Navigation Links
HeartWare Receives Third Patient Allotment From FDA - Authorizing 94 Additional Patients - Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
Date:1/24/2011

FRAMINGHAM, Mass. and SYDNEY, Jan. 24, 2011 /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 approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).  The FDA granted two prior allotments of 54 patients each in April and September 2010, and the final patient from the second cohort was implanted earlier this month.

HeartWare's ADVANCE clinical trial is 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 the ADVANCE study, 140 patients at 30 U.S. clinical sites received HeartWare HVAD® pumps, making it the largest bridge-to-transplant pivotal trial to date.  HeartWare submitted to the FDA a Pre-Market Approval (PMA) application seeking approval of the HeartWare System for the bridge-to-transplant indication in December 2010.

Patient enrollment under the third CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at these sites.  

About HeartWare InternationalHeartWare 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-output circulatory support device (up to 10L/min flow) designed to be implante
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. HeartWare to Present at the 29th Annual J.P. Morgan Healthcare Conference
2. HeartWare Files PMA Application for FDA Approval of the HeartWare® Ventricular Assist System for a Bridge-to-Transplant Indication
3. HeartWare International, Inc. Announces Completion of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
4. HeartWare International, Inc. Announces Pricing of Concurrent Public Offerings of Convertible Senior Notes and Common Stock
5. HeartWare International, Inc. Announces Concurrent Public Offerings of Convertible Senior Notes and Common Stock
6. HeartWare to Present at the Canaccord Genuity Cardio/Diabetes & Obesity Conference
7. HeartWare Achieves Primary Endpoint with 92% Success in Pivotal Bridge-to-Transplant Clinical Trial, ADVANCE
8. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
9. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
10. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
11. HeartWare to Report Financial Results for Third Quarter of 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... , Aug. 21, 2014  Vermillion, Inc. (NASDAQ: ... gynecologic cancers and women,s health, has appointed Holly ... Managed Markets. Ms. Bauzon has a proven ... payer coverage for laboratory services companies. She has more ... PerkinElmer, Inc., where she held the position of Director, ...
(Date:8/21/2014)... 2014 /CNW/ - Eisai Limited is pleased to support the ... comic book available in Canada . The ... to educate children and their parents about epilepsy, the most ... more than 300,000 Canadians. Eisai is guided by a corporate ... which the patient is central – there was a need ...
(Date:8/21/2014)... 21, 2014 /PRNewswire-iReach/ -- ScriptPro has been certified ... its Common Security Framework (CSF). According to ... Manager, "We appreciate this rigorous, top-to-bottom audit. Security-minded ... this certification signifies. Our business partners need to ... CSF CERTIFICATION PROCESS: ScriptPro,s internal security processes and ...
Breaking Medicine Technology:Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2Eisai Pleased to Support Canadian Epilepsy Alliance Comic Book that Teaches Children About Epilepsy 2ScriptPro Achieves HITRUST Certification 2
... Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ), ... human disease, announced today that Arthur T. Sands, ... will present at the Stifel Nicolaus Healthcare Conference in ... Eastern Time.  Dr. Sands will provide an overview on ...
... 2011 Reportlinker.com announces that a new market ... Pharmaceutical Distributors - Global ... This register contains information about 2800 ... register includes the following information about the ...
Cached Medicine Technology:Lexicon Pharmaceuticals to Present at Stifel Nicolaus Healthcare Conference 2
(Date:8/23/2014)... CA (PRWEB) August 23, 2014 ... trading system created by Greg Marks has been generating ... earlier this month. The commotion surrounding the new product ... an investigative review. , “In recent years ... trading software systems, commonly referred to as robots or ...
(Date:8/23/2014)... August 23, 2014 GBI Research, the ... “Critical Care Therapeutics in Major Developed Markets to 2020 ... to Drive Market”, which provides in-depth analysis of the ... Italy, Spain, Japan and Canada. The report provides an ... forecasts to 2020. It covers critical care indications that ...
(Date:8/23/2014)... August 23, 2014 Professional kitchen employees, ... study aid in preparing for Food Safety Certification exams ... by Dynamic Path. , Dynamic Path announced the ... includes more than 200 review questions for culinary industry ... designed to cover requirements of the ServSafe® Food Safety ...
(Date:8/23/2014)... Young adults in Athens, GA who find that they have a ... and call the new helpline which can offer support and guidance ... Teen Athens is a wonderful resource for an adolescent drug or ... to end substance abuse once and for all. When a young ... peers when really they should put their faith in a youth ...
(Date:8/23/2014)... (PRWEB) August 23, 2014 Youth substance ... Texas. It’s no different in Houston, TX. Substance abuse ... falling victim to drug and alcohol dependency in higher ... looking to beat substance abuse, but don’t know where ... treatment facility can be a challenge because most treatment ...
Breaking Medicine News(10 mins):Health News:Legal Insider Bot Review Examining Greg Marks’ Trading Software Released 2Health News:Critical Care Therapeutics in Major Developed Markets to 2020 | Researchmoz 2Health News:Critical Care Therapeutics in Major Developed Markets to 2020 | Researchmoz 3Health News:Food Handler Safety Certification Made Easy with Dynamic Path 2Health News:Teenagers in Athens, GA are Locating Addiction Recovery Thanks to New Helpline 2Health News:New Houston Hotline Assisting Juveniles in Locating Dependable Rehabilitation Help 2
... affecting Calcutta has arrived in Delhi and three deaths have ... weeks. //, ,In 2003 there were more than 30 ... reported. , ,N.K. Yadav, deputy health officer, Municipal Corporation ... control. They have hired 1,055 more health workers to check ...
... Cancer Institute had discovered a new molecular explanation for ... the disease called porphyria, the disease that was probably ... ,The Dana-Farber scientists say in a report featured ... the journal Cell that the nutritional component of porphyria ...
... a as paranormal phenomena, may in fact have their roots ... the high incidence of OBE among the general public, not ... of the population have an out-of-body experience (OBE) at some ... physical body from the outside. It isn't uncommon for people ...
... Indian Biotech Company, Biocon to colloborate with Nobex ... oral peptide drug for cardiovascular diseases. The spokesperson ... into global research collaboration // on Tuesday for ... cardiovasculoar diseases. The Biocon press release said, “The ...
... in the September issue of the Harvard Health Letter, ... quick and short working out sessions may not help ... can lead to diseases. To prevent weight gain and ... sessions are required every week. ,Furthermore, some ...
... infection of newborns with herpes type 1 and 2 ... is not an established procedure in most cases., ... the // journal Sexually Transmitted Diseases, researchers in herpes ... STD in Seattle, point out that unlike all comparable ...
Cached Medicine News:Health News:Study Unveils New Insight To The Madness Of King George III 2Health News:Experts Insist That Neonatal Herpes Be Reported Regularly 2
For the quantitative in vitro determination of Inorganic Phosphorous in serum....
For the quantitative in vitro determination of total and direct bilirubin in serum or plasma....
For the quantitative in vitro determination of Anti-Streptolysin-O (ASO) in serum....
For the quantitative in vitro determination of total protein in urine and c.s.f....
Medicine Products: