Newswise — TOLEDO, Ohio, November 18, 2014 – Chest pain, fatigue and shortness of breath are just a few of the symptoms of aortic stenosis or narrowing of the aortic valve in the heart. Worldwide approximately 300,000 people suffer from the condition, which restricts blood flow to the body.
In October, ProMedica Toledo Hospital performed the nation’s first patient implant in the Medtronic, Inc. PERIGON (PERIcardial SurGical AOrtic Valve ReplacemeNt) Pivotal Trial. This global, prospective clinical trial evaluates an investigational surgical aortic heart valve made from bovine pericardial (cow heart) tissue that is intended to replace a diseased, damaged or malfunctioning native or prosthetic aortic valve.
“Aortic stenosis can lead to life-threatening heart problems such as heart failure, an irregular heart beat or cardiac arrest,” said Michael Moront, MD, FACS, cardiovascular surgeon at ProMedica Toledo Hospital. “I’m thrilled to be the first physician in the U.S. to implant this innovative pericardial heart valve, which may offer important advantages critical to long-term patient outcomes.”
The new aortic valve is being evaluated in the trial for its ease of implantation, durability and hemodynamic performance (blood flow). In addition to replacing a diseased native aortic valve, the next-generation valve also is designed to allow for future transcatheter aortic valve-in-valve interventions.
The investigational surgical aortic heart valve currently is only available for investigational use in the United States. The PERIGON Trial will study up to 650 patients at up to 40 sites in Europe, the U.S. and Canada.
For more information about ProMedica Heart and Vascular Institutes, visit www.promedica.org/heart.
About ProMedicaToledo, Ohio-based ProMedica is a mission-based, not-for-profit healthcare organization formed in 1986. ProMedica has more than 15,000 employees and nearly 1,900 physicians with more than 600 healthcare providers employed by ProMedica Physicians. Its 12 hospitals and more than 300 facilities offer comprehensive diagnostic, medical and surgical specialties in heart and vascular, oncology, orthopaedics, neurology, and women and pediatric services. ProMedica’s mission is to improve health and well-being, with a strong focus on wellness and clinical excellence, as well as innovative, community advocacy programs that address health-related issues such as hunger and obesity. For more information, please visit www.promedica.org.
About MedtronicMedtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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