Navigation Links
WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD
Date:8/20/2009

SALT LAKE CITY, Aug. 20 /PRNewswire-FirstCall/ -- ("WorldHeart") (Nasdaq: WHRT) - World Heart Corporation (WorldHeart) announced today that it has received FDA conditional approval to begin a bridge-to-transplant (BTT) study of the Levacor Ventricular Assist Device (VAD) at ten US centers.

The company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of clinical center Institutional Review Board (IRB) approvals. WorldHeart has been working closely with a number of clinicians and clinical sites that are interested in participating in the Levacor Study.

Center expansion beyond the initial ten sites will be based upon a supplemental IDE application and subsequent FDA approval. Study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.

"We are extremely pleased to reach this key milestone in the development and clinical implementation of the Levacor VAD," said Mr. J. Alex Martin, WorldHeart's President and CEO. "We are also pleased that the clinical study has been assigned CMS category B2, which makes insurance reimbursement possible. Finally, we believe that our unique assist technology will provide life-saving potential for many heart-failure patients and further advance mechanical circulatory support therapy."

The Levacor VAD is the only bearingless, fully magnetically levitated, implantable centrifugal pump to enter clinical trials. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. As described by Mr. Jal S. Jassawalla, World
'/>"/>

SOURCE World Heart Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. WorldHeart Announces Further Milestone in Miniaturized Assist Pump Development
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... 2015 /PRNewswire/ - YOLO Medical Inc. , ... distribution of medical and aesthetic devices, proudly announces ... YOLO,s new generation body contouring laser system; LIPOFINA. ... second-generation low-level laser device for body contouring, creating ... patented technology while continuing to push the envelope ...
(Date:5/4/2015)... 2015   Mallinckrodt plc (NYSE: MNK ), ... 13, 2015, at the Bank of America Merrill Lynch 2015 ... Las Vegas, Nev. ... Officer, and Cole Lannum , Senior Vice President of ... in a session scheduled to begin at 3 p.m. Eastern ...
(Date:5/4/2015)... 2015  Array BioPharma Inc. (NASDAQ: ARRY ... of its fiscal year ending June 30, 2015. ... noted, "With the close of the Novartis-GSK transaction, ... innovative oncology products in Phase 3, with plans ... These transformative transactions have accelerated our path to ...
Breaking Medicine Technology:YOLO Medical Inc. receives FDA clearance for body contouring laser 2Mallinckrodt To Present At Bank Of America Merrill Lynch 2015 Health Care Conference 2Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 2Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 3Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 4Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 5Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 6Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 7Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 8Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 9Array BioPharma Reports Financial Results For The Third Quarter Of Fiscal 2015 10
... 2011 /PRNewswire-Asia/ -- Shenzhen Wuzhou Changlian International Trading Co., ... & medical equipment, announces its new arrivals of exercise ... indispensable parts for people to easily develop good habits ... cater to those patients or people who feel unwell, ...
... Pain Foundation (APF) today announced the launch of "Explain ... Hispanic Americans about chronic pain and foster improved dialogue ...  A growing body of research demonstrates that minorities, including ... management services and treatments, have their pain documented by ...
Cached Medicine Technology:New Arrivals of Exercise & Health Care Equipment 2American Pain Foundation Launches New Educational Campaign, "Explain Your Pain," to Help Hispanic Americans Better Understand Chronic Pain and Pain Management 2American Pain Foundation Launches New Educational Campaign, "Explain Your Pain," to Help Hispanic Americans Better Understand Chronic Pain and Pain Management 3
(Date:5/4/2015)... San Diego Fertility Center (SDFC) ... brand new, 13,700 square foot facility scheduled to open ... not only provide fertility treatment and services for the ... and educational events to a number of local and ... door to their current Carmel Valley/Del Mar location and ...
