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:2/24/2017)... ... February 24, 2017 , ... ... it is so critically important that we all are aware of our options ... Mediaplanet is proud to announce the launch of its newest edition of "Vision ...
(Date:2/24/2017)... ... February 24, 2017 , ... Yisrayl Hawkins, Pastor and ... Bible Prophecy concerning this present generation. Yisrayl makes an astounding statement when he ... He explains that the Bible details the current times so plainly that anyone ...
(Date:2/24/2017)... ... February 24, 2017 , ... Congratulations to Head ... division on February 12th. Ms. Esparza qualified into this prestigious status after ... held in Las Vegas, Nevada. Frida is one of approximately 25 gymnasts in ...
(Date:2/23/2017)... ... 2017 , ... The Lymphoma Research Foundation (LRF) – the ... the lymphoma community through a comprehensive series of education programs, outreach initiatives and ... Beach to host its Swirl: Miami Wine Tasting Event on March 28, 2017. ...
(Date:2/23/2017)... ... 23, 2017 , ... Rosica Communications, a national PR ... media management, corporate communications, SEO and cause marketing, is opening an office in ... Hampshire, Massachusetts and Canada, Rosica will focus on expanding its footprint. , ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... Feb. 23, 2017 ITL Limited, ( ASX: ITD ), ... for the half year ended 31 December 2016 compared with the ... presentation can be viewed here . Highlights ... $1.04m; up 104%) Earnings per share of 2.2 ... of $17.5m (Dec 2015: $15.7m; up 11%) Profit ...
(Date:2/23/2017)... Research and Markets has announced the addition of the "Menopause ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... questions: What are the key drugs marketed ... Global Menopause market? What are the unit prices and ...
(Date:2/23/2017)... Research and Markets has announced the addition of the "Oesophageal ... their offering. ... The latest research Oesophageal Cancer Drugs Price Analysis and Strategies - ... Cancer market. The research answers the following questions: ... Oesophageal Cancer and their clinical attributes? How are they positioned in ...
Breaking Medicine Technology: