Some heart patients are too high-risk to undergo surgery, but in the future there could be a new option for these people, thanks to a mitral valve invention coming out of Cleveland Clinic. When the mitral valve is insufficient (leaking), quality of life suffers deeply—patients have difficulty breathing because the abnormal valve blocks blood flow to the heart. They may be admitted to the ICU for heart failure time and again, with no options other than medical management.
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A novel transcatheter mitral valve system could completely change the story for patients who are not currently eligible for surgery. The concept was developed by José Navia, MD, a surgeon in the Department of Cardiovascular and Thoracic Surgery, and colleagues at Lerner Research Institute (LRI) and Cleveland Clinic Innovations.
“The main purpose for everything we do is to help patients, and as patients with heart failure are getting older and sicker, we were looking for ways to give them options,” Dr. Navia says of the inspiration for his idea.
The Cleveland Clinic Innovations team helped to develop the idea and broaden the concept, which uncovered even greater opportunity than Dr. Navia had initially imagined. Dr. Navia worked with LRI engineers and researchers to design and test prototypes.
How the idea grew
The transcatheter mitral valve delivery started as a simple idea for a ring that would repair a leaky heart valve, eliminating the need for sutures. But the product idea evolved into a new way of performing mitral valve surgery percutaneously (through a catheter). Through the innovation process, it was expanded into a complete system for heart valve replacement.
“This innovation shows how a simple idea can evolve into a platform technology,” says Mary Kander, senior commercialization officer at Cleveland Clinic Innovations. “It takes a comprehensive team of surgeons, researchers and engineers working together to develop a full range of technology.”
Transcatheter Mitral Valve System
How the system works
Here’s how transcatheter mitral valve system works: The valve stent framework, tissue valve and delivery system safely and securely attach the valve to the valve annulus without using sutures. The new stent valve is implanted over the existing valve during a percutaneous procedure. “This is a further evolution of percutaneous valve surgery,” Kander explains.
The road ahead
Currently, mitral valve implantation procedures that can be performed percutaneously are not available to patients. Before procedures using the device developed by Dr. Navia and his team can be implemented, lots of studies and further scrutiny take place.
After testing, gaining patents (some still pending) and approaching medical companies to gather their insight and interest in the project, the transcatheter mitral valve system was licensed to NaviGate Cardiac Systems, Inc., and the Clinic continues to collaborate with the firm on further development and studies.
“Once animal studies proves the safety and effectiveness of this device, we can begin use in people. In a year, we’d like to be doing the first human procedure in Europe,” Dr. Navia says, noting that NaviGate is simultaneously seeking approval overseas and in the United States.
The transcatheter aortic valve system (TAVR) has provided treatment to many patients who are not candidates for aortic valve surgery. Patients with mitral valve disease are hoping that in the future this will be an option for them. Dr. Navia is working on answers for these patients.
Learn more about percutaneous interventions for valve disease
Learn more about heart failure
Learn more about mitral valve repair