News | March 21, 2007

High Risk Patients Now Eligible for MitraClip in Evalve’s Study

March 22, 2007 — Evalve, Inc., a privately held medical device company, has announced the FDA has approved a registry of up to 70 patients who are at high risk of mortality from surgical treatment for mitral regurgitation (MR) as part of its ongoing pivotal EVEREST Study (Endovascular Valve Edge-to-Edge REpair STudy). Previously, enrollment in the EVEREST study was only available to lower-risk patients recommended for surgery.

"The new registry study allows investigators the ability to offer higher- risk patients a less-invasive option for correcting mitral regurgitation," said Patrick Whitlow, M.D., director of Interventional Cardiology, and EVEREST II Principal Investigator at Cleveland Clinic.

"Many MR patients do not undergo surgery because they have other conditions that put them at significant risk for operative mortality and morbidity. Many of these higher-risk patients have been referred to the EVEREST study, but until now were not eligible to participate," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Hospital in Evanston, IL and EVEREST II Co-Principal Investigator.

An estimated four million people in the United States have significant (3 or 4 ) MR, with an annual incidence of 250,000 newly diagnosed patients. However, only 20 percent of these patients, or approximately 50,000, undergo surgery each year; the other 200,000, which includes the higher-risk patient population, undergo palliative medical therapy.

"Less invasive options are important for the higher-risk patients," said Nicholas Smedira, M.D., director for the Kaufman Center for Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Cleveland Clinic. "Patients not only do better during non-invasive procedures, but they tend to recover quicker."

"Based on promising data to date, particularly with respect to safety, the MitraClip device may be a viable treatment option for these higher-risk patients," said Donald Glower, M.D., professor of cardiovascular surgery, Duke University Medical Center, and Co-Principal Investigator of EVEREST II. "The new registry provides higher-risk patients access to this technology for the first time."

To date, over 160 patients have been treated with a MitraClip device in the EVEREST clinical study. The ongoing randomized study arm of EVEREST II compares the safety and efficacy of the MitraClip device to open arrested heart surgery at over 40 sites in the United States and Canada. Patients are randomized 2:1 to receive the MitraClip device or standard mitral valve surgery.

For more information visit www.evalveinc.com.


Related Content

News | Heart Valve Technology

Aug. 28, 2025 — Medtronic plc has announced it received U.S. Food and Drug Administration (FDA) approval for the ...

Home August 29, 2025
Home
News | Heart Valve Technology

Aug. 18, 2025 — A new study published in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons ...

Home August 19, 2025
Home
News | Heart Valve Technology

Aug. 4, 2025 — Corcym announced that its Perceval Plus sutureless aortic heart valve was used in a first-ever robotic ...

Home August 05, 2025
Home
News | Heart Valve Technology

July 10, 2025 — On July 2, 2025, Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination ...

Home July 11, 2025
Home
News | Heart Valve Technology

June 27, 2025 – Foldax Inc., a leader in the development of innovative polymer heart valves, has announced compelling ...

Home June 27, 2025
Home
News | Heart Valve Technology

June 04, 2025 — HeartSciences Inc. has announced that the U.S. Food and Drug Administration has granted Breakthrough ...

Home June 12, 2025
Home
News | Heart Valve Technology

May 27, 2025 — Abbott has announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne ...

Home May 28, 2025
Home
News | Heart Valve Technology

May 2, 2025 – New analysis from the EARLY TAVR trial showed patients between the age of 65 and 70 years old derived the ...

Home May 02, 2025
Home
News | Heart Valve Technology

April 28, 2025 — The Society of Thoracic Surgeons (STS) has launched its latest surgical risk calculator designed for ...

Home April 29, 2025
Home
News | Heart Valve Technology

March 30, 2025 — Medtronic has announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data ...

Home March 31, 2025
Home
Subscribe Now