MitraClip(R) Therapy Data Demonstrate Significant Reduction in Mitral Valve Annulus Dimensions in High-Risk Patients With Functional Mitral Regurgitation

SAN FRANCISCO -

- 12-Month Data Also Demonstrate Significant Reduction in Left Ventricular Volumes

Twelve-month data from EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study high-risk registry arm presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco show that high risk patients with functional mitral regurgitation (MR) following valve repair with the MitraClip(R) system showed a reduction in mitral annular dimension, improvement in heart function and a reduction in hospitalization for congestive heart failure.

The data were presented today by Saibal Kar, M.D., director of interventional cardiac research at Cedars-Sinai Medical Center, Los Angeles, CA and the lead enrolling investigator of the EVEREST II trial. The EVEREST II study was designed to evaluate the MitraClip(R) system for the treatment of MR.

This data included 34 patients from the high-risk registry with moderate-to-severe (3+) or severe (4+) functional mitral regurgitation who received a MitraClip(R) device and had matched core laboratory echocardiographic data at baseline and 12 months. Results included a mean MR grade reduction from 3.2+/-0.5 at baseline to 1.8+/-0.9 at 12 months. In addition to the reduction of MR, there was significant reduction in the systolic and diastolic septo-lateral mitral annular diameter as well as a significant reduction in left ventricular end diastolic and systolic volumes. Left ventricular ejection fraction (LV EF) did not change significantly from baseline, while forward stroke volume (FSV) improved, indicating improved cardiac efficiency. Results were as follows:

Baseline and 1 year echocardiographic results

Baseline 1 year p-value ——– —— ——- MR (n=34) 3.2+/-0.5 1.8+/-0.9 <0.0001 -------- ------- ------- ------- Septo-lateral mitral annular diameter (systolic) (cm) (n=33) 3.2 +/- 0.4 3.0 +/- 0.3 0.0072 ------------------------------------- ----------- ----------- ------ Septo-lateral mitral annular diameter (diastolic) (cm) (n=33) 3.8 +/- 0.3 3.6 +/- 0.3 <0.0001 ------------------------------------- ----------- ----------- ------- LV EF (percentage) (n=34) 47 +/- 11 44 +/- 11 NS ------------------------ ------- ------- ---- FSV (ml) (n=33) 51 +/- 13 55 +/- 15 0.06 -------------- ------- ------- ---- LVEDV (ml) (n = 34) 192 +/- 46 153 +/- 44 <0.0001 ------------------ -------- -------- ------- LVESV (ml) (n = 34) 103 +/- 37 87 +/- 35 0.0002 ------------------- -------- ------- ------- LVID-d (cm) (n = 34) 6.0 +/- 0.6 5.6 +/- 0.7 <0.0001 ------------------- --------- --------- ------- LVID-s (cm) (n = 34) 4.5 +/- 0.9 4.3 +/- 0.9 NS ------------------- --------- --------- ----

“We were pleased to see that in addition to a reduction in MR, patients had significant reductions in left ventricle size and mitral annual diameter we believe contributes to an improved quality of life,” said Dr. Kar. “With this therapy, we have been able to expand the options available to selected patients who are at high risk for more invasive treatments, and help them to avoid the risks associated with surgery. We look forward to validating these important findings with ongoing studies.”

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, the majority of which have FMR. 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.

Media Contact: Heather Harper Edelman +1-415-486-3233 office +1-415-533-1001 mobile Heather.Harper@edelman.com

Source: Evalve, Inc.

Heather Harper of Edelman, office, +1-415-486-3233, mobile, +1-415-533-1001, Heather.Harper at edelman.com, for Evalve, Inc.