News | Heart Valve Technology | August 26, 2016

PinnacleHealth Achieves First U.S. Edwards Intuity Aortic Valve Implants

Pennsylvania health system deployed valve in first two U.S. patients via minimally invasive intercostal surgical aortic valve replacement

Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants

August 26, 2016 — This week, PinnacleHealth, Harrisburg, Pa., 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, M.D., 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,” stated Mumtaz.

The 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 United States in the 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,” stated 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. 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.

For more information: www.edwards.com

Related Content

CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

News | Heart Valve Technology| August 01, 2017
Aug.
Sponsored Content | Videos | Peripheral Artery Disease (PAD)| July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Overlay Init