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 blo
'/>"/>

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

Page: 1 2

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:9/2/2014)... Recently, BambooIndustry.com, an excellent company in ... strand woven bamboo floors to celebrate the ... its appreciation to the frequent callers, BambooIndustry.com launched a ... addition to strand woven floors, BambooIndustry.com provides many kinds ... floors, click strand woven floors, click lock floors, wide ...
(Date:9/2/2014)... EDT): In a Viewpoint published today in the ... of Boston researchers call for the implementation of taxes ... States. The researchers from the Friedman School of Nutrition ... Boston Children,s Hospital write that policies taxing nearly all ... people make meaningful dietary changes and substantially reduce health ...
(Date:9/2/2014)... 2014 TCG, a leading government technology strategy ... one of the fastest-growing companies in America for the seventh ... was previously recognized in 2013, 2012, 2011, 2010, 2009, 2008, ... grown 86% from 2010 to 2013, ranking the company at ... in America - up 635 spots from 2013! More information ...
(Date:9/2/2014)... 2014 The use of Xarelto (known ... growing at a rapid pace, even as Xarelto ... around the U.S., Bernstein Liebhard LLP reports. According to ... within a year of its 2011 launch, patients were ... a blood thinner that has been in use for ...
(Date:9/2/2014)... Complications are rare among breast cancer patients who ... However, the researchers did find that a ... risk for certain complications than a single mastectomy. ... cancer patients who had a single (64 percent) ... were followed for 30 days after surgery. ...
Breaking Medicine News(10 mins):Health News:Cheap Strand Woven Bamboo Floors For Autumn On Sale At BambooIndustry.com 2Health News:Taxes and subsidies could encourage healthier diet and lower healthcare costs 2Health News:TCG One of the Fastest-Growing Companies in America – for the Eighth Time! 2Health News:Xarelto Lawsuit News: Bernstein Liebhard LLP Comments on Growing Use of Xarelto in Spite of Mounting Product Liability Litigation 2Health News:Xarelto Lawsuit News: Bernstein Liebhard LLP Comments on Growing Use of Xarelto in Spite of Mounting Product Liability Litigation 3Health News:Xarelto Lawsuit News: Bernstein Liebhard LLP Comments on Growing Use of Xarelto in Spite of Mounting Product Liability Litigation 4Health News:Complication Rates Low With Mastectomy, Breast Reconstruction: Study 2
... VA (March 29, 2011) Medicare coverage and ... to as virtual colonoscopy, has tripled in recent years, ... the Journal of the American College of Radiology ... to produce a three-dimensional visualization that permits a thorough ...
... -- New Orleans residents still faced a threefold higher ... was devastated by Hurricane Katrina in 2005, a study ... home and a poorly functioning health system likely contribute ... two-year post-Hurricane Katrina analysis of nearly 30,000 people. ...
... the risk of breast cancer, but the risk differs by ... analysis of the Women,s Health Initiative observational study. ... observed in non-obese women, but not in obese women. The ... body mass index (BMI) or waist circumference. Juhua ...
... that metabolic syndrome, a constellation of conditions that increases ... increase the risk of the two most common types ... AACR 102nd Annual Meeting 2011, held here April 2-6. ... the National Cancer Institute, said approximately one-third of the ...
... By Amanda Gardner HealthDay Reporter , SATURDAY, ... the ancient art of yoga appeared to halve the number ... atrial fibrillation. Three sessions of yoga a week ... and depression which often plagues patients with this condition, according ...
... 3 (HealthDay News) -- The use of a powerful ... the United States over the past five years, a ... drugs -- widely regarded as the last option for ... cause for concern because carbapenem-resistant bacteria are becoming more ...
Cached Medicine News:Health News:Nationwide utilization of virtual colonoscopy triples, study suggests 2Health News:Heart Attack Risk Plagues Post-Katrina New Orleans 2Health News:Smoking did not influence breast cancer risk among obese women 2Health News:Metabolic syndrome may increase risk for liver cancer 2Health News:Yoga May Also Calm a Dangerous Irregular Heartbeat 2Health News:Yoga May Also Calm a Dangerous Irregular Heartbeat 3Health News:Research Warns of Overuse of Powerful Class of Antibiotics 2
