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

FRAMINGHAM, Mass., and SYDNEY, June 17, 2013 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval to an IDE (Investigational Device Exemption) Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the Company's pivotal, Destination Therapy clinical study.

ENDURANCE is a randomized, controlled, unblinded, multi-center clinical trial to evaluate the use of the HeartWare® Ventricular Assist System as a Destination Therapy in advanced heart failure patients.  The non-inferiority study completed enrollment of 450 patients with end-stage heart failure who had not responded to standard medical management and who were ineligible for cardiac transplantation.  Patients were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative LVAD approved by the FDA for Destination Therapy, in a 2:1 ratio.

The primary endpoint of the trial is stroke-free (Modified Rankin Score > 4) survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.  The final implant was conducted in May 2012, which will result in the final patient reaching the two-year follow up point in May 2014.

Supplemental Patient Cohort

FDA granted conditional approval to a protocol desi
'/>"/>

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:7/11/2014)... Neurelis, Inc. ("Neurelis") today announced an agreement ... held by Biotie to purchase Neurelis, clearing the way ... diazepam) for pediatric and adult epilepsy patients who experience ... Biotie has advanced the development program for NRL-1 and ... work required for NDA submission to the FDA.  Given ...
(Date:7/10/2014)... July 10, 2014  Breg, Inc., a premier ... launched the FreeRunner™ knee brace with new innovations ... patella mal-tracking return to active lifestyles.  FreeRunner,s patent-pending ... braces, providing support when patients need it most, ... don,t. Patellofemoral issues are the most ...
(Date:7/10/2014)... , July 10, 2014  BC Technical, the ... MiE America , Inc., a leading provider of ... into a long-term agreement naming BC Technical as the ... MiE and BC Technical announced today ... to establish BC Technical as the service and systems ...
Breaking Medicine Technology:Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2
... 20, 2011 Ann Arbor SPARK recently celebrated the conclusion ... and a reception.  At the Ann Arbor SPARK Boot Camp ... Boot Camp" winner, based on the quality of its investor ... engagement though the Ann Arbor SPARK Business Accelerator.   ...
... HYDERABAD, India, May 20, 2011 Neuland Laboratories Ltd., ... (APIs), complex intermediates, and contract research and manufacturing services ... results for the 2011 fiscal year (FY) ended March ... report that in fiscal year 2011, Neuland delivered on ...
Cached Medicine Technology:Brio Device Awarded Best of Ann Arbor SPARK's Boot Camp 2Neuland Labs Reports Financial Results for Fiscal Year 2011 2
(Date:7/13/2014)... Epidemiologists forecast an increase in the diagnosed incident ... incident cases in 2013 to 11,568 diagnosed incident cases ... 4.35%, during the forecast period. In 2023, the US ... of aGVHD in the 6MM, with 4,989 diagnosed incident ... diagnosed incident cases of aGVHD, with 704 diagnosed incident ...
(Date:7/13/2014)... decreased ability to identify odors might indicate the ... examinations of the eye could indicate the build-up ... the brain, according to the results of four ... International Conference 2014 (AAIC 2014) in Copenhagen. , ... to identify odors was significantly associated with loss ...
(Date:7/13/2014)... Wright & Schulte LLC has learned ... in July of 2015, in U.S. District Court, District ... the discovery process in the South Carolina federal ... over the multidistrict litigation (MDL). The complaints pending in ... who allege that they took the statin medication to ...
(Date:7/13/2014)... Hills, California (PRWEB) July 13, 2014 ... Danny Musico has formed a promotional partnership with Aqua ... plant based Omega-3 EPA supplement . The collaboration ... is a celebrity fitness trainer , actor, model, ... Hollywood’s go-to trainer for A-List celebrities, he has prepared ...
(Date:7/13/2014)... July 13, 2014 Hope Palliative & Hospice ... grief support group at the Tamarack Senior Living Community in ... at 10:30 A.M. on the 3rd Wednesdays of every month. ... at the Tamarack Community located at 55 S. Greeley St. ... individuals and there is no cost for the group. ...
Breaking Medicine News(10 mins):Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 2Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 3Health News:Graft-Versus-Host Disease Market (GVHD) Growing at 4.35% AGR to 2023 Says a New Report Available at ReportsnReports.com 4Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 2Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 3Health News:Lipitor Lawsuits Move Forward With Scheduling Of First Bellwether Trial 4Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2Health News:Hope Hospice Announces Grief Support Group at the Tamarack Senior Living Community 2
... undertake a long-term weight training program produce more ... physiologists //to understand why weight training improves muscle ... study published in the December issue of the ... different forms of growth hormone, used different testing ...
... found that young women who grow up in cities or move ... ,Princess Diana was known to suffer from this eating ... country, and moved to London as a teenager. ,Bulimia ... a routine of over-eating and vomiting or purging. This study ...
... researchers have discovered a protein interaction that may explain ... findings, published in and featured on the cover of ... the mutated Huntington’s protein interacts with another protein to ... , ,“Cholesterol is essential for promoting the connection ...
... issue of Human Gene Therapy has published the findings ... to treat erectile dysfunction.// The finding shows that gene ... gene therapy is beneficial for months, and hence could ... ,Lead author Arnold Melman, M.D., professor and ...
... told that patients undergoing chemotherapy in remote areas may be ... patient sending a text of his symptoms according to their ... of a red alert sent to medical staff, or an ... new age technology may be used along with a mobile ...
... is always the case that women would have to work ... be it in career or otherwise. This was recently reiterated ... of Physiology-Endocrinology and Metabolism”. ,According to this ... of growth hormone by women whereas men use testosterone for ...
Cached Medicine News:Health News:Varying Weight Training Intensity Ups Growth Hormone in Women 2Health News:Link Between Huntington’s and Abnormal Cholesterol Levels in Brain Establishe 2Health News:Gene Therapy May Be the Solution for Erectile Dysfunction 2
The Pach IV is the premier product for cornea thickness measurement in conjunction with Glaucoma screening....
Inquire...
... Immunosorbent Assays(ELISA) is intended for the detection ... Measles Rubeola) virus in human sera. Individual ... determination of immune status. Paired sera, acute ... or a significant rise in antibody as ...
Measles IgM ELISA test is an enzyme linked immunosorbent assay (ELISA) for the detection of IgG class antibodies to Measles (Rubeola) in human serum or plasma....
Medicine Products: