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Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To U.S. Clinical Trial Of Transcatheter Heart Valve
Edwards Lifesciences
Corporation (NYSE: EW), the world leader in the science of heart valves,
announced that it has received conditional approval from the U.S.
Food and Drug Administration (FDA) for a revised design to the U.S. pivotal
clinical trial of the Edwards SAPIEN transcatheter aortic heart valve
technology. The FDA approved the addition of the Ascendra transapical
delivery system to the trial, and also granted permission to Edwards to
increase its trial sample size from 600 patients to 1,040 patients.
The PARTNER (Placement of AoRTic traNscathetER valves) trial, initiated
in the second quarter of 2007, is evaluating the Edwards SAPIEN valve in
patients who are considered high risk or inoperable for conventional
open-heart valve surgery.
"The addition of the Ascendra transapical delivery system to the
PARTNER trial will enable Edwards to address a larger population of
patients who may have few or no options for treatment of their heart valve
disease," said Michael A. Mussallem, Edwards Lifesciences' chairman and
CEO. "Incorporating Ascendra along with increasing the number of patients
in the trial also will better ensure that the trial endpoints are
successfully met."
With these trial revisions, patients with symptomatic, calcific aortic
stenosis -- a narrowing of the aortic valve that reduces the outward flow
of oxygenated blood -- will be evaluated for inclusion in one of two
separate treatment arms, surgical or medical management. "The addition of
the transapical approach to the PARTNER trial is an important milestone for
cardiac surgeons and their patients. The transapical approach greatly
expands the options for patients who need aortic valve replacement, but
face excessive risk with alternative approaches," said Craig Smith, M.D.,
Chief of the Division of Cardiothoracic Surgery at New York-Presbyterian
Hospital/Columbia University Medical Center and the co-principal
investigator for the U.S. PARTNER trial.
The surgical arm of the trial evaluates the Edwards SAPIEN valve and
the two transcatheter delivery systems -- Ascendra for transapical access,
and RetroFlex for transfemoral access -- as compared to surgical,
open-heart valve replacement. The medical management arm of the trial
evaluates the Edwards SAPIEN valve with the RetroFlex transfemoral delivery
system as compared to appropriate medical therapy.
Edwards has significant experience with transcatheter valve procedures
based on more than 600 implants of the transcatheter heart valve through a
series of extensive clinical trials and feasibility studies in Europe, the
U.S. and Canada. The Edwards SAPIEN valve with the Ascendra transapical and
RetroFlex transfemoral delivery systems is commercially available in
Europe.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease
treatments, is the number-one heart valve company in the world and the
global leader in acute hemodynamic monitoring. Headquartered in Irvine,
Calif., Edwards focuses on specific cardiovascular disease states including
heart valve disease, vascular disease and critical care technologies. The
company's global brands, which are sold in approximately 100 countries,
include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT
Magna and Swan-Ganz. Additional company information can be found at
http://www.edwards.com.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. These forward-looking statements include,
but are not limited to the company's ability to successfully complete the
PARTNER clinical trial, timely regulatory approval of the Edwards SAPIEN
transcatheter aortic heart valve and the market for transcatheter
technologies. Forward-looking statements are based on estimates and
assumptions made by management of the company and are believed to be
reasonable, though they are inherently uncertain and difficult to predict.
Forward-looking statements involve risks and uncertainties that could
cause actual results or experience to differ materially from that expressed
or implied by the forward-looking statements. Factors that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements are detailed in the company's
filings with the Securities and Exchange Commission including its Annual
Report on Form 10-K for the year ended December 31, 2006.
Ascendra, Edwards, Edwards SAPIEN and RetroFlex are trademarks of
Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E
logo, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT
Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and
are registered in the United States Patent and Trademark Office.
Edwards Lifesciences
http://www.edwards.com
Edwards Lifesciences primeºte aprobarea FDA pentru a adãuga Transapical sistem de livrare a SUA studiu clinic de Transcatheter inima Valve - Edwards Lifesciences Receives FDA Approval To Add Transapical Delivery System To U.S. Clinical Trial Of Transcatheter Heart Valve - articole medicale engleza - startsanatate