(Date:9/2/2014)... 2014 Reportbuyer.com has added a new ... Technologies for Molecular Imaging Devices ... The objectives of this study are to ... used for diagnostic purposes, present global market measurements ... market segments as well as forecast market and ...
(Date:9/2/2014)... , Sept. 2, 2014 Reportlinker.com ... available in its catalogue: Asia-Pacific ... http://www.reportlinker.com/p02353210/Asia-Pacific-Infusion-Therapy-Device-Market.html Abstract: The ... therapy devices included volumetric infusion pumps, syringe infusion ... connectors and stopcocks. These categories are segmented based ...
(Date:9/2/2014)... 2, 2014 The Pharmaceutical Care Management Association ... (PBMs), today filed a lawsuit in Iowa ... Iowa law that restricts tools used ... state,s employers and consumers.  The law—HF ... restricting the use of Maximum Allowable Cost (MAC) lists ...
Breaking Medicine Technology:Global Markets and Technologies for Molecular Imaging Devices 2Global Markets and Technologies for Molecular Imaging Devices 3Global Markets and Technologies for Molecular Imaging Devices 4Global Markets and Technologies for Molecular Imaging Devices 5Global Markets and Technologies for Molecular Imaging Devices 6Global Markets and Technologies for Molecular Imaging Devices 7Global Markets and Technologies for Molecular Imaging Devices 8Global Markets and Technologies for Molecular Imaging Devices 9Global Markets and Technologies for Molecular Imaging Devices 10Global Markets and Technologies for Molecular Imaging Devices 11Global Markets and Technologies for Molecular Imaging Devices 12Global Markets and Technologies for Molecular Imaging Devices 13Global Markets and Technologies for Molecular Imaging Devices 14Global Markets and Technologies for Molecular Imaging Devices 15Global Markets and Technologies for Molecular Imaging Devices 16Global Markets and Technologies for Molecular Imaging Devices 17Global Markets and Technologies for Molecular Imaging Devices 18Global Markets and Technologies for Molecular Imaging Devices 19Global Markets and Technologies for Molecular Imaging Devices 20Global Markets and Technologies for Molecular Imaging Devices 21Global Markets and Technologies for Molecular Imaging Devices 22Global Markets and Technologies for Molecular Imaging Devices 23Global Markets and Technologies for Molecular Imaging Devices 24Global Markets and Technologies for Molecular Imaging Devices 25Asia-Pacific Infusion Therapy Device Market 2Asia-Pacific Infusion Therapy Device Market 3Asia-Pacific Infusion Therapy Device Market 4Asia-Pacific Infusion Therapy Device Market 5Asia-Pacific Infusion Therapy Device Market 6Asia-Pacific Infusion Therapy Device Market 7Asia-Pacific Infusion Therapy Device Market 8Asia-Pacific Infusion Therapy Device Market 9Asia-Pacific Infusion Therapy Device Market 10Asia-Pacific Infusion Therapy Device Market 11Asia-Pacific Infusion Therapy Device Market 12
... ZURICH, December 9, 2011 NHS National ... ALFApump System Sequana Medical announced today the ... System commissioned by the National Innovation Centre, the NHS ... up the development and use of innovations that will ...
... ATLANTA, Dec. 8, 2011 CardioMEMS announced today that ... Devices advisory panel voted against the Champion Heart Failure ... allows cardiologists to monitor heart failure patients from their ... is safe with a vote of 9-1, the majority ...
Cached Medicine Technology:NHS National Innovation Centre Estimates Sequana Medical's ALFApump® System Could Save the NHS £50 Million in ascites Care Annually 2FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure Management System for Patients With Heart Failure 2FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure Management System for Patients With Heart Failure 3
... the PROTG® GPS™ Self-Expanding Nitinol ... delivered on a commitment to ... PROTG GPS Stents take that ... by adding tantalum markers at ...
Colloidal Gold Conjugated, Streptavidin - 12 OD...
Patent Pending lateral flow assay platform that contributes to increased sensitivty...
Gold Labeling kit for antibodies, the Coat-Block-Run Conjugation Kit pH 8-11; contains 1 bottle each of 20 nm and 40 nm Naked Gold...
Medicine Products: