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:5/27/2016)... New York, NY (PRWEB) , ... May 27, 2016 , ... ... the factors of a stroke, which we as a society can control and change. ... a stroke occurs nearly every 40 seconds within the United States. Plus, with an ...
(Date:5/27/2016)... ... ... Beleza Medspa has initiated a new program to assist active duty ... that Coolsculpting is being used for for more than just cosmetic purposes. ... prescribed body-fat standard, measured by the circumference-based tape method. The tape-test is used ...
(Date:5/27/2016)... ... 27, 2016 , ... Each year Standard Process Inc. ... is this year’s Life University winner of a $2,500 scholarship from ... Leadership Awards ceremony. , Outerbridge is approaching her last quarter at Life University ...
(Date:5/26/2016)... ... 2016 , ... There are many ways to cook a hot dog, but ... Americans prefer their dogs straight off the grill. Of the 90 percent of Americans ... to cook a hot dog, far outpacing other cooking methods such as steaming (12 ...
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... AMSTERDAM , May 24, 2016 ... aplicación médica para ayudar a los médicos a compartir ... los pacientes a escala mundial. Profesionales médicos de Europa, ... ya se han apuntado a la aplicación, que combina ... en un entorno totalmente seguro. Educación   ...
(Date:5/24/2016)... CHRISTCHURCH, New Zealand , May 24, 2016 ... scanning and informatics solutions for the healthcare sector, has been ... the New Zealand Hi-Tech Awards 2016. Dr ... a fantastic acknowledgement for our team.  It,s really good to ... the burden healthcare internationally. Our products are used in 35 ...
(Date:5/24/2016)... KONG , May 24, 2016 ... , the world , s first ... AV fistula intervention   OrbusNeich, a global ... has expanded its portfolio to include products to treat ... are the company,s first entry devices for lower limb ...
Breaking Medicine Technology: