The treatment of diseased heart valves continues to get more-and-more exciting as new technologies continue to shape the way that valvular disorders are corrected. In the minimally invasive space, Edwards Lifesciences, the largest heart valve replacement manufacturer on the planet, just received a CE Mark for its SAPIEN pulmonic transcatheter heart valve device (shown below).
As you may know, this device was designed as an alternative to surgical valve replacement for patients suffering from congenital heart disease of the pulmonary valve.
This device utilizes Edwards Lifesciences’ transcatheter valve technology — which has already been used in more than 5,000 cases worldwide. Interesting details of the Edwards SAPIEN pulmonic transcatheter heart valve include:
- The valve is a tri-leaflet design;
- The material used is bovine pericardial tissue (from a cow);
- The valve frame is constructed of stainless steel; and
- Prior to delivery, the tissue valve is compressed onto a balloon to the diameter of a pencil. It is then threaded into position, using a delivery system.
Sapien Heart Valve Replacement Device
In the United States, the Sapien Pulmonary Valve Replacement is an investigation device. It is currently being evaluated in the COMPASSION (COngenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) clinical trial.
Also… Edwards recently announced clinical findings for Sapien’s use in aortic valve replacement procedures across 32 medical centers in Europe where the device is commercially available:
- Patients treated with the artery approach had a 81.1% one-year survival rate
- Patients treated with the between-the-ribs approach had a lower 72.1% one-year survival rate.
Yes, this data suggests that several patients died within a year of treatment. However, it is critical to remember that these patients were “high-risk” and often too sick to withstand the rigors of regular chest-opening surgery.
“The encouraging outcomes add to the evolving body of clinical evidence that demonstrates transcatheter aortic valve implantation is a viable option for this high-risk patient population. The data provide valuable, real world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open-heart surgery,” said Dr. Thomas, director of cardiothoracic services, Guys and St. Thomas’ NHS Foundation Trust in London.
Mike Mussallem – Edwards’ Chief Executive Officer
On the outlook for transcatheter devices, Mike Mussallem, the chief executive officer of Edwards Lifesciences, noted in a recent interview, “[Sapien] has not only big growth potential, but potentially changes the landscape for a very long time.”
Specific to that landscape, it definitely feels as if we are on the cusp of some form of transcather transformation specific to heart valve treatment. While there remains no long-term data on the durability of these devices, it is appropriate to acknowledge that these technologies from Edwards, Abbott Laboratories and Medtronic may initially help a select portion of the patient population suffering from heart valve disease (e.g. aortic stenosis, mitral regurgitation).
That said, I recently had the unique and fortunate opportunity to (i) interview a transcathether valve repair patient and (ii) observe a transcatheter procedure. In the next few days, I will be sharing those experiences with you.
Keep on tickin!