(Date:5/4/2015)... 2015 Elisabeth Rosenthal’s article* on ... and showed the healthcare fraternity as well as ... the downside of balance billing. In definition, balance ... billing a patient for the difference between what ... what the provider chooses to charge. Rosenthal’s article ...
(Date:5/4/2015)... For partners who’d like to become ... Astroglide TTC™ (Trying to Conceive) . Unlike traditional ... levels, Astroglide TTC™ is specially formulated to provide a ... Centers for Disease Control, an average of one ... sustaining a pregnancy, and over 7.4 million women ...
(Date:5/4/2015)... 04, 2015 Peacock Alley knows ... He said, “My mother was the most beautiful woman I ... in lovely, feminine prints and textures to remind ... further than the Eloise Robe to get you there. The ... cap sleeve and tapered waist. It is available in small/medium ...
(Date:5/3/2015)... 2015 Barbara Crone has joined Women’s Excellence ... being of the men, women and families who seek her care, ... care for families in the home. , “When ... wondering if I could complete their care with the delivery of ... my mentor Nurse Midwife, I knew it was time for me ...
Breaking Medicine News(10 mins):Health News:San Diego Fertility Center Hosted a Ribbon Cutting Ceremony at Its New, Expanded Facility 2Health News:San Diego Fertility Center Hosted a Ribbon Cutting Ceremony at Its New, Expanded Facility 3Health News:Out of Network Balance Billing Without Being Viewed as Fraud 2Health News:Out of Network Balance Billing Without Being Viewed as Fraud 3Health News:Astroglide Announces the Birth of Its New Baby: Astroglide TTC 2Health News:Astroglide Announces the Birth of Its New Baby: Astroglide TTC 3Health News:Feminine Classics for Mother's Day Gifts from Peacock Alley 2Health News:Women's Excellence In Midwifery Welcomes Barbara Crone 2
... new role for a new type of T cell in ... nerves to make a neurotransmitter (acetylcholine) that blocks inflammation. The ... it may be possible to treat inflammation and autoimmune diseases ... was published this week in Science. "The discovery ...
... AUGUSTA, Ga. Some of the newest therapies in the ... immune system, Georgia Health Sciences University researchers report. These ... cancer by keeping apart two proteins that prevent key immune ... the cover of the Journal of Immunology suggests that these ...
... - The changing tide of Alzheimer,s diagnosis presents new challenges ... out your Alzheimer,s risk, would you want to know? How ... mean for the many newly diagnosed Americans still in the ... can diagnose Alzheimer,s earlier, no effective interventions have been identified ...
... By Steven Reinberg HealthDay Reporter , THURSDAY, Sept. ... will begin earlier this year, so seniors need to ... they want in 2012, U.S. health officials said Thursday. ... the same for the 99.7 percent of Medicare recipients who ...
... a protein linked to cell division and migration and tied ... at high levels in breast cancer specimens and cell lines. ... active in breast cancer cells than in normal breast cells. ... these findings and others in a paper now online in ...
... HealthDay Reporter , THURSDAY, Sept. 15 (HealthDay News) ... tuberculosis, health officials say the disease is less of a ... But, they add, the ease of travel that,s a hallmark ... beyond risk. "Drug-resistant TB exists all over the world," ...
Cached Medicine News:Health News:T cells making brain chemicals may lead to better treatments for inflammation, autoimmune diseases 2Health News:Newest cancer therapies multi-task to eliminate tumors 2Health News:Safeguards needed to prevent discrimination of early Alzheimer's patients in the workplace 2Health News:Enrollment Period for Medicare Starts Early This Year 2Health News:Study finds protein critical to breast cancer cell proliferation, migration 2Health News:Officials Tackle Multidrug-Resistant TB in Europe 2Health News:Officials Tackle Multidrug-Resistant TB in Europe 3
... Pipette is a synonym for pipetting accuracy, ... design, and superior operating comfort. Its single, ... measuring stroke and blow-out as well as ... ensures utmost accuracy and precision. Ejection sleeve ...
... is ideal for repeated pipetting ... volume FInnpipettes offer the same ... Finnpipette Digital pipettes: New, ... Soft-touch tip ejection, Safety label, ...
Inquire...
... A fixed pipette is ... a single volume. Fixed volume ... and advantages as other Finnpipette ... design, Super blow-out (1-40ul), Soft-touch ...
Medicine Products: