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PinnacleHealth Implants Aortic Valve To First Patients In United States After FDA Approval For Commercial Use

This week, PinnacleHealth became the first hospital in the country to implant the EDWARDS INTUITY Elite valve, a rapid deployment device for surgical aortic valve replacement, after U.S. Food and Drug Administration (FDA) approval.

The team, led by Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of the structural heart program at PinnacleHealth, replaced the aortic valve in two patients using a technique called intercostal surgical aortic valve replacement (iSAVR). This minimally invasive approach accesses the heart through the rib space without dividing any major muscle groups, rib or cartilage. The EDWARDS INTUITY Elite valve system facilitates this approach, which was developed at PinnacleHealth.

“We are able to offer our patients with aortic stenosis less invasive surgical options such as iSAVR. This can mean less trauma, quicker recovery and decreased need for blood transfusions,” states Dr. Mumtaz.

The EDWARDS INTUITY Elite valve system is designed to facilitate and streamline complex aortic valve replacements, thereby offering a cutting-edge treatment option for patients with aortic valve disease.

PinnacleHealth was among the top enrollers in the U.S. in TRANSFORM clinical trial, which evaluated the safety and efficacy of the EDWARDS INTUITY valve system. The FDA recently approved the INTUITY valve due to its positive clinical performance. Results showed that, at one year, the valve system was highly effective and may reduce cross-clamp time and cardiopulmonary bypass time, compared to times recorded in the Society of Thoracic Surgeons’ (STS) Adult Cardiac Database. This may provide patient benefits such as decreased mortality and morbidity, less time in an intensive care unit and reduced total hospital stay.

“Participation in clinical trials can lead to improved care and innovations, particularly for our complex cardiac patients,” states Dr. Mumtaz. “This milestone in cardiac treatment can reassure the community that nationally recognized heart care is available close to home.”

According to an article published in the Journal of the American College of Cardiology, aortic stenosis (AS) is the most common valvular heart disease in developed countries with prevalence estimated between 3 and 23 percent.1 Aortic stenosis mainly affects older people, due to scarring and calcium buildup in the valve cusp. With a growing elderly population, aortic stenosis is anticipated to become a major public health concern.

PinnacleHealth CardioVascular Institute surgeons perform more coronary artery bypassand valve surgeries than any other hospital in the region and is in the top five acute care hospitals in Pennsylvania. While maintaining this high volume, important quality indicators such as mortality and readmission rates remain low,” states Michael A. Young, president and CEO for PinnacleHealth.