PETAH TIKVA, Israel, Feb. 6, 2019 /PRNewswire/ -- A groundbreaking piece of medical technology was revealed to the public today at the National Research Center for Cardiac Surgery in Astana, Kazakhstan. At a press conference held at the Center, top heart failure experts from around the world announced the successful implantation of FIVAD (Fully Implanted Ventricular Assist Device) into a human.

A few hours before the press conference took place, an article about the FIVAD implantation was published by the prestigious Journal for Heart and Lung Transplantation  (JHLT). 

Among the guests from the medical community participating in the event; Professor Mandeep Mehra – Professor of Medicine - Harvard Medical School, and Editor-in-Chief of The Journal of Heart and Lung Transplantation as well as Professor Nir Uriel – Director, Heart Failure, Transplant and Mechanical Circulatory Support, University of Chicago and the Charmian of the Mechanical Circulatory support council at the International Society of Heart Lung Transplantation.

FIVAD is based on technology created by Leviticus Cardio, a medical technology company headquartered in Israel. It uses patented Coplanar Energy Transfer (CET) to wirelessly power a heart pump – a Ventricular Assist Device (VAD). FIVAD incorporates a heart pump produced by Jarvik Heart Inc, an established manufacturer of ventricular assist devices.

Every year, VADs are surgically implanted into thousands of patients with severe heart failure in lieu of heart transplants. VADs need to continuously be connected to a power source which requires patients to have a wire coming out of their bodies. This not only severely reduces the patients' quality of life but, in over 20% of cases, causes infections which can lead to hospitalization and severe complications.  

FIVAD is a fully implanted VAD system, a Jarvik 2000 pump, powered wirelessly using both internal and external components designed by Leviticus Cardio, which allows patients to walk around without any physical impediments for up to 8 hours a day.

After years of development and animal testing, the first implant of FIVAD in a human took place in December at the National Research Center for Cardiac Surgery in Astana, Kazakhstan. The operation was a success. The patient has been discharged from the hospital and is back leading a normal life. He was in the audience during the press conference and later sat down for interviews with journalists.     

FIVAD is also equipped with a back-up system (Jarvik Heart, Post Auricular driveline connection) which would allow moving to traditional wired power in case the wireless system failed. While the back-up was tested during the implant procedure, it has not been needed since that initial implant test.

The leading cardiologists and cardiac surgeons who participated in the press conference included:

Dr. Pya Yuriy Vladimirovich – CEO of National Research Center for Cardiac Surgery in Astana, Kazakhstan – Lead FIVAD surgeon

Professor Ivan Netuka - Chairman of the Department of Cardiovascular Surgery, Surgical Director of Chronic MCS and Heart Transplantation, Institute for Clinical and Experimental Medicine, Prague- participated in FIVAD surgery

Professor Stephan Schueler - Consultant Cardiothoracic Surgeon at Newcastle upon Tyne Hospitals Trust and renowned cardiothoracic surgeon

Assoc. ProfessorJiri Maly – Deputy director/CMO of Institute for Clinical and Experimental Medicine, Prague - participated in FIVAD surgery

Dr. Yigal Kassif – Attending Cardiac Surgeon and Chief of Cardiac Surgery Intensive Care Unit at Sheba Medical Center in Israel.

Assoc. Professor Jiri Maly who participated in the FIVAD surgery said "We were really satisfied how easy it was to position the internal components of Leviticus' system during surgery. It exceeded our expectations during the operation. Simplicity of surgery has definitely contributed to the patients' early recovery." 

Professor Nir Uriel "This is a significant improvement in the quality of life experienced by the patient. The patient has the freedom to go about his daily routine without having to worry about being connected to a power source via a driveline and can forget for a few hours that he is supported by an LVAD. We, the medical community, cardiologists, cardiac surgeons, VAD coordinators and the patients have wanted this for decades."  

Michael Zilbershlag, Leviticus Cardio's CEO and Peter Hinchliffe, Jarvik Heart Inc. president and COO, together stated "The FIVAD system is a game changer for anyone suffering from severe heart failure. We hope that this successful operation will be the first of many and that our system will soon provide thousands of patients with the ability to carry on with a normal life, despite their disease."

About Leviticus Cardio - leviticus-cardio.com

Founded in 2008, Leviticus Cardio (Leviticus-cardio.com) is a medical device company dedicated to improving the clinical outcome for patients with an implanted left ventricular assist device (LVAD) for the treatment of impaired cardiac function. The Company has received funding from The Trendlines Group, Israel's foremost seed- and early-stage investment group, a consortium of acclaimed cardiovascular physicians, private investors and Israel's Innovation Authority (previously, the Office of the Chief Scientist of the Ministry of Economy).

About Jarvik Heart

Jarvik Heart, Inc. is a private company that develops miniaturized heart assist devices for the treatment of severe heart failure. The company, formed in 1988, is located in Manhattan, where it conducts development and manufacturing activities. The Jarvik 2000® Ventricular Assist Device has successfully sustained and improved the condition of patients awaiting transplants as well as those who have chosen the device for lifetime use.

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SOURCE Leviticus Cardio; Jarvik Heart

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http://leviticus-cardio.com