeglhofer, R. Moayedifar, K. Dimitrov, G. Laufer, D. Zimpfer
Thursday, April 28 at 6:00 p.m. ET
"Increased Risk of Gastrointestinal Bleeding in HeartMate II Compared to HeartWare Left Ventricular Assist Devices - A Single Center Retrospective Cohort"
W. T. Love, G. M. Zawadowski, J. Noelting, J. L. Horsley-Silva, L. L. Staley, M. E. Amity, L. Schroedl, M. D. Crowell, B. W. Hardaway, F. C. Ramirez, O. E. Pajaro.
Thursday, April 28 at 6:50 p.m. ET
"Invasive Hemodynamic Ramp Test: A Comparison of Ventricular Unloading Between Current Generation Continuous-Flow LVADs"
K. Abdullah, N. Badoe, S. Phillips, J. Nabut, R. Singh, S. S. Desai, P. Shah
Friday, April 29 at 10:30 a.m. ET
"Minimally Invasive Exchange of the HeartMate II (HMII) Left Ventricular Assist Device (LVAD) to the Intrapericardial HeartWare Ventricular Assist Device (HVAD)"
B. Soleimani, B. Burk, E. Stephenson, W. Pae
Friday, April 29 at 11:45 a.m. ET
"Agreeing to Disagree: A Comparison of Antiplatelet and Anticoagulant Management Strategies at U.S. Versus International HVAD Implanting Centers" (poster presentation)
J. J. Teuteberg, K. D. Aaronson, C. Mahr, H. Reichenspurner, T. Krabatsch, C. B. Patel, M. Strueber, M. S. Kiernan, D. Zimpfer, M. V. Jacoski, S. Schueler
Friday, April 29 at 6:00 p.m. ET
Please note that this news release refers to third-party presentations of material related to the HVAD System and that the views expressed at ISHLT by any speaker or panelist who is not an employee of HeartWare or its subsidiaries do not necessarily reflect the views of HeartWare International, Inc.
About the HeartWare® Ventricular Assist System
The HVAD® System, is HeartWare's flagship product and features the world's smallest full-support circulatory assist device, the HVAD Pump, and is designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant other devices. The HeartWare System received CE Marking in the European Union in 2009 and was approved by the U.S. Food and Drug Administration in 2012 as a bridge to cardiac transplantation for patients who are at risk of death from refractory end-stage left ventricular heart failure. The device is also currently the subject of a U.S. clinical trial for destination therapy. Today, more than 10,000 patients with advanced heart failure in 47 countries around the world have received the HVAD System.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients around the world suffering from advanced heart failure. Dedicated to developing new, minimally invasive technologies to revolutionize the treatment of patients with end-stage heart failure, HeartWare has multiple technologies in development to offer progressively less-invasive mechanical circulatory support options. HeartWare's corporate headquarters are located in Framingham, Massachusetts, and the company has technology, operations, manufacturing and distribution centers in Miami Lakes, Florida; Arden Hills, Minnesota; and Hannover, Germany. For additional information about the company, please visit www.heartware.com.
HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are trademarks of HeartWare, Inc. or its affiliates.
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the: commercialization of the HeartWare HVAD System and timing, progress and outcomes of clinical trials; regulatory submissions and quality compliance; investigation, research and development activities; and our ability to take advantage of acquired and pipeline technology. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission (SEC). HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A. "Risk Factors" in HeartWare's Annual Report on Form 10-K filed with the SEC. HeartWare may update risk factors from time to time in Part II, Item 1A. "Risk Factors" in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the SEC.
For additional information:
HeartWare International, Inc.
Phone: +1 508 739 0864
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