Prof. Gian Paolo Ussia of the Campus Bio-Medico University Rome to present successful 9-month outcomes data at the 2024 New York Valves – The Structural Heart Summit conference
NEWPORT BEACH, CA, June 06, 2024 /24-7PressRelease/ — Triflo Cardiovascular announces that Gian Paolo Ussia of the Fondazione Policlinico Universitario Campus Bio-Medico, Rome, will present the outcomes of the first tricuspid valve regurgitation patients treated with the Company’s Tricuspid Flow Optimizer system. The presentation will be at the 2024 New York Valves – The Structural Heart Summit conference at the Javits Convention Center in New York City. Organized by the Cardiovascular Research Foundation, the conference is the leading global gathering focused on valvular and structural heart disease.
The first patients treated with the Tricuspid Flow Optimizer at the Humanitas University Hospital Milan and the Campus Bio-Medico University Rome were not eligible for any approved therapeutic procedures to reduce their severe regurgitation. The implant procedures were successful and safe. At nine months of follow-up, consistent and marked improvements were sustained in diminishing tricuspid valve regurgitation and right ventricle size and volume while increasing exercise capacity and quality of life. “Following years of development and exhaustive testing, we are thrilled that the Optimizer has performed as intended to benefit the patients in this first-in-human trial” remarked Luca Pesce, CEO of the Company.
Tricuspid valve regurgitation is a condition in which the valve that separates the top and bottom chambers of the right side of the heart fails to close properly leading to backward leakage of blood. When the leakage is severe, the heart muscle works under increasing stress and reduced output, often leading to heart failure, arrhythmias, physical limitations, and increased mortality. Significant tricuspid valve regurgitation affects an estimated 2.4 million people in the US. The efficacy of drugs is marginal, and surgery is rarely performed due to its high risk. Two minimally invasive transcatheter repair and replacement devices have recently been approved in the US, but patient eligibility remains limited. Frank Ahmann, Triflo’s CBO, stated that “wide gaps remain for technologies to address a larger population of tricuspid regurgitation patients, and we expect that the Tricuspid Flow Optimizer will play a significant role in filling those gaps.”
About the Tricuspid Flow Optimizer
Triflo Cardiovascular designed the Tricuspid Flow Optimizer specifically for the tricuspid valve and the right side of the heart. Delivered in a minimally invasive transcatheter procedure, the implant works in tandem with the right atrium, the right ventricle, and the native valve regardless of size or shape to significantly reduce severe regurgitation. Expected benefits include an excellent safety and biocompatibility profile due to its minimalistic design, secure fixation, and an adaptive mini-valve with polymer leaflets. It is an investigational device that is not available for sale.
About Triflo Cardiovascular
Based in Newport Beach, California, USA, privately held Triflo Cardiovascular is a clinical stage startup founded in 2017 to develop safe and effective device therapies for the treatment of tricuspid valve regurgitation and right-side heart failure. For more information, visit www.triflocv.com or Triflo on Linkedin.
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