JenaValve Gets CE Mark For TAVI Device In Europe

As patients in the United States continue to wait for FDA approval of transcatheter aortic valve replacement devices, another TAVI technology just received a CE mark for commercial use in Europe.

Jena TAVI - Aortic Valve Replacement Via Catheter
JenaValve TAVI – Aortic Valve Replacement Via Catheter

Earlier today, JenaValve Technology, a medical device manufacturer in Germany, announced its receipt of a CE mark for its 2nd-generation transapical TAVI system. As you may know, these technological breakthroughs are used to treat patients with severe aortic valve stenosis 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).

Jena Valve TAVI
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 TAVI 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.

If you are curious, there are several competitors to the JenaValve, including the Edwards SAPIEN Valve and the CoreValve by Medtronic. Both devices have CE marks in Europe but have yet to receive FDA approval in the United States.

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 Pick
Written by Adam Pick

Adam Pick is a patient, author of The Patient's Guide To Heart Valve Surgery and the founder of HeartValveSurgery.com.

To learn how Adam has helped millions of people with heart valve disease, watch Adam's video, subscribe to his free newsletter, or visit his Facebook, or Twitter pages.

  • elias zaidman

    Why is Tavi not recomended for all patients instead of only high risk patients?

  • Doris Taylor-Marcus

    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?

  • Robert

    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.

  • Jim Hayden

    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?

  • Richard Holoubek

    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?

  • Julie

    Is this product in trial in the US?

Have A Question? Call Us at (888) 725-4311

HeartValveSurgery.com
P.O. Box 4049
Redondo Beach, CA 90277
Phone: (888) 725-4311