Adam’s Heart Valve Surgery Blog

Since my heart valve surgery, I have been fascinated by the strategic, corporate acquisitions of leading device manufacturers in this industry.

In fact, I began writing about the ongoing consolidation of heart valve manufacturers years ago. As of late, the “urge-to-merge” has really focused on the minimally invasive technologies for both heart valve repair and heart valve replacement.

That said, it was somewhat expected that a company like Evalve, with its MitraClip technology for mitral regurgitation, would be acquired. However, for some reason, I didn’t think that Abbot Laboratories would be the gobbler. I thought Edwards or Medtronic or St. Jude might be the buyer. (Then again, I think Abbot was one of Evalve’s investors.)

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In case you missed it, there was some pretty big news earlier this week regarding Edwards Lifesciences and their minimally invasive aortic valve replacement technology known as SAPIEN. Here are the details:

Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced completion of enrollment in its 1,040-patient randomized controlled Investigational Device Exemption (IDE) study of the Edwards SAPIEN transcatheter heart valve.

In addition to completing enrollment in both the surgical and non-surgical arms of the PARTNER Trial, Edwards received U.S. Food and Drug Administration (FDA) IDE approval for non-randomized continued access to the Edwards SAPIEN valve for actively enrolling PARTNER sites.

“It’s exciting that the clinical community will soon have the opportunity to make an informed evaluation of this treatment against conventional therapies that may not be realistic options for high-risk patients with severe aortic stenosis,” said Craig Smith, M.D., interim surgeon-in-chief and chief of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center.

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As we have discussed, the competitive market for minimally invasive heart valve replacements and heart valve repair continues to heat up.

Earlier this week, we learned more about Edwards’ SAPIEN technology. Then came this interesting story about Medtronic and its Melody transcatheter pulmonary heart valve replacement solution. Did you see this?

The Associated Press reported that federal health advisers unanimously backed an experimental heart valve replacement solution from Medtronic as a safe and effective treatment for patients with a rare heart defect.

The Melody Heart Valve Replacement

The Food and Drug Administration’s panel of heart experts voted 12 to 0 in favor of approving the Melody Pulmonary Valve, although stent fractures were identified during the study. According to The Wall Street Journal, the FDA said stents - which are a part of the Melody device - fractured in 18% of patients in the study. The concern about such fractures is that parts of the device could break off and result in blood clots. Ultimately, the FDA believes there is a “low probability” that such fragments would cause blood clots.

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Since my own heart valve surgery, writing my book and launching this website, I have developed a huuuuuuuge interest in companies that develop, market and sell heart valve devices and medical equipment.

Ultimately, I believe their actions and announcements illustrate the surgical trends which directly impact patients with heart valve disease. So, for this reason, I constantly monitor companies like Edwards Lifesciences, Medtronic, St. Jude Medical and Intuitive Surgical to learn more about heart valve repair and heart valve replacement technologies. I then pass along that information to you here in this blog.

Earlier this week, Edwards Lifesciences, the largest heart valve replacement manufacturer in the world, released very strong quarterly earnings. However, beyond the financial numbers, the company made several comments about SAPIEN, Edwards’ minimally invasive heart valve replacement technology (see the video above) that I found interesting.

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