Navigation Links
HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
Date:12/28/2010

FRAMINGHAM, Mass. and SYDNEY, Dec. 28, 2010 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

The PMA submission includes data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved IDE study designed to evaluate the HeartWare® Ventricular Assist 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.  The final implant in ADVANCE was performed in February 2010, and the last follow-up evaluation at 180-days was in August 2010.

Previously announced results for ADVANCE showed that 92% of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days.  Additionally, ADVANCE demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.

Results for the comparator arm of the study, derived from 499 contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) demonstrated 90% success of the primary endpoint at 180 days.  Based on these results for the primary endpoint of the ADVANCE study, noninferiority of the investigational device was established [p<0.0001].

About HeartWare InternationalHeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV p
'/>"/>

SOURCE HeartWare International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. HeartWare International, Inc. Announces Completion of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
2. HeartWare International, Inc. Announces Pricing of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
3. HeartWare International, Inc. Announces Concurrent Public Offerings of Convertible Senior Notes and Common Stock
4. HeartWare to Present at the Canaccord Genuity Cardio/Diabetes & Obesity Conference
5. HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial, ADVANCE
6. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
7. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
8. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
9. HeartWare to Report Financial Results for Third Quarter of 2010
10. HeartWare to Present at Lazard Capital Markets Circulatory Assist Device Day
11. HeartWare to Present at the UBS 2010 Global Life Sciences Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... , Sept. 3, 2015  VirtualScopics, Inc. (NASDAQ: ... trial imaging solutions, announced today, they are collaborating ... a new philanthropic, epidemiology study partnering with the ... .  VirtualScopics has teamed up with a cardiac ... The image results will be used to identify ...
(Date:9/3/2015)... 2015  Omeros Corporation (NASDAQ: OMER ) today ... Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, ... the District of New Jersey ... of Delaware . The lawsuits were ... three Omeros patents, U.S. Patent Nos. 8,173,707, 8,586,633 and ...
(Date:9/3/2015)... Sept. 3, 2015 Research and Markets ... the "Investigation Report on China Tamsulosin Market, ... Compared with other a1- adrenergic receptor blockers, ... and lower risk of urinary tract infections and ... its debut in 1993 in Japan ...
Breaking Medicine Technology:VirtualScopics, Inc. Collaborates with Large Pharmaceutical Company on a Philanthropic, Epidemiology Study in Africa 2VirtualScopics, Inc. Collaborates with Large Pharmaceutical Company on a Philanthropic, Epidemiology Study in Africa 3VirtualScopics, Inc. Collaborates with Large Pharmaceutical Company on a Philanthropic, Epidemiology Study in Africa 4Omeros Files Infringement Suits Against Par 2Omeros Files Infringement Suits Against Par 3Omeros Files Infringement Suits Against Par 4China Tamsulosin Market Investigation Report 2015 2
... 16, 2011 HYCOR Biomedical, Inc., a leading manufacturer and ... autoimmune and urinalysis markets, together with owner Linden, LLC, today ... Ph.D., to its Board of Directors as part of its ... welcome Drs. Aggarwal and Koziarz to the HYCOR team and ...
... May 16, 2011 Echo Therapeutics, ... tCGM System as a non-invasive, wireless, transdermal continuous ... System for transdermal drug delivery, today announced that ... its Chief Financial Officer.  Mr. Schnittker is a ...
Cached Medicine Technology:HYCOR Expands Board of Directors to Support Growth in Key Areas 2Echo Therapeutics Appoints Christopher P. Schnittker as Chief Financial Officer 2Echo Therapeutics Appoints Christopher P. Schnittker as Chief Financial Officer 3
(Date:9/3/2015)... ... ... Real Time Pain Relief (RTPR), makers of the popular rub-on pain ... an official endorsement deal with the company. Originally from New South Wales, Australia, Mason ... 15. He is an Australian bull riding champion, following in his uncles’ footsteps in ...
(Date:9/3/2015)... San Jose, CA (PRWEB) , ... September 03, ... ... high-performance Splashtop remote desktop solution for LANDESK Management Suite customers, as part of ... Management Suite’s user-centered approach to IT, by delivering the best mobile user experience ...
(Date:9/3/2015)... ... September 03, 2015 , ... The Linda Hall Library 2015 Fall ... comet, the IceCube observatory at the South Pole, and the interior of life-extending stem ... Series for the world's foremost independently funded research library devoted to science, engineering, and ...
