Navigation Links
HeartWare Receives Conditional Approval From FDA to Enroll Supplemental Patient Cohort in Destination Therapy Trial
Date:6/17/2013

gned to confirm observations from ENDURANCE that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events.  

In this supplemental cohort, HeartWare will enroll up to an additional 240 HeartWare HVAD patients, as well as up to an additional 120 control patients using a randomization scheme consistent with the ENDURANCE protocol.  Patients will be followed for 12 months after implant.  HeartWare intends to incorporate the data from this new cohort into an anticipated Pre-Market Approval (PMA) Application seeking approval of the HeartWare System for the Destination Therapy indication.  

Patient enrollment in this supplemental cohort can commence at the 50 centers participating in the ENDURANCE clinical trial, following edits to the protocol as prescribed by FDA and Institutional Review Board approvals at each of the centers.

On November 20, 2012, FDA granted approval of the HeartWare System for the Bridge-to-Transplant indication.  Concurrent with approval, the Company commenced a post-approval study (PAS) to assess device performance in a real-world setting.  HeartWare's PAS is a registry consisting of 600 patients who receive an HVAD and an additional 600 control patients derived from a contemporaneous group of continuous flow, intra-corporeal LVAD patients entered into the INTERMACS database.  HeartWare expects enrollment for both arms of the PAS will be complete by year's end. 

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-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally requir
'/>"/>

