Navigation Links
WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD
Date:1/8/2009

OAKLAND, Calif., Jan. 8 /PRNewswire-FirstCall/ -- (Nasdaq: WHRT) World Heart Corporation ("WorldHeart") announced today that it has submitted an Investigational Device Exemption ("IDE") application to the US Food and Drug Administration ("FDA" or the "Agency") for a pivotal Bridge-to-Transplant ("BTT") study of the Levacor(TM) Ventricular Assist Device ("VAD").

The IDE application includes detailed device information, including design and in vitro and in vivo preclinical testing protocols and results. The submission also encompasses an Investigational Plan and extensive study-related materials. The Levacor VAD is intended for use, inside and outside of the hospital, as a BTT in cardiac transplant candidates with presumed non-reversible left ventricular failure. The proposed primary study endpoint comprises survival to heart transplantation, explant for myocardial recovery, or survival to 180 days on device support.

"This IDE submission marks an important milestone for WorldHeart," commented Mr. Jal S. Jassawalla, President and CEO of WorldHeart. "We look forward to the FDA's initial review of this submission and will answer, in supplemental submissions, any Agency questions or requests. We are eager to progress to the clinical study stage in collaboration with many key clinicians in this field who have expressed a strong interest in participating."

WorldHeart's Levacor VAD, a fourth-generation rotary VAD, is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump to have seen clinical use. In contrast with second- and third-generation pumps with blood-immersed mechanical or hydrodynamic bearings, the Levacor uses full magnetic levitation to suspend the spinning rotor, eliminating wear within the pump and allowing greater clearances around the rotor for blood flow.

About World Heart Corporation

WorldHeart is a developer of mechanical circulatory support systems. WorldHeart is headquartered in Oakland, California, USA with additional facilities in Salt Lake City, Utah and Herkenbosch, The Netherlands. WorldHeart's registered office is Ottawa, Ontario, Canada.

Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include all statements regarding WorldHeart's ability to obtain FDA approval for the Levacor(TM) VAD and the conduct of the proposed clinical study, as well as other statements that can be identified by the use of forward-looking language, such as "will" or "intends", or by discussions of strategy or intentions. Investors are cautioned that all forward looking statements involve risk and uncertainties, including without limitation: WorldHeart's ability to obtain FDA approval for the Levacor(TM) VAD, risks in product development and market acceptance of and demand for WorldHeart's products; and other risks detailed in WorldHeart's filings with the U.S. Securities and Exchange Commission, including without limitation its Annual Report on Form 10-KSB/A for the year ended December 31, 2007 and its Quarterly Report on Form 10-Q/A for the quarter ended March 31, 2008 and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2008 and September 30, 2008.


'/>"/>
SOURCE World Heart Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. WorldHeart Regains Compliance With the Minimum Bid Price Rule
2. WorldHeart Receives Notice From the NASDAQ Stock Market Regarding Non-Compliance With Marketplace Rule 4310(c)(7)
3. WorldHeart Announces Effectiveness of Reverse Stock Split
4. WorldHeart Receives Favorable Decision to Continue NASDAQ Listing
5. WorldHeart Receives Non-Compliance Letter From NASDAQ Stock Market
6. WorldHeart Announces Voluntary Delisting from the Toronto Stock Exchange
7. WorldHeart Announces Possible Delisting Action by NASDAQ
8. WorldHeart Notified of TSX Delisting Review
9. WorldHeart Appoints David Pellone Chief Financial Officer
10. Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
11. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... , ... June 27, 2016 , ... "FCPX editors can ... inside of Final Cut Pro X," said Christina Austin - CEO of Pixel Film ... Final Cut Pro X users can now reveal the media of their ...
(Date:6/27/2016)... ... June 27, 2016 , ... A ... revolutionize the emergency ambulance transport experience for the millions of people who require ... has disrupted the taxi industry through the use of technology. Now, SmartEMS has ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
(Date:6/23/2016)... , June 23, 2016  Guerbet announced today that ... Supplier Horizon Award . One of ... was recognized for its support of Premier members through ... clinical excellence, and commitment to lower costs. ... this recognition of our outstanding customer service from Premier," ...
Breaking Medicine Technology: