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:7/31/2015)...  Xcelience, a contract development and manufacturing organization ... structured cash investment in Powdersize, a ... and powder size classification within the pharmaceutical industry.  ... simultaneously adding a complete set of particle size ... "As we continue to build our ...
(Date:7/31/2015)... and SAN DIEGO , ... its parent company Eisai Co., Ltd. (Headquarters: ... , "Eisai") and Halozyme Therapeutics, Inc. (Headquarters: ... Helen Torley , "NASDAQ: HALO") have signed a ... name: Halaven ® , "eribulin") in combination with Halozyme,s ...
(Date:7/30/2015)... 2015 Edwards Lifesciences Corporation (NYSE: EW ), ... hemodynamic monitoring, today announced that Robert A. Ingram ... "Bob is an ardent champion for innovation in the lifesciences ... him on Edwards, board as we pursue our focused innovation ... CEO.  "Bob has provided a valuable perspective to our board, ...
Breaking Medicine Technology:Xcelience Makes Structured Cash Investment in Powdersize 2Xcelience Makes Structured Cash Investment in Powdersize 3Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 2Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 3Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 4Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 5Eisai and Halozyme Sign Collaboration Agreement to Investigate Eribulin and PEGPH20 in Metastatic Breast Cancer 6
(Date:7/31/2015)... , ... July 31, 2015 , ... Ticket Down is a reputable source of authentic ... MGM Grand Garden Arena. Fans of every genre of music will have an act ... the first day of the festival, the following artists will perform: Sam Smith, Coldplay, ...
(Date:7/31/2015)... ... , ... Super Bowl 50 will emanate from Levi’s Stadium in Santa Clara, CA ... the Super Bowl. In the two weeks that separate the conference championships and the Super ... Super Bowl game will mark the 50th time it has been held and the festivities ...
(Date:7/31/2015)... ... 31, 2015 , ... Recently touted by Becker’s Healthcare as ... analytics , Jvion continues to disrupt the predictive analytic and big data market ... and population level illness to drive prevention and better health outcomes. Most recently, ...
(Date:7/31/2015)... ... ... Sculpted Contours Luxury Medical Aesthetics announces the arrival of the newest applicator ... new applicator in the United States as an upgrade to the CoolSmooth applicator cleared ... applicator required a 2 hour treatment time. The new CoolSmooth Pro reduces the ...
(Date:7/31/2015)... ... July 31, 2015 , ... Facebook, Twitter, ... has re-branded their social media profiles to better connect with the public. The ... communicate, find information, share insights and opinions. The Rally Insurance Group, Inc.’s pledge ...
Breaking Medicine News(10 mins):Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Cheap 2016 Super Bowl Tickets at Levi's Stadium: Ticket Down Slashes Ticket Prices on Super Bowl 50 Tickets in Santa Clara, CA at Levi's Stadium 2Health News:Jvion Showcased as Leader in the Predictive Analytic Market 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 2Health News:Cooler Coolsculpting in Atlanta: Treatments Now Twice As Fast 3Health News:Rally Insurance Group, Inc. Connects to Customers Through Re-branded Social Media Profiles 2
... bird, Paris Hilton, is reportedly having a tough time with ... video, One Night In Paris , with ex- beau Rick ... at the Lynwood centre by saying 'Paris sure knows how ... ,A jail inmate, Danita Daniel, said that prisoners were constantly ...
... about racial inequalities, even at the cost of lives, are ... finds that blacks are far less likely than whites ... heart attack, which leave them more vulnerable to future fatal ... Journal of the American Medical Association, tracked 1.2 million Medicare ...
... the prosthesis that has helped thousands of disabled worldwide to ... first centre on foreign soil . ,The Colombian government ... of the artificial limb, to set up base in the ... with a Colombia-based NGO. ,M.K. Mathur of BMVSS ...
... new study, skin cancer levels have shown a significant increase ... is more likely to affect those living in more affluent ... people are more prone to the disease. ,Researchers, ... over a 12-year period, reported a 20 per cent increase ...
... informed by my physician that what I "thought" to be a ... me without antibiotics I could wind up in the hospital . ... can afford to "die" because I have life insurance, only I ... "abuse" is. It is the over inflated prices of medical care ...
... new study has emphasised the safety and efficacy of ... (RA) patients . ,Biologics, such as etanercept, ... protein in the body called tumour necrosis factor that ... etanercept, also known as an anti-TNF therapy, etanercept has ...
Cached Medicine News:Health News:Racial Discrimination Takes The Nobility Out Of Doctoring 2Health News:Jaipur Foot All Set to Launch Its Centre in Columbia 2Health News:Deadly Skin Cancer Bites the Rich Harder 2Health News:Deadly Skin Cancer Bites the Rich Harder 3Health News:Ask Right Questions and Save Country from Further Healthcare Crisis: Michael Moore 2Health News:Study Reinforces Safety of Long-term Biologic Treatment for Rheumatoid Arthritis 2
... is the wall organizer with a complete set ... sizes and diameters. Made of tough, durable plastic ... Nest is the ultimate organizer. , The ISI ... a variety of lengths, diameters and composition.,The long, ...
... Instra-Glide Target is the non-silicone lubricant ... , ,Instra-Glide Target lubricates sticky pivot points, ... The penetration straw allows you to lubricate ... and painted surfaces. Ideal for carts, hinges, ...
... "CSK" stands for Cool Soak ... deposits without an ultrasonic cleaner. , ,Don't ... to clean instruments not normally cleaned in ... soaking solution removes rust, stains and mineral ...
Shandon Excelsior ES Tissue Processor continues the Thermo Electron Corporation tradition of offering one of the most advanced, traditional reagent instruments available today....
Medicine Products: