Navigation Links
JARVIK HEART Announces FDA Conditional Approval of Trial Using the Jarvik 2000® Heart for Destination Therapy
Date:2/27/2012

NEW YORK, Feb. 27, 2012 /PRNewswire/ -- JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced conditional FDA approval of its Pivotal Trial for evaluation of the Jarvik 2000® heart for destination therapy (DT). Use of the device for DT means that it will provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant. The approval permits fifty medical centers to participate in the study. Each medical center may begin enrolling patients immediately upon approval by their Institutional Review Board.

(Photo: http://photos.prnewswire.com/prnh/20120227/NY60355)

Prior to full FDA approval of the trial, the company must submit additional information concerning statistical analysis and conduct of the study, as well as some additional engineering data.

The trial will randomize up to 350 study subjects to either the treatment group, in which patients receive the Jarvik 2000 intraventricular heart assist device, or the control group, in which patients receive the HeartMate® II left ventricular assist device (LVAD), the most widely used FDA-approved LVAD for DT. Patients will be followed for two years to assess primary endpoint success, generally defined as survival free of disabling complications. If the data analysis at two years, or at a prior interim analysis, establishes non-inferiority of the Jarvik 2000 compared to the control, the trial will be judged successful. Additionally, the patients will be followed for another year and the rates of serious infection related to the power cable and pump pocket will be analyzed for the three years since implant. Regarding device-related infection, the analysis is designed to determine if the Jarvik 2000 that uses a unique behind-the-ear power cable and has no pump pocket is superior to the HeartMate II, w
'/>"/>

SOURCE JARVIK HEART, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. 1,000th Implant of the Worlds Only Approved Total Artificial Heart Performed
2. Boston Scientific Receives Industrys First FDA Approval for Drug-Eluting Coronary Stent Use in Heart Attack Patients
3. The Wisconsin Heart Hospital Becomes the Worlds First to Use the Leonardo 3D Vision™ System
4. Total Artificial Heart Patient Receives Donor Heart 15 Years After Decision to Donate Wifes Organs
5. Celladon Corporation Completes $43 Million Financing to Advance MYDICAR® for the Treatment of Heart Failure
6. Mercy Jets Celebrates Heart Month With Charitable Donations
7. HeartWare Schedules Fourth Quarter Conference Call and Webcast
8. In Honor of American Heart Month, Joy Behar & Daughter Eve Call on Women to Take the ProHeart Pledge on Facebook
9. Allscripts Invites Developers to Million Hearts Initiative
10. Heart Hospital of Austin Opens Heart Valve Clinic, Among First Sites in U.S. to Receive New Trans-Catheter Aortic Valve Replacement Technology Since FDA Approval
11. LoneStar Heart Inc. Names Andrew J. Coats, M.D., and Mark Maciejewski to Its Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... , Jan. 22, 2015  ViewRay™, a privately held ... into an exclusive distributor agreement with ITOCHU Corporation (Tokyo ... therapy system for the treatment of cancer in ... system, is the world,s first and only MRI-guided radiation ...
(Date:1/22/2015)... 22, 2015  Amgen (NASDAQ: AMGN ) today announced that ... results on Tuesday, Jan. 27, 2015, after the close of the ... call with the investment community at 2 p.m. PT. Participating in ... chairman and chief executive officer, and other members of Amgen,s senior ...
(Date:1/22/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/x3hp3g/microbiology ... "Microbiology Testing/Clinical Microbiology Market by Product, Clinical Application ... report to their offering. Clinical ... for the detection of infectious diseases. The respiratory ...
Breaking Medicine Technology:ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 3
... Reached in Key Lung Compartments, REINACH and ... Ltd. today announced promising,results of "first-in-man" studies ... a total of 19 healthy male,volunteers. , ... using Microdosing,for the determination of drug concentrations ...
... /PRNewswire-FirstCall/ -- ADVENTRX,Pharmaceuticals, Inc. , a ... commercializing proprietary product,candidates for the treatment ... that results from preclinical studies of ... (5-FU),and capecitabine (Xeloda(R)), an oral prodrug ...
Cached Medicine Technology:Arpida Announces Promising Results of "First-In-Man" Studies With,AR-709 2Arpida Announces Promising Results of "First-In-Man" Studies With,AR-709 3Arpida Announces Promising Results of "First-In-Man" Studies With,AR-709 4Arpida Announces Promising Results of "First-In-Man" Studies With,AR-709 5ADVENTRX to Present CoFactor Multiagent Therapy Data at AACR Annual,Meeting 2ADVENTRX to Present CoFactor Multiagent Therapy Data at AACR Annual,Meeting 3
(Date:1/22/2015)... Hollywood, California (PRWEB) January 22, 2015 The City ... 2015 at 10 a.m., to commemorate the 42nd anniversary of the ... United States. , “It’s been 42 years since the Roe vs. ... choose is still as present as ever,” said City of West ...
(Date:1/22/2015)... The Incredible Bulk is a revolutionary method ... lean muscle by up to 30lbs in less than 12 ... HealthyandFitZone.com’s Stan Stevenson, prompting an investigative review. , “Our ... scientific diet formula that allows the body to pack on ...
(Date:1/22/2015)... 2015 Juvent Sports ( http://www.juventsports.com ) ... PGA Merchandise Show to bestow a Juvent Sports Achievement ... golfer, Arlene McKitrick. The award commemorated and congratulated McKitrick ... win. She won her first amateur tournament in 1979 ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Carinsurancesavings.biz has released ... accidental death and dismemberment insurance . , Purchasing an ... can be very advantageous. This type of rider provides benefits ... dismemberment can be considered a lesser form of life insurance. ...
(Date:1/22/2015)... Palm City, Florida (PRWEB) January 22, 2015 ... use cold therapy machine with patented IsoTube design to treat ... has introduced the most progressive and easy to use ... help treat post-operative and sports related orthopedic and muscle injuries. ...
Breaking Medicine News(10 mins):Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2
... (HealthDay News) -- Women, but not men, with post-traumatic ... hormone, new research shows. The hormone -- pituitary ... central nervous system activity, metabolism, blood pressure, pain sensitivity ... in the Feb. 24 issue of Nature , ...
... HealthDay Reporter , WEDNESDAY, Feb. 23 (HealthDay ... pain -- an increasingly controversial treatment that has exploded ... to higher rates of permanent disability for worker,s compensation ... finds. Researchers randomly selected 725 people with low ...
... collaboration is bringing surgical patients closer to having ... trial, patients given neosaxitoxin, a new local anesthetic ... and recovered about two days sooner than those ... on this finding, Children,s Hospital Boston, a co-investigator ...
... of breast cancer survivors battle persistent fatigue, a Michigan ... a technique where physical pressure is applied to acupuncture ... can help alleviate symptoms. Gwen Wyatt will study ... two acupressure treatments on persistent cancer-related fatigue, a state ...
... - While studying one tumor-suppressing protein, Cheryl Walker,s research ... Center came across a separate surprise. They found another ... moonlighting out in the cell,s cytoplasm. Following up ... protein ATM has a second job controlling and killing ...
... San Francisco, CA February 22, 2011 The ... million in research grants as part of its Mobilizing ... populations with chronic diseases through the use of mobile-phone ... $250,000 each, will support studies on diabetes care and ...
Cached Medicine News:Health News:Spinal Fusion Surgery May Leave Some Back Pain Patients Worse Off: Study 2Health News:Spinal Fusion Surgery May Leave Some Back Pain Patients Worse Off: Study 3Health News:New long-acting local anesthetic derived from algae effectively blocks pain in surgical patients 2Health News:New long-acting local anesthetic derived from algae effectively blocks pain in surgical patients 3Health News:Acupressure shows promise in relieving fatigue in cancer survivors 2Health News:UT MD Anderson discovery wins 2010 Cozzarelli Prize 2Health News:McKesson Foundation awards $1.3 million in 6 Mobilizing for Health Research grants 2
... drainage from the ureteropelvic junction to ... packages. Intended for one-time use. CAUTION: ... Sof-Flex® stents must not remain indwelling ... stents must not remain indwelling more ...
... Pigtail Ureteral Stents have an exclusive ... migration. They also feature unique Tecoflex® ... savings. Each Classic Double PigTail Ureteral ... PigTail Ureteral Stent with attached braided ...
The Needle Loading Platform / Shield is designed to provide superior operator shielding during the loading of prostate implant needles with iodine or palladium seeds. It is constructed of 3/8" alumin...
The seed alignment tray aligns seeds and spacers for easy access to be picked up by the SeedVac™. It also interfaces with the seed sterilization and sorting tray for protection from radiation....
Medicine Products: