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Mitral valve disease or Mitral Regurgitation (MR) is a prevalent and progressive disease effecting the mitral valve. Nearly 1 in 10 people aged 75 and older has moderate or severe MR. MR is a progressive disease with a typical cascade of events resulting in advanced stages of MR, heart failure and eventually death. There are two types of MR: Degenerative MR, also called primary MR, is caused by damage to the mitral valve itself. It can be related to age, a birth defect, or underlying heart disease. Functional MR, also called secondary MR, is caused by enlargement of the heart (sometimes due to heart attack or heart failure), which in turn prohibits the native valve from adequately sealing the mitral orifice. Symptoms of MR are those typical of heart failure: fatigue, dyspnea, orthopnea and edema and feelings of heart palpitations.

Mitral Valve

The heart has four valves, each of which normally allows blood flow in only one direction through and out of the heart or between the chambers of the heart. The mitral valve lies between the left atrium and the left ventricle which is responsible for pumping oxygenated blood to tissues all over the body.
In normal conditions, the mitral valve opens when the left atrium contracts, allowing blood to flow from the left atrium down into the left ventricle, and from there through the aorta to the body. The mitral valve closes with contraction of the left ventricle, allowing for an efficient outflow from the ventricle and preventing backflow to the atrium.
In abnormal conditions, the valve may become diseased, and blood may flow backward through the mitral valve, causing regurgitation of the blood flow through the valve (mitral valve regurgitation).

What is Mitral Valve Disease

Mitral valve disease or Mitral Regurgitation (MR) is a prevalent and progressive disease effecting the mitral valve. Nearly 1 in 10 people aged 75 and older has moderate or severe MR. MR is a progressive disease with a typical cascade of events resulting in advanced stages of MR, heart failure and eventually death.
There are two types of MR: Degenerative MR, also called primary MR, is caused by damage to the mitral valve itself. It can be related to age, a birth defect, or underlying heart disease. Functional MR, also called secondary MR, is caused by enlargement of the heart (sometimes due to heart attack or heart failure), which in turn prohibits the native valve from adequately sealing the mitral orifice. Symptoms of MR are those typical of heart failure: fatigue, dyspnea, orthopnea and edema and feelings of heart palpitations.

What is Mitral Valve Replacement

There are several causes of valvular heart disease, including congenital conditions, infections, degenerative conditions, and conditions linked to other types of heart disease. Transcatheter therapies are minimally invasive techniques that allow the physician to repair or treat the heart, or areas surrounding the heart. As a minimally invasive technique, which does not involve open heart surgery, it may help patients at high risk of morbidity and mortality with open heart surgery. The “Gold standard” therapy for MR is surgical replacement or repair of the mitral valve. For people who cannot undergo surgery, transcatheter mitral valve replacement (TMVR) provides a newer, minimally invasive option for treating the most common form of mitral valve leakage. Currently there is no pharmaceutical or other non-invasive effective therapy for MR.

JOIN THE
TWIST
CLINICAL
TRIAL

The TWIST Trial is recruiting patients with moderate-severe Mitral Valve Regurgitation and at high risk for surgery.

Twist Clinical Trial

About the TWIST Trial

The objective of the TWIST Trial is to evaluate the safety and the performance of the Innovalve Innostay System in the treatment of mitral valve regurgitation. Data collected in this clinical Trial will include 30-day safety and performance of the device and delivery system, and long-term clinical follow-up over a 5-year period.

Who can join the TWIST Trial?

The TWIST Trial is recruiting patients with symptomatic moderate-severe mitral valve regurgitation, who are at high risk for open heart surgery for the replacement or repair of the mitral valve. You may contact the participating sites directly for additional information.

Innovalve’s Transseptal Mitral Valve Replacement System

The Device under investigation, Innovalve’s Transseptal Mitral Valve Replacement System, is an implantable artificial mitral valve replacement device, meaning that once implanted it will be in the same location as your native mitral valve and function in its place. This new mitral valve is inserted percutaneously, where a small incision is made in your skin into your vein where a catheter (tube) is pushed up to your heart. This catheter is pushed across the wall in the middle of your heart and is positioned in front of your mitral valve and implanted in the correct location.

JOIN THE
TWIST
CLINICAL
TRIAL

The TWIST Trial is recruiting patients with moderate-severe Mitral Valve Regurgitation and at high risk for surgery.

innovalve med

Participating Sites

ISRAEL SITES

USA SITES