St. Francis Hospital First on Long Island to Treat Patient in Landmark Transcatheter Mitral Valve Replacement (TMVR) Trial
Global APOLLO Trial Underway at St. Francis with the Intrepid™ TMVR System for Patients with Severe Mitral Regurgitation
ROSLYN, NY – May 10, 2018 – St. Francis Hospital today announced it is the first on Long Island to treat a patient in the APOLLO Trial – the pivotal trial designed to evaluate the Medtronic Intrepid™ TMVR system in patients with severe, symptomatic mitral valve regurgitation. As the first-ever pivotal trial for transcatheter mitral valve replacement therapy, the study will evaluate the safety and efficacy of the Intrepid TMVR system in up to 1,200 patients globally.
The first patient treated at St. Francis, 90-year-old Archie “Ace” Dalton was implanted by a team led by Drs. George Petrossian and Newell Robinson, Co-Directors of the John Brancaccio Heart Valve Center. (Pictured with Dalton and members of the St. Francis nursing team.)
“Severe mitral valve regurgitation is one of the leading causes of heart valve disease. To be able to offer patients a minimally invasive option for treating it could be a major milestone if this study is successful,” said the St. Francis physicians.
Mitral regurgitation occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, mitral regurgitation can lead to heart failure or death. Because of the complexity of the mitral valve anatomic structure and multiple comorbidities typically present in such patients, the development of less invasive/transcatheter mitral valve therapies has been challenging.
The Intrepid TMVR system’s integrated metallic self-expanding technology facilitates a catheter-based implantation. The Intrepid valve is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve. The outer frame is designed to attach and conform to the native valve without the need for additional sutures, tethers, or anchors to secure the prosthesis. The inner metallic frame houses the valve, which is made from cow tissue and is intended to maintain blood flow.
The APOLLO Trial will enroll patients who are high risk for conventional mitral valve replacement or patients who cannot have traditional surgical mitral valve replacement. The efficacy and safety of the valve procedure will be evaluated as well as the impact on the quality of life and the performance of the valve.
The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical studies.
Contact: Paul Barry, 516-563-7970, firstname.lastname@example.org
Rosemary Gomez, 516-563-7965, email@example.com