Navigation Links
Evalve Announces Enrollment Completion of the EVEREST Randomized Study
Date:9/30/2008

EVEREST Becomes First Trial of its Kind to Achieve Enrollment Milestone

MENLO PARK, Calif., Sept. 30 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the completion of randomized enrollment in the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating the MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide.

"The completion of enrollment in the randomized trial is an important milestone for the field of cardiology," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Northwestern Hospital and co-principal investigator of the trial. "It is the first randomized trial of any percutaneous mitral repair device compared to mitral valve surgery, and also the first large prospective evaluation of current mitral valve surgery using an independent core laboratory."

EVEREST is a U.S. Food and Drug Administration (FDA) approved Phase II randomized, controlled, multi-center clinical research study in the United States and Canada evaluating the safety and efficacy of the MitraClip device in 279 patients with moderate-to-severe (3+) or severe (4+) MR, as compared to surgical repair or replacement. The study effectiveness endpoint requires an MR reduction to less than or equal to 2+ at one year. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe or severe mitral regurgitation at 12 months. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or hospital discharge whichever is longer.

Evalve received CE Mark approval for the MitraClip device earlier this year and the first series of patients were recently treated in Germany. The MitraClip system is the only comme
'/>"/>

SOURCE Evalve, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... to Millennium Research Group (MRG), the global authority ... United States and European transcatheter embolization ... through 2022, with embolization particles representing one of ... drug-eluting beads (DEBs) and radioembolization spheres in interventional ...
(Date:1/15/2014)...  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") ... its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), for ... Solta Medical, Inc. (NASDAQ: SLTM ) ("Solta") ...
(Date:1/15/2014)... , Jan. 15, 2014  Zafgen, Inc., a leading ... of severely obese patients, today announced initial results ... selective inhibitor of methionine aminopeptidase 2 (MetAP2), in ... of genetic obesity.  These results showed improvements in ...
Breaking Medicine Technology:US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4
... England, July 29, 2011 , ... The UK bioindustry has raised over $250m in financing ... any quarter for one year, and the second largest amount raised ... to the financing drought that saw three consecutive quarters below $100m ...
... Health Company (Nasdaq: FHCO ) today announced that ... operating results for the third quarter and first nine months ... Eastern Time (EDT).  The Company expects to report its operating ... other interested parties may participate in the conference call by ...
Cached Medicine Technology:UK Chalks Up $253 Million in Investment in Q2 2011: Oxford Cluster Takes the Largest Bite of the Apple 2UK Chalks Up $253 Million in Investment in Q2 2011: Oxford Cluster Takes the Largest Bite of the Apple 3The Female Health Company to Host Third Quarter Conference Call on Friday, August 5, 2011 2
(Date:7/10/2014)... health concerns in the United States, with 32 percent ... 2012. As health problems such as childhood obesity grow, ... the problem. , A new study, led by Jenine ... at Washington University in St. Louis, examined the use ... conversations about the issue of overweight kids. , The ...
(Date:7/10/2014)... For those students looking to bump up their ... be spending more time in a library or study ... University research shows that students who were members of ... during their freshman and sophomore years had higher GPAs ... indicated that students with memberships stayed in school longer. ...
(Date:7/10/2014)... Alba,s research at the University of Huddersfield could help ... popular emulsion-based food products such as butter, mayonnaise, ... to gain an international profile for her work. , ... science at the University and now she has embarked ... supervisor, Dr Vassilis Kontogiorgos, she is investigating the potential ...
(Date:7/10/2014)... at Rutgers University-Newark says the human brain operates much ... finding that could provide a better understanding of schizophrenia, ... afflict an estimated 13.6 million Americans. , In newly ... Cole, an assistant professor at the Center for Molecular ... of a person at rest is basically the same ...
(Date:7/10/2014)... at the Bellvitge Biomedical Research Institute (IDIBELL) and the ... 19 patients a new therapeutic combination to combat resistant ... new treatment could stabilize the growth of these tumors ... Journal of Cancer ., Sarcomas , Sarcomas are ... are several subtypes. It can affect from children to ...
Breaking Medicine News(10 mins):Health News:Study looks at how Twitter can be used to address specific health issues 2Health News:Want a higher GPA in college? Join a gym 2Health News:World interest in research work on the benefits of the Okra plant 2Health News:Working to loosen the grip of severe mental illness 2Health News:New therapeutic combination to slow resistant sarcomas 2
... protein pathway that may hold the secret to understanding ... State University researchers. Anumantha Kanthasamy, a distinguished professor ... R. Lloyd Endowed Chair in Neurotoxicology at the ISU ... the complex mechanisms of the disease for more than ...
... (HealthDay News) -- A new study finds that heart attack ... other heart attack patients to receive priority care at emergency ... patients admitted to 96 hospitals in the province of Ontario ... had a history of depression recorded in their medical charts. ...
... the U.S. Department of Energy,s (DOE) Brookhaven National Laboratory reveals ... compulsively overeat, or binge: In binge eaters but not ordinary ... triggers a spike in dopamine - a brain chemical linked ... February 24, 2011, in the journal Obesity - ...
... is available in German . , More ... a minimally invasive manner. A small incision in the abdominal ... insert the instrument and make the organs visible with an ... body as much as traditional surgeries do. However, these minimally ...
... , MONDAY, Feb. 28 (HealthDay News) -- Cancer ... accompanying muscle loss and malnutrition by taking fish oil ... The finding is based on a small study ... hope that a simple, noninvasive intervention might go a ...
... 70 and older have hearing loss, but those who are ... this loss, according to a new study led by Johns ... online Feb. 28 in the Journal of Gerontology: Medical Sciences, ... survey in older adults on this often ignored and underreported ...
Cached Medicine News:Health News:ISU research raises hope for solving Parkinson's disease puzzle 2Health News:Heart Patients With Depression Often Find ER Delays 2Health News:Binge eaters' dopamine levels spike at sight, smell of food 2Health News:Binge eaters' dopamine levels spike at sight, smell of food 3Health News:Minimally invasive surgeries: Laser suturing 2Health News:Minimally invasive surgeries: Laser suturing 3Health News:Fish Oil Seems to Help Cancer Patients Preserve Muscle 2Health News:Fish Oil Seems to Help Cancer Patients Preserve Muscle 3Health News:Hearing loss rate in older adults climbs to more than 60 percent in national survey 2
... for the mid- to high-volume lab, the ... can reduce time-consuming manual tasks by as ... performs random access, STAT, HCFA panels and ... including Stat chemistries, General chemistries, TDMs, DATs, ...
... It takes powerful technology to ... safety, and still lower costs. ... LX20 PRO, offering features that ... any other chemistry analyzer, including ...
... This user-friendly instrument ... Plasma Protein analyzer for ... It is a well ... reliable results for a ...
For Detection of Bile Component in Reflux Disease...
Medicine Products: