Penza, 17 December 2015. PenzaNews. The enterprises of the Penza biomedical cluster “Biomed” have developed a new transcatheter heart valve, announced head manager of “MedInzh,” board chairman of the cluster Sergei Yevdokimov during the press conference at “Rameev” technopark held on Thursday, December 17.

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He pointed out that the new development was created under a cooperation of the engineers and Vladlen Bazylev, chief medical officer of the federal cardiovascular surgery center (FCVSC) under the Russian Health Ministry.

“Normally, installing a heart valve requires to stop the heartbeat. This means the cardiosurgery is a very difficult one: we induce cardioplegia, remove the native damaged valve and install an artificial one. But this system allows to replace the valve without stopping the heart,” he stressed.

Sergei Yevdokimov also explained the know-how behind the achievement.

“The microaccess system inserts the valve attached to a small balloon. It expands, grows in size, replaces the damaged native valve, and the patient quickly returns to their normal life after the operation without any complications. Such operations are usually extremely expensive, frankly speaking. The cost of the system we are showing you was about 1 million rubles before the ruble situation: imagine how much it costs now,” he added.

In turn, Vladlen Bazylev, who was also present at the press conference, explained that such systems currently cost around 24,000-26,000 euros.

In the meantime, the Penza system costs only 600,000 rubles, Sergei Yevdokimov added.

“But the key here is not just the cost. Thanks to our mutual cooperation, advice and ideas, this system is much less complicated than the one the US producers offer,” he stressed.

Expanding the topic further, Vladlen Bazylev pointed out that the system can be evaluated only after clinical tests and human research.

“Afterwards, we can tell if it is good, bad, or just like [the foreign alternatives],” the CMO stressed.

The system already underwent animal tests, but it may not be used in human surgeries until registration, he added.

“The ideas implemented, the achievements suggested let us say this system will perform better. It is much easier to install, at the very least. This is very important, because the device will be shipped in ready-to-install form, while the foreign models also take 20-30 minutes to adjust before the operation. Besides, the warranty term will be much higher than the imported systems, because we offer using only artificial materials in the implants, and the warranty terms for artificial materials are unlike the bio-grown ones used in foreign systems,” he said.

According to Vladlen Bazylev, the competitive level of the system can be estimated after official registration and the whole test cycle.

“But I can tell you that our colleagues ‘on the opposite side of the world’ are not slouching either. The line gets updated constantly, every two years. For example, Edwards, the company that makes such systems, spends $1 billion on R&D. So we have to compete – a bagful of money there, mostly enthusiasm here,” he said.

The federal cardiovascular surgery center CMO also noted that the system was presented at one of the trade shows in the “Biomed” cluster zone, and attracted particular interest by foreign colleagues.

He added the system potentially will also be available for export.

“We believe we will overcome everything. And most importantly, we have great enthusiasm and the wish to make something, to implement something new,” Vladlen Bazylev stressed.