The World’s First VisONE® Implantation: a promising start

Below, we are re-publishing with permission the press-release issued by the Heart Institute on the 28th of September 2018

“Thanks to the efforts of the study team from the Heart Institute, we have conducted the first worldwide implantation of the VisONE system that we have developed, and we are going to demonstrate the benefits of the asymptomatic diaphragmatic stimulation (ADS) in heart failure patients and reduced ejection fraction”, – Peter Bauer, President and CEO of VisCardia Inc. in his report at the XIX Ukrainian National Congress of Cardiology (26-28th of September 2018, Kyiv).

On July 25, 2018, the first world-wide implantation of VisONE®, a medical developer VisCardia Inc., was carried out at the Kyiv Institute of Heart in clinical conditions. Thus, the start of an important Pilot Study on the VisONE Heart Failure Study in Ukraine was launched on the use of devices for the treatment of patients with heart failure.

Director General of the Heart Institute – Borys Todurov (left) and President and CEO of VisCardia Inc. – Peter Bauer.

The implantation was held under the control of the Director of Heart Institute, Associate Member of the National Academy of Medical Sciences (NAMN) of Ukraine, Professor Borys Todurov and the Study Principal Investigator Vitaliy Demyanchuk, MD, PhD.

In the 53-year-old patient with a left ventricular ejection fraction lowered to 17%, symptomatic heart failure was observed, despite the optimally chosen regimen of drug therapy. The lack of proper treatment outcome on the one hand and alternative therapies on the other, dictated the use of the VisONE® system.

Surgeon Oleksandr Plegutsa, MD, PhD who performed laparoscopic implantation, emphasized: “The practicality and feasibility of this new and minimally invasive approach reduces the time of the procedure, which is especially important for patients with heart failure. This allows them to recover more quickly than previously applied medical practices.” The implanted system is equipped with an electrical pulse generator, which provides asymptomatic diaphragm stimulation (ADS) to improve the function of the heart. The preclinical studies have shown that ADS improves acute hemodynamic parameters and left ventricular ejection fraction, remaining asymptomatic and devoid of side effects by the technique.

VisONE Heart Failure Study (NCT03484780) team (from left to right):
Igor Kuzmich, Oksana Pantazi, Evgeniy Zhytynskiy, Oleksandr Plegutsa, Piter Bauer, Vitaliy Demyanchuk, Nataliia Ponich, Mukhola Goncharenko, Oksana Davydchuk.

“We are very pleased that this innovative therapy approach will help patients who were previously almost doomed. Our Institute will actively and scrupulously study the effect of this method on heart failure”, – Professor Todurov, Director of the Heart Institute.

http://www.heart.kiev.ua/pershij-v-sviti-implantat-sistemi-visone-bagatoobitsyayuchij-pochatok/

 * The study is conducted by Clinical Accelerator

This entry was posted in Central and Eastern Europe, ClinAccel.Net, Clinical Accelerator, Medical Devices. Bookmark the permalink.

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