Navigation Links
WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor(TM) VAD

SALT LAKE CITY, Jan. 8 /PRNewswire-FirstCall/ -- World Heart Corporation ("WorldHeart"; Nasdaq: WHRT), a developer of mechanical circulatory systems, announced today that it has received unconditional approval from the U.S. Food and Drug Administration ("FDA") for the bridge-to-transplant ("BTT") study of the Levacor Ventricular Assist Device ("VAD"). Study enrollment will encompass 160 subjects, a reduction from the approximately 200 subjects of the original statistical plan. As previously announced, the BTT study will begin initially at ten clinical sites.

"We are especially pleased to receive unconditional approval for the Levacor BTT clinical trial in conjunction with a significant reduction in total sample size," notes Mr. J. Alex Martin, WorldHeart's President and Chief Executive Officer. "Since receiving the FDA's conditional approval, we have been actively working with involved physicians, their hospital administrations and Institutional Review Boards (IRBs) to attain individual center readiness. We have also been providing in-depth surgical and technical training and expect to have our first implant this quarter."

As described by Mr. Jal S. Jassawalla, WorldHeart's Executive Vice President and Chief Technology Officer, "The Levacor VAD is the only fully magnetically levitated, bearingless, implantable centrifugal pump to move into clinical trial." By using magnetic levitation to fully suspend a spinning rotor, the Levacor VAD's only moving part, the pump is designed to eliminate wear and to provide unobstructed clearances for blood flow across a wide range of operation. Mr. Jassawalla said, "We are enthusiastic about the potential for this technology and look forward to demonstrating its safety and efficacy in the upcoming trial."

About World Heart Corporation

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

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 relating to WorldHeart's bridge-to-transplant clinical study of the Levacor Ventricular Assist Device, strategic direction, increase in shareholder value, access to investment capital, its clinical development programs and the product pipeline, and the growth of WorldHeart's overall business, as well as other statements that can be identified by the use of forward-looking language, such as "believes," "feels," "expects," "may," "will," "should," "seeks," "plans," "anticipates," or "intends" or the negative of those terms, or by discussions of strategy or intentions. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation: WorldHeart's need for additional capital in the future; risks in product development, regulatory approvals 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-K for the year ended December 31, 2008 and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2009, June 30, 2009 and September 30, 2009.

SOURCE World Heart Corporation



SOURCE World Heart Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. WorldHeart Signs Agreements for Next-Generation Minimally Invasive Blood Pump
2. WorldHeart Receives IRB Approval at First Center in the Levacor(TM) VAD BTT Clinical Trial
3. WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD
4. WorldHeart Announces Further Milestone in Miniaturized Assist Pump Development
5. VIA Pharmaceuticals Receives Delisting Notification From NASDAQ
6. KV Pharmaceutical Receives Permission from NYSE for its Securities to Continue Trading on the NYSE until March 31, 2010
7. AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Gram-Negative Bloodstream Pathogens
8. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
9. The Make-A-Wish Foundation(R) Receives $1 Million Donation from LATISSE(R) Wishes Campaign
10. BASFs Aseptrol(R) S10 - Tab Receives EPA Approval For H1N1 Sanitization Label
11. CareCentrix Receives URAC Health Utilization Management Accreditation
Post Your Comments:
(Date:6/23/2016)... June 23, 2016 The vast majority of ... dialysis facility.  Treatments are usually 3 times a week, ... visit, including travel time, equipment preparation and wait time. ... especially grueling for patients who are elderly and frail.  ... nursing and rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... FRANKLIN, Tenn. , June 23, 2016 ... for automating, integrating and transforming the patient ... launch of several innovative new products and ... depth of its revenue cycle offerings. These ... establish more efficient workflows, remain compliant in ...
(Date:6/23/2016)... 23, 2016  The National Pharmaceutical Council (NPC) ... health policy research organization as its newest member.  ... senior vice president and chief scientific officer, Mallinckrodt ... the NPC Board of Directors. ... has joined us in support of our efforts ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton Memorial ... Plant City Observer , brings up a new, often overlooked aspect of head lice: the ... closing for fumigation is not a common occurrence, but a necessary one in the event ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
Breaking Medicine News(10 mins):