The Heart Hospital Baylor Plano became the first in the nation to treat a patient with the catheter-based SAPIEN 3 heart valve using the transapical approach (through the ribs). This new phase of a clinical trial, also known as Partner II, may offer older patients with inoperable heart valve conditions a second chance at life.
Edwards Lifesciences Corp. created the transcatheter aortic valve replacement (TAVR) treatment option, which can give patients the opportunity to have their valves replaced without open-heart surgery. While a version of this product is approved by the U.S. Food and Drug Administration (FDA), it is the only one approved at this time. Additionally, there is no drug therapy for this type of valve condition.
Prior to the availability of TAVR, patients with high risk heart valve conditions , or determined to be inoperable, often went untreated. At the Heart Hospital Baylor Plano the heart team takes a comprehensive approach to evaluate these high-risk patients to determine the best treatment options. The team offers patients access to early stage TAVR clinical trials, the latest heart valve devices and a physician heart team with more than 10 years' experience in transcatheter valve therapy.
"The Heart Hospital's mission is to offer the latest, cutting-edge treatments to patients and achieve the highest quality outcomes. We're thrilled to be among 25 sites to be awarded an investigational treatment that offers patients a variety of options to replace their heart valve via a catheter-based approach. This Transcatheter Aortic Valve Replacement not only helps to extend a patient's life but, more importantly, it enhances their quality of life. We're excited that Edwards Lifesciences Corp. continues to provide new innovations that allow surgical teams across the globe to expand offerings to high-risk, inoperable patients," said David L. Brown, MD, Director of Interventional Cardiology and Transcatheter Valve Therapy.
Edwards Lifesciences Corp. received conditional approval from the FDA in August to initiate a clinical trial of the SAPIEN 3 device. The trial is evaluating the safety and effectiveness of the valve for the treatment of high-risk and inoperable patients with severe, symptomatic, aortic stenosis. The trial will enroll up to 500 patients to be treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route using a small incision on the side, and the transaortic approach through a small incision in the chest and aorta.
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