University Hospitals Announces First Commercial Implant in the U.S. of the Evolut PRO Transcatheter Heart Valve

June 6, 2017

News Release

Department of Marketing and Communications
3605 Warrensville Center Road
Cleveland, OH 44122

Date May 11, 2017

Contact: Mike Ferrari
216-844-7239
Mike.Ferrari@UHhospitals.org

UH first to offer new generation of the self-expanding, recapturable heart valve

CLEVELAND – New surgical options are only as good as they make you feel once you leave the operating room. One of the biggest post-operative issues with the usually sound transaortic valve replacements (TAVR) was that the newly inserted valve allowed leakage that created poor outcomes.

University Hospitals announced that its surgeons completed the first commercial implant in the United States of the newly FDA approved TAVR valve called the CoreValve™ Evolut™ PRO for the treatment of severe symptomatic aortic stenosis. Recently unveiled clinical data showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve.

The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.

“The fact that the UH structural heart team was elected as the first one in the U.S. to use this new device commercially, definitely reflects our leadership on the field,” said Gui Attizzani, MD, cardiologist and lead interventionalist who performed the maiden procedure. “The new design and flexibility solves a problem created by post-operative leaking in previous generations of valves used in TAVR.”

Built on the proven platform of the recapturable CoreValve Evolut R System, the Evolut PRO valve includes a self-expanding nitinol frame with its supra-annular valve position that helps achieve excellent performance while reducing PVL

The Evolut PRO System provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The 23 mm, 26 mm and 29 mm sizes of the Evolut PRO System are available for use in the United States. It is not available for use in countries outside of the U.S.

TAVR is a nonsurgical procedure performed with local anesthesia in which a special catheter (hollow tube) is threaded into a blood vessel through the groin and guided inside the heart. This procedure enables the implantation of a new heart valve without the need of opening the chest ultimately replacing a severely stenotic (narrow) aortic valve which delivers enhanced and elongated quantity of life for patients.

UH is recognized as a high-volume Center of Excellence and was the first training site for the minimalist, percutaneous conscious sedation TAVR approach for other centers in the U.S. UH Cleveland Medical Center is recognized by the American Heart Association and other agencies for their optimal transcatheter aortic valve replacement practices, as well as internationally, with our physicians teaching this procedure all over the world.

The benefits of lighter sedation, minimal blood loss and cardiac complications are among the benefits to the patients. Additionally, hospital stay is reduced and recovery and rehabilitation is minimized.

Today TAVR is commercially approved by the FDA for moderate or higher surgical risk patients. UH is one of the 45 sites in the US and the only hospital in Cleveland area exploring a clinical trial for expanded indications for transcatheter aortic valve replacement for low surgical risk patients.

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About University Hospitals
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system’s flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland’s University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals – part of The Harrington Project for Discovery & Development. UH is the second largest employer in northern Ohio with 26,000 employees. For more information, go to UHhospitals.org.

 

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