Press Release

HeartWare Begins HVAD® LATERAL Study, A Clinical Trial Of Advanced Heart Failure Patients Implanted Via Less-Invasive Thoracotomy Technique

FRAMINGHAM, Mass., Jan. 13, 2015 /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 the first patient implant in the HVAD® LATERAL Study, a U.S. Investigational Device Exemption (IDE) clinical trial in which the HeartWare® Ventricular Assist System, featuring the HVAD® Pump, is implanted through a less-invasive thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant.

The HVAD® LATERAL Study is designed to study the clinical outcomes of this surgical technique.  Currently, commercially available ventricular assist systems are only approved by the U.S. Food and Drug Administration for use with implantation via median sternotomy, a common surgical approach in cardiac surgery which utilizes a vertical incision through the center of the patient's chest.  With the less-invasive thoracotomy approach, the HVAD® Pump, which is smaller than other contemporary devices, is implanted using a small lateral thoracotomy incision between the patient's ribs on the left side of the chest.

"The thoracotomy implant technique holds considerable promise for making implantation easier for the surgeon and better tolerated by the patient," said Ed McGee, M.D., head of the heart transplant and assist device program and a professor in the Department of Thoracic and Cardiovascular Surgery at Loyola University Chicago Stritch School of Medicine, and a Co-Principal Investigator for the HVAD® LATERAL Study.  "Implantation via thoracotomy allows for preservation of a sternotomy for a heart transplant, making that subsequent surgery less difficult for the bridge-to-transplant patient."

The first clinical trial of a full-support ventricular assist device (VAD) to utilize an implant technique other than sternotomy, the HVAD LATERAL Study is a prospective, multi-center, single-arm clinical trial which will enroll up to 120 patients at 30 U.S. hospitals.  The study population will include patients with end-stage heart failure who have not responded to standard medical management and who are eligible for cardiac transplantation.  The primary survival endpoint will be measured at six months post-implant and compared to a performance goal.  Patient screening for implantation has begun at some sites, and may commence immediately at each trial center, following Institutional Review Board approval.

"Conducting this study will facilitate a robust discussion of innovative surgical techniques, and development of best practices to help achieve optimal patient outcomes," noted Anson Cheung, M.D., surgical director of cardiac transplantation of British Columbia and clinical professor of surgery at the University of British Columbia, Department of Surgery, Division of Cardiovascular Surgery and Co-Principal Investigator of the trial.

"We have observed a marked increase in thoracotomy interest in the U.S. and internationally, with more than 20 percent of global HVAD implants in the past year performed via this less-invasive method," said Doug Godshall, President and CEO at HeartWare.  "We are encouraged that physicians are able to take advantage of the versatility of the HVAD Pump and look forward to confirming the potential benefits of the thoracotomy implant technique previously published through single-center studies in the U.S. and Europe."

About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. The HeartWare System is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, has received CE Marking in the European Union and has been used to treat patients in 40 countries. The device is also currently the subject of a U.S. clinical trial for destination therapy. For additional information, please visit the Company's website at www.heartware.com.

HeartWare International, Inc. is a member of the Russell 2000® and its securities are publicly traded on The NASDAQ Stock Market.

HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare logos are registered trademarks of HeartWare, Inc.

Forward-Looking Statements
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® Ventricular Assist System, the potential benefits of less invasive implant techniques, clinical trials, regulatory status and research and development activities.  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 CommissionHeartWare 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 Securities and Exchange CommissionHeartWare 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 Securities and Exchange Commission.

For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com 
Phone: +1 508 739 0864

 

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SOURCE HeartWare International, Inc.

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