SOURCE HeartWare International, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. HeartWare Presentation at the Wells Fargo Securities 2013 Healthcare Conference to be Webcast
2. HeartWare International Announces Intention To Delist From Australian Securities Exchange (ASX)
3. HeartWare Presentation At The Goldman Sachs 34th Annual Global Healthcare Conference To Be Webcast
4. HeartWare Presentation At The 2013 UBS Global Healthcare Conference To Be Webcast
5. HeartWare Presentation at the Bank of America Merrill Lynch 2013 Health Care Conference to be Webcast
6. HeartWare International Reports $49.2 Million In First Quarter 2013 Revenue; 87% Increase From First Quarter Of 2012
7. HeartWare Schedules First Quarter Conference Call And Webcast
8. HeartWare International, Inc. Announces Pricing of Public Offering of Common Stock
9. HeartWare International, Inc. Announces Public Offering of Common Stock
10. HeartWare Presentation at the Barclays Capital 2013 Global Healthcare Conference To Be Webcast
11. HeartWare Presentation At Raymond James 34th Annual Institutional Investors Conference To Be Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/15/2014)... /PRNewswire-iReach/ -- Asthma is a chronic inflammatory lung ... most commonly starts in childhood. It is a ... airways, leading to airflow limitation and airway hyper-responsiveness ... endogenous and exogenous irritants. Exposure to irritants instigates ... the airways, tightening of the respiratory muscles, and ...
(Date:9/15/2014)... , Sept. 15, 2014 /PRNewswire-iReach/ -- MedicOne Medical Response, ... services, has been selected by Inc. Magazine as ... America. Photo - http://photos.prnewswire.com/prnh/20140914/145997 ... list identifies successful, privately-held companies with the largest ... Response, one of only two ambulance companies to ...
(Date:9/15/2014)... Nev. , Sept. 15, 2014 PDL BioPharma, ... that it has paid the September 12, 2014, regular quarterly ... owning shares of PDL as of September 5, 2014, the ... PDL BioPharma manages a portfolio of patents and ... antibody humanization patents and license agreements with various biotechnology ...
Breaking Medicine Technology:Asthma Market to Reach 161.02 million Cases in 10MM by 2023 2Asthma Market to Reach 161.02 million Cases in 10MM by 2023 3Asthma Market to Reach 161.02 million Cases in 10MM by 2023 4Asthma Market to Reach 161.02 million Cases in 10MM by 2023 5MedicOne Medical Response Named to 2014 Inc. 5000 Fastest Growing Companies List 2MedicOne Medical Response Named to 2014 Inc. 5000 Fastest Growing Companies List 3PDL BioPharma Completes Regular Quarterly Dividend Payment 2
... to Prevent,and Reverse Atherosclerotic Heart Disease, EMERYVILLE, Calif., ... drug discovery and development company, announced,today the first ... in animals through the pathway known as reverse ... by which excess,cholesterol can be removed from tissues ...
... 14, 2007 - Acceleron Pharma,Inc., a biopharmaceutical ... metabolic and cancer-related,diseases, today announced results of ... ability of the compound to increase,muscle mass ... murine models of,muscular dystrophy. ACE-031 inhibits negative ...
Cached Medicine Technology:KineMed Presents Data Measuring Changes in Reverse Cholesterol,Transport for the First Time 2KineMed Presents Data Measuring Changes in Reverse Cholesterol,Transport for the First Time 3Acceleron Pharma's ACE-031 Increases Muscle Mass and Strength in,Preclinical Studies 2Acceleron Pharma's ACE-031 Increases Muscle Mass and Strength in,Preclinical Studies 3
(Date:9/15/2014)... 2014 Crosley Law Firm is proud to ... have been named to the list of Super Lawyers in ... of personal injury law. , Before receiving the designation ... selection process. First, they must come highly recommended by a ... noteworthy achievement during the past year by obtaining certain honors, ...
(Date:9/15/2014)... September 16, 2014 “Advanced First Aid for ... author Frank O’ Connor leads readers from occupational first aid ... first aid without any difficulty. There are over 165 photographs ... skill sets. , This book is an ideal reference ... course manual. It is in essence three books in one. ...
(Date:9/15/2014)... the University of Copenhagen have gained new knowledge ... The findings have recently been published in the ... The defining symptoms of Parkinson,s disease are slow ... no cure for the condition, so it is ... to shed some light on this terrible disruption ...
(Date:9/15/2014)... 2014)The Global Health Innovative Technology Fund (GHIT Fund), ... Japanese know-how and investment to the global fight ... totaling US$15.3 million to speed the development of ... diseasesmalaria, dengue and Chagas disease. The announcement marks ... since November 2013totaling $33.5 millionaimed at diseases that ...
(Date:9/15/2014)... (PRWEB) September 15, 2014 College of Osteopathic ... recently sat in the lobby of Western University of Health ... Gomez. He asked Gomez about his medications, his blood pressure ... “He’s helping me a lot. He’s a good man,” Gomez ... student doctor and patient are part of the Longitudinal Chronic ...
Breaking Medicine News(10 mins):Health News:Thomas A. Crosley and R. Andrew Rodriguez Named 2014 Super Lawyers 2Health News:Frank O'Connor's new book explains importance of occupational and advanced first aid 2Health News:Researchers debunk myth about Parkinson's disease 2Health News:Japanese Global Health Fund awards $33.5 million to develop vaccines, drugs for neglected diseases 2Health News:Japanese Global Health Fund awards $33.5 million to develop vaccines, drugs for neglected diseases 3Health News:Japanese Global Health Fund awards $33.5 million to develop vaccines, drugs for neglected diseases 4Health News:Japanese Global Health Fund awards $33.5 million to develop vaccines, drugs for neglected diseases 5Health News:COMP Takes the Long View of Health Care 2Health News:COMP Takes the Long View of Health Care 3Health News:COMP Takes the Long View of Health Care 4
... collaboration between researchers at the Salk Institute for Biological ... the tumor suppressor p53, long thought of as the ... cancer-causing mutations. It may also prevent established cancer cells ... serving as a "Guardian against Genome Reprogramming." The ...
... St. Louis and a woman in New Hampshire have received ... program of the Organ Procurement and Transplantation Network (OPTN) that ... candidates with living donors. Both recipients Ken Crowder of ... loved ones who were willing to donate a kidney but ...
... discrimination among Mexican and Mexican American students from Phoenix-area ... stress when trying to acculturate with mainstream U.S. culture, ... experienced acculturation stress related to discrimination, they were at ... The study is in the December issue of ...
... , MONDAY, Dec. 13 (HealthDay News) -- A federal judge ... unconstitutional, saying the federal government has no authority to require ... a cornerstone of the new legislation, signed into law in ... not unexpected, and both supporters and opponents of the legislation ...
... million men and women ages 50 to 64 stand ... that expand access to affordable health insurance, assure that ... insurers from denying coverage or charging higher premiums to ... limits in health insurance policies, according to a new ...
... the activity of genes direct changes to the DNA ... genes are switched on and off, called epigenetic means. Tumor-suppressor ... for the cancerous growth of cells. Researchers at the ... on a genome-wide scale in cases of ovarian cancer. ...
Cached Medicine News:Health News:The stemness of cancer cells 2Health News:The stemness of cancer cells 3Health News:2 people receive kidney transplants in pilot program using CMU software 2Health News:2 people receive kidney transplants in pilot program using CMU software 3Health News:Drug use and discrimination among Phoenix area Mexican heritage youth 2Health News:Drug use and discrimination among Phoenix area Mexican heritage youth 3Health News:Federal Judge Strikes Down Health Reform Law 2Health News:Federal Judge Strikes Down Health Reform Law 3Health News:18.3 million baby boomers could benefit from the Affordable Care Act 2Health News:18.3 million baby boomers could benefit from the Affordable Care Act 3Health News:18.3 million baby boomers could benefit from the Affordable Care Act 4Health News:Ovarian cancer advances when genes are silenced 2
... ,Smaller slot surface area results in ... ,Small slot dimensions require less sample than ... intense signal generated with the slot-blotter allows you ... Accepts all types of transfer membranes ...
... system consists of four basic components: sample well ... clamping plate (see diagram). The sample well plate ... dots, or slots (see below). All three plates ... accessory plate in conjunction with a complete system. ...
... (slot format) microfiltration units provide a reproducible ... in solution onto nitrocellulose or Zeta-Probe membrane. ... using interchangeable templates to form the 96-well ... SF apparatus. Each is available as a ...
... plastic tray. Ideal for staining westerns and ... for multipurposes. Pour spouts in each corner ... label may be used for identification. Lid ... or shakers for staining several gels simultaneously. ...
Medicine Products: