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JenaValve Gets CE Mark For TAVI Device In Europe

Posted by Adam Pick on October 5th, 2011

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 A dad, a husband and a patient, Adam Pick founded this website in 2006 to educate you about heart valve surgery from diagnosis to recovery.
You can get the latest updates about heart valve surgery from Adam at his Facebook, and Twitter pages. Click here to email him.

 


elias zaidman says on October 5th, 2011 at 2:16 pm

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

 


Doris Taylor-Marcus says on October 5th, 2011 at 4:09 pm

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 says on October 5th, 2011 at 10:40 pm

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 says on October 6th, 2011 at 4:32 pm

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 says on October 7th, 2011 at 8:22 am

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 says on April 10th, 2012 at 10:29 am

Is this product in trial in the US?

 

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