The J-Valve TF System is intended to address the unmet needs of patients suffering from aortic valve regurgitation in the US. Credit: Natali _ Mis/shutterstock.com.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.