(Date:9/3/2015)... ... ... According to an Oncology Nurse Advisor article published on August ... cancer (oral cancer) to be successfully diagnosed and treated for relapses of the disease. ... have a high rate of success in treatment and elimination of the disease; however, ...
(Date:9/3/2015)... ... ... Hunters Creek Retrievers is again honored to salute America's military ... Celebrate Fall 2015 with unlimited Free Hugs and K9 Kisses from a premiere sporting, ... with an extra big smile. , This adorable trained Lab Pup is now ...
Breaking Medicine News(10 mins):Health News:Real Time Pain Relief Sponsors the Talented PBR Bull Rider from Down Under - David Mason 2Health News:Real Time Pain Relief Sponsors the Talented PBR Bull Rider from Down Under - David Mason 3Health News:Splashtop Partners with LANDESK to Deliver High Performance Remote Access and Remote Support to and from Mobile Devices and Chromebook 2Health News:Splashtop Partners with LANDESK to Deliver High Performance Remote Access and Remote Support to and from Mobile Devices and Chromebook 3Health News:Splashtop Partners with LANDESK to Deliver High Performance Remote Access and Remote Support to and from Mobile Devices and Chromebook 4Health News:Facing the Frontiers of Science and Technology The Linda Hall Library Announces 2015 Fall Lecture Series Featuring Experiences from the South Pole to Outer Space 2Health News:Facing the Frontiers of Science and Technology The Linda Hall Library Announces 2015 Fall Lecture Series Featuring Experiences from the South Pole to Outer Space 3Health News:Facing the Frontiers of Science and Technology The Linda Hall Library Announces 2015 Fall Lecture Series Featuring Experiences from the South Pole to Outer Space 4Health News:Facing the Frontiers of Science and Technology The Linda Hall Library Announces 2015 Fall Lecture Series Featuring Experiences from the South Pole to Outer Space 5Health News:LA Periodontists Discuss Study on Post-Treatment Oral Rinses Used to Test Recurrence of Oral Cancers 2Health News:LA Periodontists Discuss Study on Post-Treatment Oral Rinses Used to Test Recurrence of Oral Cancers 3Health News:Hunters Creek Retrievers Is Honored to Support the Lone Survivor Foundation with a Championship Trained Black Labrador Retriever Puppy 2Health News:Hunters Creek Retrievers Is Honored to Support the Lone Survivor Foundation with a Championship Trained Black Labrador Retriever Puppy 3
... GREENSBORO, N.C., Oct. 29 Is there a ... the sponsorship of Lorillard Tobacco Company.,Families throughout the country ... a,real doctor when it comes to communicating an anti-smoking ... Michael Popkin, psychologist and,founder of Active Parenting Publishers and ...
... delivered following major funding award. , A vaccine developed ... fatal form of brain disease will be delivered to ... thanks to multi-million dollar funding. , The parasite ... 50,000 deaths from brain disease in the developing world ...
... has created sterling silver and 14k gold pendants intended to ... reframe the perception of ... million women,struggle with infertility. Life Medals, LLC has introduced the ... fine sterling silver and solid 14k gold pendants feature a,heart ...
... Derma Sciences, Inc.,(OTC Bulletin Board: DSCI), a company ... at the upcoming Rodman & Renshaw Annual,Global Investment Conference ... York City. The Company is scheduled to present on ... on the 4th floor., Management will discuss the ...
... and Japan-based Sato Sports Plaza to investigate new ... an effort to expand,global health and fitness research ... has formed an international science and health,exchange to ... research program with Sato Sports Plaza of,Japan is ...
... romantic love, study finds , , WEDNESDAY, Oct. 29 (HealthDay ... circuit" in the brain. , This hate circuit shares ... distinct from areas related to emotions such as fear, ... John Romaya, of University College London,s laboratory of neurobiology. ...
Cached Medicine News:Health News:Anti-Smoking Web Site Helps Parents Plug Into Prevention 2Health News:Fight begins to eradicate fatal parasite; first vaccines delivered following major funding award 2Health News:Fight begins to eradicate fatal parasite; first vaccines delivered following major funding award 3Health News:Infertility Survivor Creates Symbolic Pendant to Honor the Journey. 2Health News:Derma Sciences to Present at The Rodman & Renshaw 10th Annual Healthcare Conference 2Health News:New Program Internationalizes Health and Fitness Research 2Health News:Scientists Identify Brain's 'Hate Circuit' 2
The NIAGARA Thermal Retention System (TRS) maintains the temperature of prewarmed irrigation fluid continuously as it is delivered through the Corson®, Surgiflex® WAVE™, or Surgiflex D...
Simple, Effective Laparoscopic Irrigation Pumps from the Market Leader...
Stryker Endoscopy has combined a standardized pressurizing system with an advanced hand piece design that is lightweight and compact in order to streamline laparoscopic procedures....
... best of both worlds, the PeaceKeeper ... the latest addition to the Wet-Field ... cautery instruments for ophthalmic surgery. Combining ... aspiration and backflush functionality in a ...
Medicine Products: