Navigation Links
HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
Date:4/25/2012

FRAMINGHAM, Mass. and SYDNEY, April 25, 2012 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) today announced that NASDAQ has halted trading of the Company's common stock.  The U.S. Food and Drug Administration's (FDA) Circulatory System Devices Advisory Committee meets today to review HeartWare's Premarket Approval (PMA) application for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

HeartWare's PMA submission encompasses data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption study designed to evaluate the HVAD System as a bridge to heart transplantation for patients with end-stage heart failure.  Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010.  HeartWare submitted the PMA in December 2010. 

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD® pump, a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  The HeartWare System has received CE Marking in the European Union and TGA approval in Australia.  The device is currently the subject of United States clinical trials for two indications: destination therapy and bridge-to-transplant under a continued access protocol.  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 and the Australian Securities Exchange.

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 timing and progress of, and presentation of data related to, clinical trials, expected timing of regulatory filings and approvals, 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.  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, the possibility the FDA does not approve the marketing of the HeartWare® Ventricular Assist System in the U.S., and those described in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission.  We may update our risk factors from time to time in Part II, Item 1A "Risk Factors" in our 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@heartwareinc.com
Phone: +1 508 739 0864

 

 


'/>"/>
SOURCE HeartWare International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Presentation of HeartWare Clinical Results
2. HeartWare International Clinical Trial Shows 90% Survival at 180 Days
3. U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
4. HeartWare International Reports Third Quarter Revenues of $7.5 Million
5. HeartWare to Present at 21st Annual Piper Jaffray Health Care Conference in New York City
6. HeartWare to Present at the UBS 2010 Global Life Sciences Conference
7. HeartWare to Present at Lazard Capital Markets Circulatory Assist Device Day
8. HeartWare to Report Financial Results for Third Quarter of 2010
9. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
10. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
11. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... MOUNTAIN VIEW, Calif. , Feb. 10, ... result of a synergistic confluence of various ... unique value propositions, previously unavailable. These opportunities ... convergence and convergence, in turn, drives the ... Today,s entrepreneurial scenario is characterized by technology ...
(Date:2/10/2016)... Jersey and OR AKIVA, Israel ... Regentis Biomaterials Ltd., a leader in the ... Series D investment round on February 5, 2016. The ... Group ("Haisco"), a leading Chinese pharmaceutical manufacturer, and ... SCP Vitalife Partners, Generali Financial Holdings and both the ...
(Date:2/10/2016)... ALSP, Inc. announced that it has appointed Col.(Retired) Dallas ... preparation for its move into clinical trials with its lead ... are pleased to welcome Dallas Hack onto the ... of such practical knowledge and far-reaching experience in Traumatic Brain ... broad experience and success as a clinician and researcher in ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... InDemand Interpreting , ... recently partnered with Heart City Health Center to improve access to ... Heart City Health Center has provided the Elkhart community with access to high ...
(Date:2/10/2016)... ... February 10, 2016 , ... Emergency rooms provide emergency care to stabilize critical ... leave patients with dental emergencies at risk of losing a tooth or their smiles. ... , Common dental emergencies include:, , Avulsed or knocked-out ...
(Date:2/10/2016)... , ... February 10, 2016 , ... Ongoing news of ... Life Care Association™ (ALCA) to conduct a survey that takes a closer look at ... today illustrates the prevalence and causes of TBI among the aging population, and identifies ...
(Date:2/10/2016)... , ... February 10, 2016 , ... AxoGen, Inc. (NASDAQ: ... report results for the fourth quarter and full year ended December 31, 2015 on ... conference call and webcast for the investment community following the release at 4:30 PM ...
(Date:2/10/2016)... ... 2016 , ... For additional information contact Phyllis Strupp 480-488-5858 , Brain improves ... The Ultimate Guide to Brain Training" by award-winning author Phyllis Strupp explains ... is March 16, 2016. A free review copy is available to the media ...
Breaking Medicine News(10 mins):