Genesis MedTech has announced the completion of enrollment for its early feasibility study (EFS) in the US, evaluating the J-Valve TF System for patients with severe aortic regurgitation (AR).
The J-Valve TF System is designed for a minimally invasive transfemoral approach, eliminating the need for an open-heart procedure.
It is intended to address the unmet needs of patients suffering from aortic valve regurgitation in the US.
Approved by the US Food and Drug Administration (FDA), the EFS trial enrolled patients at five US centres, focusing on symptomatic individuals with severe aortic regurgitation.
The last participant was enrolled at MedStar Washington Hospital Center by Drs Ron Waksman and Lowell Satler.
Co-principal investigators of the study were Dr Dean Kereiakes from the Christ Hospital Heart and Vascular Institute and Dr Michael Reardon from Houston Methodist Hospital.
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Patients who met the inclusion criteria were treated with the J-Valve TF system. The outcomes from this clinical experience are expected to be presented later in the year.
Developed by Genesis’ subsidiary JC Medical, the J-Valve TF System has received breakthrough device designation for treating severe native aortic regurgitation and AR-dominant mixed aortic valve disease.
Currently, the J-Valve TF System is an investigational device in the US and Canada.
Reardon said: “TAVR has proven results for patients with Aortic Stenosis. An unmet need remains for patients with Aortic Regurgitation.
“The J-Valve being a dedicated TAVR design has shown promise in treating patients with aortic regurgitation. We are pleased with our findings to date from our EFS and look forward to the successful initiation of the pivotal trial.”
In October 2023, Genesis MedTech started enrolment for an early feasibility study using its J-TF system in North America.