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Compliance In Focus
Posted by John Lehmann on Wed, May 8, 2019

What’s New With Transcatheter Mitral Valve Replacement?

Recent advancements in transcatheter mitral valve replacement may make heart surgery less invasive, improving outcomes and reducing recovery time for patients.

This approach has the potential to save lives while reducing recovery time and readmissions. Here’s a closer look at how new medical devices could transform transcatheter mitral valve replacement (TMVR) and why these advancements are so exciting for both patients and medical professionals.



What Is Transcatheter Mitral Valve Replacement (TMVR)?

Transcatheter mitral valve replacement is a procedure to treat mitral regurgitation, which is when blood flows backward through the mitral heart valve each time the left ventricle closes. This can increase blood pressure and results in fluid build-up in the lungs.

Mitral regurgitation affects nearly 1 in 10 people who are 75 years or older, according to an article from the American Heart Association’s journal Circulation. While the symptoms of high blood pressure and fluid accumulation can be treated with medication, surgery is needed to repair or replace the mitral valve.

Transcatheter mitral valve repair or replacement is a less invasive alternative to open-heart surgery.

In transcatheter valve implantation, a replacement valve is inserted by making a small incision under the left breast (transapical) or through the groin (transfemoral).

Surgeons can either repair the valve by reconnecting the valve leaflets and tightening or reinforcing the ring around the valve, using a clip to reshape the valve or replacing the valve entirely.

What Medical Devices Are Approved For TMVR?

Abbott was the first medical device company to earn premarket approval for its TMVR device, MitraClip. The device clips the leaflets around the valve together, preventing backflow and allowing the heart to pump more efficiently. It has treated more than 80,000 patients worldwide, according to Abbott’s news release, and the FDA recently approved the device for secondary mitral regurgitation treatment.

Since then, several other companies have introduced devices. Edwards Lifesciences and Medtronic are also expected to have a significant market share in the coming years, according to an analysis in Cardiovascular Business.

Clinical studies on TMVR systems have been limited, but several have shown promising results. For instance:

  • In Abbott’s study of 614 patients with advanced heart failure and secondary mitral regurgitation, the MitraClip reduced hospitalization in heart failure patients through two years compared to medical therapy alone, from 68 percent to 36 percent. They also experienced fewer all-cause deaths compared to patients in the control group (29 percent compared to 46 percent). Nearly 97 percent of patients had no device-related complications.
  • In a year-long study on 10 patients beginning in August 2017, surgeons successfully implanted a transcatheter mitral valve replacement (TMVR) system in 9 out of 10 patients. All nine patients experienced a significant reduction in mitral regurgitation. The median hospital stay was less than two days, and none of the patients experienced stroke, myocardial infarction, rehospitalization or other serious adverse events. One patient had a paravalvular leak, which was treated with a closure device.
  • A 2018 study on 12 patients resulted in successful implantation of a self-expanding transcatheter heart valve, with adequate function of the prosthetic mitral valve and no serious adverse events.

Market Outlook for TMVR

The global market for transcatheter treatment of the mitral and aortic valves is expected to double over the next five years, from $4 billion in 2018 to $8 billion in 2023, according to a recent report from BCC Research.

However, these procedures still carry significant challenges. There are concerns about the high costs and long-term durability of artificial heart valves, as well as a lengthy process for regulatory approval.

Because the patients who are candidates for these devices tend to be older and at a higher risk, many companies are struggling to obtain approval for clinical trials and achieve statistically significant data, according to BCC Research analyst Ritu Thakur Dangi.

However, if researchers can overcome these challenges, the potential to help high-risk patients is great. Transcatheter aortic or mitral valve procedures are promising alternatives for patients who would otherwise need open-heart surgery.

IMARC has extensive cardiovascular experience ranging from large, complex, multi-national studies, to single center investigator-initiated IDEs. Our experience has included implantable devices, imaging studies, and IVD studies focused on the various stages of cardiovascular disease. Covering such therapeutic areas as thoracic and abdominal aortic aneurysms, peripheral vascular disease, coronary artery disease, heart failure, ischemic cardiomyopathy, and arrhythmias, among others, IMARC is well-versed in the disease process as well as the regulatory framework within which researchers developing these novel treatments must work.

We can assist with every stage of your clinical trial, from developing risk-based study plans to collecting and analyzing study data.

Contact us today to learn more about how we can help you ensure compliance and bring your device to market.

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Topics: Cardiovascular Clinical Trials


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