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Repositionable transcatheter valve receives CE mark for larger size
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Direct Flow Medical has received a CE mark for the first fully repositionable 29 mm transcatheter aortic heart valve, according to a press release. The 25 mm and 27 mm valves had previously received a CE mark.
The double-ring design of the metal-free Direct Flow Medical valve conforms to the anatomy and creates a durable seal around the annulus, the company stated in the release. It is delivered via a flexible, 18F delivery system and has been designed to improve long-term survival by resolving the clinical issues associated with current commercial valves.
“As with the smaller sizes of the Direct Flow Medical valve, the implantation of the 29-mm valve is precise and fully controllable,” Christoph K. Naber, MD, of the Contilia Heart and Vascular Center, Essen, Germany, said in the release. “With this new valve size, a broader patient population will be able to benefit from the unique advantages of the Direct Flow Medical system.”
Christoph K. Naber
Before the valve’s approval, 6-month data from the DISCOVER CE Mark trial were presented at Transcatheter Cardiovascular Therapeutics 2013 and showed that among the 100 patients in the study, none experienced moderate or severe aortic regurgitation. There was a 96% survival rate, with 90% of patients in functional class I or II, according to the release.
The Direct Flow Medical valve is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgery.
The company also announced that it has completed enrollment in its US feasibility trial, which will lead to a pivotal trial on the valve later this year.
Perspective
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Peter Frambach, MD
The problem with transcatheter valves that have metal is that they lead to a fairly high percentage of aortic regurgitation and pacemaker implantation, which is not good for the outcome of the patient. When the 25- and 27-mm Direct Flow Medical transcatheter valve became available commercially in Europe in April 2013, I decided to switch to that valve because it has a metal-free polymer frame, and the first study done on this device showed that it was associated with a low rate of aortic regurgitation and pacemaker implantation. After a few implants, I was very satisfied that I could confirm the results of the study. Now, the availability of the 29-mm valve means that physicians in Europe will be able to treat larger annuluses, although an even larger size valve and a 23-mm valve (the latter we will be investigating shortly) would be helpful.
One important note with the Direct Flow Medical valve is that you need to do a proper valvuloplasty beforehand to prepare the annulus in order to achieve optimal results. If you have a well-prepared annulus and the right size valve and balloon, you will end up with very good results.
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