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:9/29/2014)...  On Oct. 2, some 24,000 Lilly employees spanning ... Global Day of Service. Building on Lilly,s strong heritage ... a single, coordinated effort to improve the communities where ... so proud of this tradition, and of our Lilly ... the communities around the world where we live and ...
(Date:9/29/2014)... 2014 Kush Bottles, North America,s ... and consulting services for the medical and recreational marijuana ... has assumed the role of Chief Executive Officer. ... and worked as COO until February of 2014, returned ... other ventures. His return marks a clear dedication to ...
(Date:9/29/2014)... , Sept. 29, 2014  ADM Tronics ... it has entered into an affiliation with Triotech ... Cambridge, Massachusetts founded by ... member of ADMT,s Advisory Board. The ... technology companies with specialized services and finances to ...
Breaking Medicine Technology:Lilly's seventh Global Day of Service rallies 24,000 employees in nearly 60 countries 2Lilly's seventh Global Day of Service rallies 24,000 employees in nearly 60 countries 3Kush Bottles Co-Founder Steps into Role of CEO 2ADM Tronics Joins Triotech Ventures Technology Consortium 2ADM Tronics Joins Triotech Ventures Technology Consortium 3
(Date:9/30/2014)... If you were to create a list of ... say? Would you place a high value on charisma? Organizational ... a leadership “wish list,” the truth is that just as ... different types of leaders. But if good leaders come in ... that account for this kind of diversity? , PeopleKeys, ...
(Date:9/30/2014)... In a move that will deliver ... and management functions for sponsors, Synergy Research Group ... system. ClinCapture offers advanced out-of-the-box features that will ... trial data and avoid errors and duplications. This ... leading clinical research organization in the Russian region. ...
(Date:9/30/2014)... 2014 Miraca Life Sciences (MLS), the ... research posters at the annual meeting of the American ... its Annual Scientific Meeting and Postgraduate Course in Philadelphia, ... from Miraca Life Sciences will be at booth 711 ... Challenge. , The research posters for ACG provide a ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 Pyramid ... announced today that the Department of Veterans Affairs ... as its Enterprise End User Business Intelligence platform. ... support our nation’s veterans by enabling more than ... BI Office’s powerful enterprise analytics and reporting capabilities. ...
(Date:9/30/2014)... Signet Puerto Rico, a leading ... Juan, Puerto Rico, leverages RamSoft’s PowerServer RIS/PACS/PM™ to ... Souffront, site Administrator for Signet Puerto Rico, explains ... to bring in PowerServer RIS/PACS/PM because we will ... physician satisfaction while reducing our costs of delivering ...
Breaking Medicine News(10 mins):Health News:Personality Plays a Key Role in Leadership Development 2Health News:Personality Plays a Key Role in Leadership Development 3Health News:Synergy Research Group Opts for Clinovo 2Health News:Synergy Research Group Opts for Clinovo 3Health News:Miraca Life Sciences Research Institute to Present Eight GI Pathology Research Studies at Annual Meeting of American College of Gastroenterologists 2Health News:U.S. Department of Veterans Affairs Takes Its Analytic Capabilities to the Next Level with BI Office from Pyramid Analytics 2Health News:Signet Puerto Rico Leverages PowerServer RIS/PACS/PM™ to Improve Patient Care, Cut Costs 2
... , NEWARK, N.J., Aug. 6 /PRNewswire-USNewswire / -- ... New Jersey throughout the week of August 9-15 at various cities ... information on programs that provide prescription medicines for free or nearly ... compared to 5.1% a year ago -- the Partnership for Prescription ...
... , NEW YORK, Aug. 6 Care to ... announced today that is has been awarded Full Accreditation in ... nonprofit health care accrediting organization. , , ... of health care management through processes of accreditation and education. ...
... , UNITED NATIONS, Aug. 6 ... Population Fund, are critical to enhancing efforts to reduce maternal ... Representatives of more than 40 international faith-based organizations emphasized ... a policy round table on a range of issues including ...
... Monographs addressing individual mandates, tax exclusion and a public ... of Physicians (ACP). The new policy papers are: ... , Reforming the Tax Exclusion for Health Insurance, A ... "These monographs provide an evidence-based analysis of ...
... , , NEW YORK, Aug. ... now confirmed that America is in a national obesity crisis. More ... America,s well-being, not only as individuals, but as a country. , ... powerful nation when we join together and take a stand. More ...
... , SOUTH PASADENA, Calif., Aug. 6 ... free-standing multi-specialty cancer center in South Pasadena. The 22,000 s.f. ... provide outpatient services in medical, surgical and radiation ... kind in the San Gabriel Valley to offer RapidArc((TM)), a ...
Cached Medicine News:Health News:Partnership for Prescription Assistance Prepared to Help New Jersey Workers Hurt by Recession 2Health News:Partnership for Prescription Assistance Prepared to Help New Jersey Workers Hurt by Recession 3Health News:Partnership for Prescription Assistance Prepared to Help New Jersey Workers Hurt by Recession 4Health News:Care to Care Receives Full URAC Health Utilization Management Accreditation 2Health News:Care to Care Receives Full URAC Health Utilization Management Accreditation 3Health News:Cooperation Between Faith-Based Organizations and UNFPA Critical to Maternal Health, Say Groups 2Health News:Internists tackle key health reform issues 2Health News:Internists tackle key health reform issues 3Health News:America Takes on the Challenge to Fight Obesity 2Health News:America Takes on the Challenge to Fight Obesity 3Health News:America Takes on the Challenge to Fight Obesity 4Health News:California Cancer Specialists Medical Group, Inc. Opens Outpatient Cancer Center in South Pasadena, Calif., With Renowned Medical Staff, State-of-the-Art Technology 2
... lenses and frames are designed with the safety ... lenses are Schott RS-520 (also called SF-6) leaded ... These lenses meet standards, as set for optical ... ,While our eyewear is protecting your eyes, ...
... Protection Goggles fit over ... used by the whole ... glass, 1.0 mm leaded ... increased scatter radiation protection. ...
... Jarrod Goggles have set the standard ... soft silicone saddle nose bridge. Monel ... and lasts longer. Adjustable elastic headband ... breakable plastic strap clips. 0.75 mm ...
QualCraft™ Euro Lite has a molded nylon frame that fits most faces. Universal keyhole nose bridge fits narrow to average noses. Available with or without lead vinyl-lined side shields....
Medicine Products: