Healthcare Industry News:  mitral regurgitation 

Devices Interventional Cardiology

 News Release - September 22, 2009

MitraClip(R) Therapy Data Demonstrate Significant Left Ventricular Reverse Remodeling in Patients With Sustained Reduction of Mitral Regurgitation

12-Month Data Presented at TCT 2009 Show Significant Improvement in Left Ventricular Function with no Change in Annular Dimensions

SAN FRANCISCO, Sept. 22 -- (Healthcare Sales & Marketing Network) -- Sustained reduction of mitral regurgitation following mitral valve repair with the MitraClip(R) system in patients with degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR) led to heart function improvements, according to 12-month data from a subset of the initial registry cohort of the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) studies presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

The data were presented today by Scott Lim, M.D., interventional cardiologist at the University of Virginia Medical Center and one of the EVEREST trial investigators. The EVEREST study was designed to evaluate the MitraClip(R) system for the treatment of MR.

This subset of the initial EVEREST registry cohort was comprised of 79 patients with moderate-to-severe (grade 3+) or severe (grade 4+) MR who had discharge MR reduction to grade 2+ or less. Of the 79 patients, 73 percent had DMR and 27 percent had FMR, and 49 continued with a MitraClip(R) device with MR less than or equal to grade 2+ at 12 months. Matched core laboratory echocardiographic data was available at baseline and 12 months. Mean MR grade reduced from 3.1+/-0.7 at baseline to 1.4+/-0.5 at 12 months. Multiple indices of left ventricle function improved significantly (LV volumes, LV mass, LV sphericity and forward stroke volume), and there was no significant change in annular dimensions.

"The 12 month data seen here in the initial cohort continue to add to the body of clinical evidence that demonstrate that the MitraClip(R) therapy may be a clinically beneficial treatment for patients suffering from degenerative or functional MR," said Dr. Lim. "The results we have seen in the EVEREST trials potentially expand the range of treatment options available to select patients, including those who are not good candidates for surgery."

The MitraClip(R) system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of MR in Europe. The MitraClip(R) system is currently in late stage clinical trials in the United States.

About mitral regurgitation

MR is the most common type of heart valve insufficiency in the United States and Europe, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe. There are more than 600,000 new diagnoses of significant MR each year in the US and Europe; however, only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

About the MitraClip(R) Procedure

Mitral repair with Evalve's MitraClip(R) 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(R) 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.

Cofounded in 1999 by The Foundry and Dr. Fred St. Goar, Evalve, Inc., headquartered in Menlo Park, Calif., and 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 procedure using the MitraClip(R) device, visit www.evalveinc.com. The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada. Enrollment is ongoing in the REALISM study in the US, which allows EVEREST investigators and their patients continued access to the MitraClip(R) therapy during the PMA phase. The MitraClip(R) system is commercially distributed in Europe.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.


Source: Evalve

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