The Foundry Announces Successful First-In-Human Procedure In Study Of Innovative Transcatheter Mitral Valve Repair Technology

Rhea-AI Summary

The Foundry has successfully completed the first-in-human procedure using the Half Moon Medical transcatheter mitral valve repair technology at Oregon Health and Science University as part of an FDA-approved feasibility study. The device addresses severe symptomatic mitral regurgitation, a common heart valve disease affecting approximately four million people in the U.S. The first patient has been discharged and is recovering as anticipated. This innovative solution offers a minimally invasive alternative to traditional open-heart surgery, providing a significant advancement in heart valve repair.

Positive

• Successful first-in-human procedure demonstrates the viability of the Half Moon mitral valve repair device.
• The device addresses a significant medical need, serving approximately four million patients in the U.S. with mitral regurgitation.

Negative

• None.

MENLO PARK, Calif., Jan. 11, 2021 /PRNewswire/ -- The Foundry today announced the successful completion of the first-in-human procedure with the Half Moon Medical transcatheter mitral repair technology (TMVr) at Oregon Health and Science University (OHSU) as part of an FDA-approved early feasibility study. The first patient treated has been discharged from the hospital and is recovering as expected.

The investigational Half Moon mitral valve repair device, developed through a unique partnership between Medtronic (NYSE:MDT) and The Foundry, is designed to restore function in a diseased mitral valve in patients with severe symptomatic mitral regurgitation (MR), a disease where blood leaks backwards within the heart due to the mitral valve's inability to close properly.

"We are pleased to be able to offer our patients new options for heart valve repair as early as possible through studies such as this," said Firas Zahr, M.D., OHSU interventional cardiology director, who co-led the procedure.

"Minimally invasive transcatheter heart valve repair can offer relief from mitral valve regurgitation without the need for traditional open-heart surgery," said Howard Song, M.D., Ph.D., OHSU cardiothoracic surgery division chief, who co-led the procedure. Scott Chadderdon, M.D., OHSU Knight Cardiovascular Institute clinical trials director, also led echocardiography to guide the procedure.

The Half Moon mitral valve repair device is unique from other mitral valve repair technologies in maintaining more natural physiologic functionality of the mitral valve. It is deployed using a transfemoral (through the leg) delivery catheter, which is navigated through the vasculature to the diseased native mitral valve. The device is fully repositionable and recoverable during deployment and preserves options for patients who may need re-intervention in the future.

"This technology is a truly innovative solution designed to eliminate regurgitation by restoring physiologic coaptation of the native mitral valve," said Matt McLean, Co-Founder and Chief Operating Officer at Half Moon Medical, the sixteenth Foundry company, founded in 2017. "On behalf of the entire team at Half Moon, I would like to congratulate the team at OHSU on this incredible achievement."

Mitral regurgitation is the most common heart valve disease in the US, affecting an estimated four million people. If left untreated, MR may lead to chronic heart failure, the leading cause of hospitalization in the U.S. and Europe.

About The Foundry
The Foundry was founded in 1998 to rapidly translate concepts into successful new medical device companies. In addition to inventing new technologies itself, The Foundry works closely with outside inventors with promising ideas. Over the past 22 years, The Foundry has formed over 22 new companies, including Evalve (Abbott- MitraClip) and Twelve (Medtronic- Intrepid) in the structural heart space. Other companies include Concentric Medical (acquired by Stryker), Emphasys (acquired by Pulmonx), Ardian (acquired by Medtronic), and incubator Forsight Labs, which has created several successful ophthalmic companies. The Foundry, LLC is located in Menlo Park, California. For more information, visit the company's website at www.thefoundry.com.

Contacts:

Katy Frame
(610)-613-3549                                                                       
kframe@brgcommunications.com

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SOURCE The Foundry

FAQ

What is the Half Moon mitral valve repair technology?

The Half Moon mitral valve repair technology is a transcatheter device designed to restore function in patients with severe symptomatic mitral regurgitation, allowing for a minimally invasive treatment option.

When was the first-in-human procedure for the Half Moon device completed?

The first-in-human procedure with the Half Moon device was completed on January 11, 2021.

Where was the first procedure of the Half Moon device performed?

The first procedure of the Half Moon device was performed at Oregon Health and Science University.

What are the implications of the Half Moon device for patients with mitral regurgitation?

The Half Moon device offers a new minimally invasive treatment option for patients suffering from mitral regurgitation, which, if untreated, may lead to chronic heart failure.

What company is behind the Half Moon mitral valve repair technology?

The Half Moon mitral valve repair technology is developed through a partnership between Medtronic and The Foundry.