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HeartWare International Receives Health Canada Approval For Commercialization Of The HeartWare® Ventricular Assist System As A Bridge To Heart Transplantation
- First, full-support, miniaturized ventricular assist device designed to be placed in the pericardial space to receive approval in Canada -

FRAMINGHAM, Mass., April 9, 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 that it has received approval from Health Canada, the country's federal department responsible for helping Canadians maintain their health, to market the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.

The HeartWare(R) Ventricular Assist System featuring the HVAD(R) Pump has received approval from Health Canada for commercialization as a bridge to heart transplantation in patients with end-stage heart failure.  More than 8,000 advanced heart failure patients around the world have received this small, full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

"We gained valuable experience with the HeartWare® System under Health Canada's Special Access program and found it to be an important addition to our treatment options, particularly with difficult-to-treat patients," said Vivek Rao, M.D., Ph.D., M.S., FRCSC, Chief of Cardiovascular Surgery and Director of Mechanical Circulatory Support at the Peter Munk Cardiac Centre, University Health Network in Toronto.  "With Health Canada approval, we look forward to continuing our positive experience with this device."

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.

"Approximately the size of a golf ball, the small HVAD Pump allows for ease of implantation and pursuit of less invasive surgical approaches," said Anson Cheung, M.D., B.S., M.S., FRCSC, Director of Cardiac Transplant at St. Paul's Hospital in Vancouver, and Professor of Surgery at the University of British Columbia.  "Since 2010, we've been able to build an extensive and positive clinical experience with the HVAD Pump.  Earlier this year, we commenced LATERAL, a clinical trial to examine the potential benefits of implanting this device through a less invasive left thoracotomy technique, as an alternative to the sternotomy approach associated with many cardiac surgeries."

"We are grateful for the efforts of the leading heart failure specialists in Canada who have worked diligently to gain an understanding of the attributes of the HeartWare System and share insights as we worked toward commercial approval," said Doug Godshall, President and CEO at HeartWare.  "We look forward to demonstrating the benefits of the HeartWare System in a larger patient population in Canada, as we gain commercial experience with this device in an important new geography."

The HeartWare Ventricular Assist System received U.S. Food and Drug Administration (FDA) approval in 2012 as a bridge to heart transplantation in patients with end-stage heart failure.  The HeartWare System has been the leading ventricular assist device implanted in patients outside of the United States for the last three years, having received CE Marking in the European Union in 2009 and Australian Therapeutic Goods Administration (TGA) approval in 2011.  Today, more than 8,000 advanced heart failure patients globally have received the HVAD Pump.

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 41 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 the HeartWare System and 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 additional information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com  
Phone: +1 508 739 0864

Photo - http://photos.prnewswire.com/prnh/20150409/197547

 

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SOURCE HeartWare International, Inc.

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