Jersey Shore University Medical Center Performs First Procedure in N.J. Using Next-Generation EvolutTM FX System in Patient with Symptomatic Severe Aortic Stenosis

September 21, 2022

Illustration of the Evolute FX Transcatheter Aortic Valve Replacement system being deployed in the heart.
Illustration of the Evolute FX Transcatheter Aortic Valve Replacement system being deployed in the heart.

Hackensack Meridian Jersey Shore University Medical Center announced today that it has treated its first patient using the next-generation, self-expanding Evolut™ FX Transcatheter Aortic Valve Replacement (TAVR) System, a minimally invasive alternative to open-heart surgical aortic valve replacement.

The academic medical center is among the first in the nation and the first in New Jersey to provide this fourth-generation TAVR system, which further refines the trusted Evolut platform with key enhancements to the self-expanding system. The first procedure at Jersey Shore University Medical Center (JSUMC) was performed by an expert heart team led by Matthew Saybolt, M.D., FACC, medical director, Structural Heart Disease Program, JSUMC.

The U.S. Food and Drug Administration recently approved the Evolut FX TAVR system, providing physicians at JSUMC another option to treat the growing symptomatic severe aortic stenosis (ssAS) patient population.

“This new TAVR delivery system is directed through blood vessels and into the heart with more flexibility, and our hope is that this new design makes the procedure safer and accessible to more patients. The new system also allows for more precise implantation and is more easily visible through our imaging, enhancing our ability to successfully place the valve in the optimal position for the patient,” said Dr. Saybolt.

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Severe aortic stenosis often reduces a patient’s quality of life and limits their daily activities. If left untreated, patients with severe symptomatic AS can die from heart failure in as little as two years.

For more than 10 years, Jersey Shore University Medical Center has been a leader in New Jersey in performing diagnostic and interventional cardiac procedures. “With the expertise of our physicians, nurses and other clinicians and the innovative heart care technology we provide, like this new TAVR system, Jersey Shore is among the best hospitals for cardiovascular treatment in New Jersey,” said Vito Buccellato, MPA, LNHA, president and chief hospital executive, Jersey Shore University Medical Center.

The newest iteration of the Evolut system is equipped with gold markers built into the frame to provide implanters with direct visualization to better assess depth of implant and valve leaflet location. The FX delivery catheter incorporates a redesigned tip for a smoother insertion profile, and a more flexible delivery system to allow for 360-degree freedom of motion – this helps provide a stable, predictable deployment. The self-expanding Evolut FX TAVR System enables physicians to treat a broad range of patients with varying valve anatomies and includes four key valve sizes for the largest indicated patient annulus range and the lowest delivery profile on the market (for 26-29mm sizes).

“We continue to provide our academic medical center experts with the tools they need to provide innovative, safe and exemplary care to all our patients, the Evolut system is a prime example of our commitment,” said Kenneth N. Sable, M.D., MBA, FACEP, regional president, Southern Market, Hackensack Meridian Health.

In 2021, JSUMC launched a $45 million, invasive cardiovascular technology and suite expansion project. For information about Jersey Shore University Medical Center’s cardiovascular services, visit www.hackensackmeridianhealth.org/en/Services/Heart-Care. For a free physician referral, call 844-HMH-WELL.

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