JenaValve Gets CE Mark For TAVR Device In Europe
Written By: Adam Pick, Patient Advocate, Author & Website Founder
Page Last Updated: May 10, 2025
As many patients in the United States have benefitted from the use transcatheter aortic valve replacement (TAVR) devices for the treatment of aortic stenosis, another TAVR technology received a CE mark for commercial use in Europe for aortic regurgitation.
JenaValve TAVR – Aortic Valve Replacement Via Catheter
JenaValve Technology, a medical device manufacturer in Germany, announced its receipt of a CE mark for its 2nd-generation transapical TAVR system. As you may know, this technological breakthrough is used to treat patients with severe aortic regurgitation who are considered “inoperable” or too “high-risk” for surgery.
Using the JenaValve, a patient’s diseased aortic valve can be replaced without traditional surgical procedures that use incisions to the sternum (sternotomy) or ribs (thoracotomy).
The JenaValve & Its Delivery System
Reflecting upon this announcement, Prof. Dr. Friedrich-Wilhelm Mohr, Medical Director of the Department of Cardiac Surgery at the University of Leipzig Heart Center, noted:
“Now patients have access to a new generation system for transapical TAVR treatment. The JenaValve design allows the cardiac surgeon and cardiologist to achieve precise positioning and allows repositioning of the heart valve prosthesis with its unique, patented positioning feelers. It is with these key features that the system distinguishes itself from its competitors,” — Prof. Mohr.
There are other TAVR devices that are similar to the JenaValve, including the Edwards SAPIEN Valve and the Medtronic Evolut. However, those devices are used to treat aortic stenosis not aortic regurgitation.
Related Links:
- Linda Travels to Germany for New JenaValve TAVR
- Aortic Stenosis and TAVR Patient Education Center
- TAVR Q&A: Top 5 Facts Patients Need to Know
Considering the excitement regarding catheter-based technologies for heart valve treatment, I will continue to monitor this topic. So, stay tuned!
Keep on tickin!
Adam
Written by Adam Pick
- Patient & Website Founder
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elias zaidman says on October 5th, 2011 at 2:16 pm |
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Why is Tavi not recomended for all patients instead of only high risk patients? |
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Doris Taylor-Marcus says on October 5th, 2011 at 4:09 pm |
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How many patients have recived the JenaValve and over what period of time? Is there a study going on in the United States at the present time using this method? |
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Robert says on October 5th, 2011 at 10:40 pm |
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Excuse my ignorance, what is a CE Mark? My concern is that how many surgeons are trained to use the catheter method? And how often usually for such a new technology to be commonly practiced by most top surgeons? Thanks. |
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Jim Hayden says on October 6th, 2011 at 4:32 pm |
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My first bovine aortic valve replacement failed within seven years of its installation. My second bovine valve is now four years old, and doing well. I engage in aerobic physical activities and have a healthy diet. If my second gets stenosis, can a transapial valve be inserted in the bovine valve? The new valve sounds like a great development, but can it pass through the prosthetic and be effective? |
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Richard Holoubek says on October 7th, 2011 at 8:22 am |
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I had my aortic valve replaced two years ago and eveything is fine, however, when it’s time to have my bovine valve replaced,is it potentially possible that the transcatheter device can be used? |
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Julie says on April 10th, 2012 at 10:29 am |
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Is this product in trial in the US? |
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