News | September 16, 2009

Ongoing Progress of MitraClip Therapy Highlighted at TCT 2009

The MitraClip transcatheter mitral valve repair device being deployed.

September 15, 2009 – EVEREST registry clinical results of the MitraClip therapy for patients with mitral regurgitation (MR) will be a big topic of discussion at the Transcatheter Cardiovascular Therapeutics (TCT) Conference Sept. 21-25 in San Francisco.

MR is the most common type of heart valve insufficiency in the United States and Europe, and affects millions of people worldwide. The MitraClip therapy provides a nonsurgical treatment option for patients suffering from the effects of functional or degenerative MR.

Among oral presentations at TCT 2009, EVEREST investigators as well as independent physicians will report data related to the clinical impact of reduction of MR and the histopathology of the MitraClip device collected as part of the EVEREST registry studies. The data are from the preliminary cohort of the first 107 patients as well as from patients enrolled in the high-risk registry. Other presentations at TCT 2009 will discuss the EVEREST study design, procedure simulation and clinical outcomes of patients treated in Europe following CE mark.

Highlights of the data to be presented at TCT 2009 include:

Tuesday, Sept. 22

• “Successful MitraClip Therapy Results in Favorable Sept-Lateral Mitral Annular Diameter and Left Ventricular Remodeling," Saibal Kar, M.D., will present 12-month results of functional MR patients from the EVEREST II High Risk Registry arm on Tuesday at 10:15 a.m. in room 113.

• “Long-Term Histologic Response Following MitraClip Implantation," Renu Virmani, M.D., will present data on the healing response in patients from the EVEREST I and EVEREST II trials from 301 to 1,878 days after treatment, at 11:15 a.m. in room 113.

• “Significant Reverse Left Ventricular Remodeling One Year After Successful MitraClip Therapy," Scott Lim, M.D., will present 12-month data reporting reverse remodeling in patients from the initial EVEREST patient cohort, at 11 a.m. in room 113.

• "Mitral Regurgitation: Percutaneous Edge-to-Edge Evalve MitraClip System Session," several presentations about the MitraClip therapy will take place from 4:47-6:30 p.m. in room 135.

Thursday, Sept. 24

• An overview of a MitraClip procedure will be presented by Dr. Lim at 2:30 p.m. in the main arena. During the same session Marty Leon, M.D. will demonstrate the MitraClip Virtual Procedure, a unique computer-based procedure simulation system under development.

Evalve said its European Commercial Pace Continues to Grow, with more than 200 so far treated with the MitraClip system. The MitraClip system is the only medical device commercially available in Europe to provide a nonsurgical treatment option for patients suffering from the effects of functional or degenerative MR. As of today patients have been treated with the MitraClip system at 19 institutions throughout Europe.

Evalve initiated commercial sales of the MitraClip system in Europe under the CE mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs to cardiologists and cardiac surgeons in preparation for the first series of implants.

Additional U.S. Clinical Trial Milestone Reached

Evalve also announced today that the last U.S. patient treated in the EVEREST II randomized study has reached the required 12-month follow up. Clinical results from the study are not yet available and will be released in 2010.

Meanwhile, enrollment in REALISM, the continued access registry, continues to be strong with 120 patients treated as of Sept. 1.

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.

Evalve in the process of being acquired by Abbott Vascular.

For more information: www.evalveinc.com

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