Halifax Health Performs First Procedure in East Central Florida Using Evolut™ FX+ TAVR System for Patients With Symptomatic Severe Aortic Stenosis

Daytona Beach, FL – (June 19, 2024) Halifax Health treated its first patient using the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system, a minimally invasive alternative to open-heart surgical aortic valve replacement. Halifax Health is among the first in the East Central Florida area to provide this new TAVR system, which further refines the trusted Evolut TAVR platform, designed to facilitate coronary access, for the treatment of severe aortic stenosis (ssAS)1. The procedure was performed by the Structural Heart Team, Sohit Khanna, MD and Vincent Peterson, DO.

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. The disease can impact quality of life and limit one’s ability to participate in daily activities. If left untreated, 50% of patients with aaAS can die from heart failure in as little as two years.     

The newest iteration of the Evolut TAVR system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system. The Evolut FX+ system provides increased space designed for catheter maneuverability to facilitate access to the coronary arteries of varying patient anatomies. Additionally, the new design maintains the valve performance, excellent hemodynamics, and radial strength that clinicians expect from the Evolut platform.

The U.S. Food and Drug Administration (FDA) recently approved the Evolut FX+ TAVR system, providing physicians at Halifax Health with another option to treat the growing ssAS patient population.

"It is encouraging to see how the Evolut FX TAVR platform has evolved considerably over time and brought our heart team another treatment option. With this FDA approval of the Evolut FX+ TAVR system, a system we already trust is now designed to facilitate coronary access while maintaining the performance and durability the Evolut TAVR platform is known for," said, Vincent Peterson, DO and Halifax Health - Cardiology Department Chair.  

For more information about the Evolut FX+ TAVR system, visit Transcatheter Aortic Valve Replacement | Halifax Health.

TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker.

About Halifax Health:

Recognized as one of the 50 Top Cardiovascular Hospitals™ in the United States by IBM Watson Health™, Halifax Health serves Volusia and Flagler counties, providing a continuum of health care services through a network of organizations including a tertiary hospital, two community hospitals, an urgent care network, psychiatric services, a cancer treatment center with five outreach locations, the area’s largest hospice, a center for inpatient rehabilitation, outpatient rehabilitation clinics, primary care walk-in clinics, a clinic specializing in women’s health, a pediatric care community organization. Halifax Health offers the area’s only Level II Trauma Center, Center for Transplant Services, Pediatric Intensive Care Unit, Pediatric Emergency Department with board-certified pediatricians on staff 24/7, Child and Adolescent Behavioral Services, OB Emergency Department and Level III Neonatal Intensive Care Unit that cares for babies born earlier than 28 weeks. It’s also the area’s longest-standing Thrombectomy-Capable Stroke Center (TSC) offering complete stroke care.

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1 Medtronic data on file compared to the Evolut FX/PRO+ platform. Bench top model may not be indicative of clinical performance. Evolut FX+ Test Report: DO1106198 Rev. A

2 Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67.