Tricuspid Flow Optimizer, FDA Approved, 6 months follow up of the First-in-Man Implantation in Rome, Italy
Reporter: Aviva Lev-Ari, PhD, RN
Tricuspid Flow Optimizer graphic courtesy of Triflo Cardiovascular.
TR – Tricuspid Regorgitation
the Tricuspid Flow Optimizer, was developed by Triflo Cardiovascular, a U.S.-based biomedical company founded in 2017 by a team of structural heart specialists.
After using CT and transesophageal echocardiography (TEE) scans to confirm the procedure was feasible, the care team implanted the device. It includes three anchors that are positioned at the tricuspid valve’s commissures. A 37 French steerable catheter was positioned in the patient’s right atrium for the implant, and the device’s positioning was “optimized” before being released. A second TEE scan confirmed the device had been successfully implanted. The patient was discharged after four days of recovery, and a permanent pacemaker was required after three weeks due to slow-rate AFib.
Six months later, the authors reported, reserve remodeling of the right ventricle and a clear improvement in TR were evident, moderate tricuspid regurgitation.
“The minimal interaction with the right cardiac chamber resulted in an easy implantation of the pacemaker; the polymer leaflets and the minimal footprint demonstrated an optimal adaptation to the native anatomy and stability through six months’ follow-up.”
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Original Study:
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