Medtronic has received the US Food and Drug Administration (FDA) approval for the early feasibility study (EFS) of the Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation.
The approval follows the receipt of FDA breakthrough device designation for the Intrepid TTVR System, which is currently an investigational device across the world.
Tricuspid regurgitation is estimated to affect over two million patients in the US. The condition is caused when the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber and may lead to eventual heart failure or death.
It is a highly undertreated disease due to the morbidity and mortality related to surgical intervention.
Co-principal investigator of the study and Minneapolis Heart Institute cardiothoracic surgery chief Vinayak Bapat said: “The clinical experience generated during this initial study phase will be critical for the future of the therapy as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to co-morbidities.”
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Medtronic noted that the Intrepid transcatheter valve is also being assessed for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study.
The device is implanted using a transfemoral delivery catheter, which helps physicians to deliver and position the valve through a catheter inserted in the femoral vein.
Earlier this month, the US FDA approved Medtronic’s MiniMed 770G System for use by paediatric patients aged between two and six years with type 1 diabetes.
Last month, the company started the post-market study of the InterStim Micro System for sacral neuromodulation (SNM) therapy to treat overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention (NOUR).