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 commercially available treatment alternative that enables non-surgical repair for MR.

"Randomized trials provide valuable insight into directing future studies to improve therapy and match new therapies to the appropriate patient," said Donald Glower, M.D., professor of surgery at Duke Medical Center and co-principal investigator of the EVEREST study. "This trial sets a high scientific standard for future percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world."

Overall, EVEREST Investigators have treated more than 350 patients with over 450 MitraClip devices implanted. Clinical data continues to grow and a significant number of three-year follow up results are available as well as four-year data from a smaller group of patients.

Registry data from the initial non-randomized cohort of EVEREST patients continue to indicate MR reduction is maintained over time in the majority of patients, hospital stays are short, fewer complications occur compared to mitral valve surgery and surgical options are preserved if needed.

More information about the EVEREST trial is available at http://www.mitralregurgitation.org.

"This is an important achievement for Evalve on the path to meeting regulatory milestones with the FDA," said Ferolyn Powell, president and chief executive officer of Evalve. "We believe the MitraClip system has the potential to provide patients suffering with MR an important alternative to surgery that will allow them to avoid the associated risks and trauma."

About the MitraClip Procedure

Percutaneous mitral repair with Evalve's MitraClip device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc. -- headquartered in Menlo Park, California -- has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the percutaneous mitral repair procedure using the MitraClip device, visit http://www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com).

The MitraClip system is currently undergoing clinical evaluation in the United States and Canada.

MitraClip and Evalve are registered trademarks of Evalve, Inc.


'/>"/>
SOURCE Evalve, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... NORTHBROOK, Ill. and BOGOTA, Colombia , June 23, 2016  Astellas today announced the ... joins Astellas Farma Brasil as the company,s second affiliate in Latin America . ... ... appointed General Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its first-ever ... Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding work ... Practice and Pediatric Emergency Medicine Practice. , “With this award, we recognize ...
Breaking Medicine News(10 mins):