I'm just getting back from the Heart Valve Summit in Chicago. It's an amazing conference where hundreds of surgeons, cardiologists, nurses and medical device companies gather to discuss the best practices for heart valve management and therapy.

[Please note that Abbott, the manufacturers of the Trifecta GT aortic valve replacement, have stopped making the device due to an FDA warning about structural valve deterioration. To learn more, please click here.]

At the recent Heart Valve Summit, I received several questions about the latest technologies including TAVR, sutureless valves and the MitraClip. I also received questions about the new transcather mitral valve replacement device that is currently in a feasibility study.

The Perceval Sutureless Heart Valve just received a Food & Drug Administration (FDA) approval on January 11, 2016. This was really big news as the Perceval is the first rapid-deployment, sutureless heart valve for patients with aortic stenosis.

[June 3, 2025 Update: The Tendyne device received FDA approval. To learn more, click here.]

Not that long ago, people who underwent heart valve or other cardiovascular surgery had to wait until their next doctor's appointment to monitor their heart health. Granted, you probably could have purchased an at-home blood pressure monitor or visited the local pharmacy... But, that was about the extent of it.

In case you missed the big news last week...

The world's very first heart surgery was said to have taken place only a little more than a century ago. Today, it's almost common place, with millions undergoing surgeries like cardiac catheterizations, coronary artery bypass grafts and valve related procedures.

New heart valve companies don't pop up often. The last time there was an innovation rush in this field was about 10 years ago, when several transcatheter heart valve companies were launched to develop valves delivered to the patient's heart via catheter. Since that time, the Edwards SAPIEN class of products got FDA approval in the United States, and a whole bunch more are being sold in Europe.

Very neat!

Patient interest specific to transcatheter aortic valve implantation is very, very, very high. However, patients with mitral valve disorders, including mitral regurgitation, are wondering, "What about me? Are there any catheter-based solutions for mitral valve surgery?"

The possibility of aortic valve replacement without an incision to the sternum or ribs of the patient has become a reality for select patient categories. Together, our community has followed the evolution of catheter-based technologies including the SAPIEN heart valve replacement by Edwards Lifesciences which received FDA approval for "inoperable" patients last year. Needless to say, patient interest specific to this and other transcatheter devices, including the CoreValve and the MitraClip, is significant.

For those of you monitoring the progress of the transformational Edwards SAPIEN Valve, which replaces the aortic valve in "non-operable" patients, more encouraging data was just released at the American College of Cardiology Conference in Chicago. The SAPIEN is the first catheter-based device, approved by the FDA, that replaces a valve suffering from aortic valve stenosis without any trauma to the patient's sternum or ribs.

Advances in medical technology for valvular treatment continue to evolve rapidly. Recently, I learned more about the use of Extracelluar Matrix (ECM) for heart valve repair and remodeling from Dr. Marc Gerdisch, the chief of cardiothoracic surgery at St. Francis Heart Center in Indianapolis, Indiana. In 2008, Doctor Gerdisch was the world's first surgeon to use ECM to repair a damaged heart valve.

When the latest results of the PARTNER trial became available, many in the medical, investment and patient communities quickly analyzed the data specific to the new SAPIEN heart valve replacement. As you may be aware, the SAPIEN (i) requires no trauma to the sternum during aortic valve replacement, (ii) is currently used for high-risk patients suffering from aortic stenosis, and (iii) has yet to receive FDA approval in the United States.

I'm fascinated by the different tools and technologies that help surgeons reconstruct the human heart.