Mitral Valve Prolapse, Functional MR, Cardiac Surgery, Degenerative MR, and Cardiomyopathy -- Evalve, Inc.

Everest II Clinical Trial for Patients with Mitral Regurgitation

About Evalve, Inc.

Evalve is sponsoring clinical trials in order to secure regulatory approval from the FDA (Food and Drug Administration). Enrollment in the EVEREST (Endovascular Valve Edge-to-Edge REpair STudy) I clinical research study, designed to evaluate the feasibility of the MitraClip^® system, was successfully completed in February of 2006. Enrollment in the EVEREST II clinical research study, designed to evaluate the safety and efficacy (or effectiveness) of the MitraClip^® system, was completed in September of 2008.

The Evalve MitraClip^® System

Overview

The Evalve MitraClip^® system is used by interventional cardiologists and is intended to reduce mitral regurgitation (MR), adapting the open surgical edge-to-edge technique in a less invasive catheter-based procedure.

Edge-to-Edge Technique

Since the early 1990’s, edge-to-edge has been increasingly used in the treatment of mitral regurgitation (MR). Pioneered in Italy by Dr. Ottavio Alfieri, the technique involves suturing together the two leaflets of the mitral valve. On both sides of the suture, the valve continues to open, allowing blood to flow through the valve from the left atrium to left ventricle, while ensuring proper valve closure when blood is pumped from the left ventricle to the rest of the body.

Well over 1,500 procedures have been reported in peer-reviewed clinical literature with up to 15 years of follow-up. The collective experience has demonstrated that the surgical technique appears to be safe, effective and durable.

The Evalve MitraClip^® System

The system consists of three major subsystems:

	A Steerable Guide Catheter,
	A Clip Delivery System, and
	The MitraClip^® Device (implant).

The Guide Catheter is inserted into the femoral vein at the groin and provides access to the mitral valve. The Clip is used to grasp and fasten together the valve leaflets. The Clip Delivery System is used to deliver and deploy the MitraClip^® device.

Patients recovering from mitral valve surgery may take up to several months to regain normal physical function and activity. Because the percutaneous MitraClip^® procedure does not require a chest incision or the use of a heart lung machine, patients may avoid the complications and long recovery time associated with surgery.
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Purpose / Objectives of the EVEREST II Clinical Study

EVEREST II is an ongoing Phase II FDA approved clinical research study to assess the safety and efficacy (or effectiveness) of the MitraClip^® system for patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) MR. Study participants are required to have a number of follow-up visits and evaluations including ultrasound studies over the course of at least a 24-month period following treatment. These follow up visits are intended to monitor the outcome of the procedure. EVEREST II consists of a randomized arm and a High Risk Registry arm.

EVEREST II Randomized Arm

Enrollment in this arm was successfully completed in September 2008. Initiated in 2005, this study arm compares the MitraClip^® procedure to the current standard of care, mitral valve surgery. To ensure unbiased results, participants were randomly assigned to either the MitraClip^® procedure or to surgery, in a "two-to-one" ratio. This means that 2 out of 3 trial participants underwent the MitraClip^® procedure and 1 out of 3 trial participants underwent mitral valve surgery.

EVEREST II High Risk Registry Arm

Enrollment in the High Risk Registry arm was successfully completed in January of 2008. Initiated in 2007, this study arm was designed to evaluate the safety and efficacy of the MitraClip^® system in patients who are considered to have a high risk of not surviving surgery.

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Within the United States: Investigational Device. Limited by United States law to investigational use. Within Canada: Investigational Device. To Be Used by Qualified Investigators Only – Instrument de recherche. Réservé uniquement à l'usage de chercheurs compétents.

This product is available for commercial distribution in the EU.