Navigation Links
New data shows benefits of MitraClip for patients with mitral regurgitation

WASHINGTON, D.C., Oct. 24, 2007 The vast majority of patients who had a successful result with the percutaneous MitraClip device did not need mitral valve surgery three years after their procedure, and many benefited from significantly improved function of the left ventricle (commonly known as reverse remodeling), according to data presented this week at the Cardiovascular Research Foundations (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington, D.C.

During multiple sessions at TCT 2007, researchers participating in the EVEREST II study presented data from a 107-person, non-randomized patient registry. The presentations evaluated the reduction of mitral regurgitation severity with the MitraClip device and the positive impact of this reduction for patients. The ongoing randomized study arm of EVEREST II is evaluating the safety and efficacy of the MitraClip device compared to surgical mitral valve repair or replacement for the treatment of mitral regurgitation (MR; a condition in which blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body). Highlights of the data presented this week include:

36 Month Follow-up Shows Ongoing Effectiveness and Durability

  • 82 percent of patients who had a successful result with the MitraClip device remain free from surgery 36 months after the procedure.

Reduction in Mitral Regurgitation Severity

  • 74 percent of patients with one or more Clips implanted experienced a reduction to ≤ Grade 2+ MR as assessed by the EVEREST Core Laboratory and graded per the American Society of Echocardiography guidelines.

Significant Reverse Remodeling of the Left Ventricle

  • 12 months after a successful MitraClip procedure, significant reverse remodeling of the left ventricle was demonstrated. Reverse remodeling was assessed based on five echocardiographic measures, including left ventricular end-systolic dimension.
  • In line with the reverse remodeling, 94 percent of patients who had a successful result with the MitraClip device had improved or stable New York Heart Association (NYHA) Class at 12 months following the procedure.

Our work to reduce mitral regurgitation with a percutaneous approach continues to produce compelling results, said Ted Feldman, M.D., who presented the 36 month follow-up data at TCT. Dr. Feldman is the EVEREST II national co-principal investigator and director of the cardiac catheterization lab at Evanston Northwestern Healthcare in Evanston, Illinois. The reduction in MR severity achieved, along with the stability of the results at 36 months and the preservation of subsequent surgical options, leads us to believe that the MitraClip device is likely to become a viable first-line option for treating MR in many patients.

Dr. Michael Rinaldi, who presented the reverse remodeling data at TCT, concurred. The reverse remodeling data is important in that it provides compelling, objective evidence that the MitraClip device is having a positive impact on patients, said Dr. Rinaldi, director of clinical research at Sanger Clinic/Carolinas Medical Center. Additionally, patients with the MitraClip report that they feel better and are able to engage more fully in activities they enjoy.

EVEREST Study Continues Enrollment

The EVEREST study continues at more than 35 centers in North America, with more than 300 patients enrolled and more than 300 MitraClip devices implanted to date. Investigators are currently enrolling patients in both arms of the EVEREST II study a randomized, controlled arm and a high risk registry arm with the goal of completing enrollment by the end of 2008.

This study is gathering valuable information that cardiac surgeons and interventional cardiologists have never had before. The data provides new insights about treatment considerations for patients with significant degenerative or functional mitral regurgitation, said Dr. Feldman. We encourage physicians to refer such patients to EVEREST investigators.

Enrollment in the study is open to a range of patients:

  • Patients with either degenerative or functional MR.
  • Patients who are good surgical candidates and are open to the option of a less invasive approach.
  • High risk patients who are not good candidates for surgery will be enrolled in the EVEREST High Risk Registry until enrollment is complete in this arm by the end of 2007.

More information about the EVEREST II trial is available at

Evalve remains focused on completing the EVEREST II trial and making progress toward commercialization of the MitraClip device, said Ferolyn Powell, president and chief executive officer of Evalve. The data underscore that the MitraClip device has the potential to be a valuable alternative to treat patients with mitral regurgitation, providing a less invasive treatment option and enabling patients to avoid the trauma, long recovery times and complications associated with open heart surgery.


Contact: Lorie Fiber
Edelman Public Relations

Related biology news :

1. Novel Asthma Study Shows Multiple Genetic Input Required; Single-gene Solution Shot Down
2. UCLA Study Shows One-Third of Drug Ads in Medical Journals Do Not Contain References Supporting Medical Claims
3. Genome of deadly amoeba shows surprising complexity, evidence of lateral gene transfer
4. “Nano-scissors?laser shows precise surgical capability
5. Novel Enzyme Shows Potential As An Anti-HIV Target
6. Clam embryo study shows pollutant mixture adversely affects nerve cell development
7. New imaging method gives early indication if brain cancer therapy is effective, U-M study shows
8. Study shows nanoshells ideal as chemical nanosensors
9. UCSD Discovery Shows How Embryonic Stem Cells Perform Quality Control Inspections
10. Gene vaccine for Alzheimers disease shows promising results
11. Special Imaging Study Shows Failing Hearts Are Energy Starved
Post Your Comments:
(Date:11/17/2015)... Paris from 17 th ... Paris from 17 th until 19 th ... leader, has invented the first combined scanner in the world ... scanning surface. Until now two different scanners were required: one ... both on the same surface. This innovation is an ...
(Date:11/16/2015)... , Nov 16, 2015  Synaptics Inc. ... human interface solutions, today announced expansion of its ... ™ touch controller and display driver integration ... of smartphones. These new TDDI products add to ... (HD resolution), TD4302 (WQHD resolution), and TD4322 (FHD ...
(Date:11/11/2015)... , Nov. 11, 2015   MedNet Solutions , ... spectrum of clinical research, is pleased to announce that it ... Clinical Trials (PCT) event, to be held November 17-19 ... able to view live demonstrations of iMedNet ... learn how iMedNet has been able to deliver ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... 2015 Cepheid (NASDAQ: CPHD ) today ... following conference, and invited investors to participate via webcast. ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ... New York, NY      Tuesday, December 1, 2015 ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. ... IIROC on behalf of the Toronto Stock Exchange, confirms ... there are no corporate developments that would cause the ... --> --> About Aeterna Zentaris ... . --> Aeterna Zentaris is a specialty ...
(Date:11/24/2015)... -- SHPG ) announced today that Jeff Poulton ... th Annual Healthcare Conference in New York City ... EST (1:30 p.m. GMT). --> SHPG ) announced today ... the Piper Jaffray 27 th Annual Healthcare Conference in ... 2015, at 8:30 a.m. EST (1:30 p.m. GMT). --> ...
(Date:11/24/2015)... ... November 24, 2015 , ... In harsh industrial processes, the ... in-line sensors can represent a weak spot where leaking process media is a ... sensor housings , which are designed to tolerate extreme process conditions. They combine ...
Breaking Biology Technology: