SOURCE: HeartStitch, Inc.

Heartstitch, Inc.

June 29, 2016 08:28 ET

Revolutionary New Heart Procedure Performed for the First Time in Patients -- Brings Worldwide Attention to Kazakhstan

HeartStitch®, Inc. aAnd National Cardiac Research Center In Astana Announced That It Has Performed The First In Man Transapical Access Procedure on Worldwide Premier Of First In Man Trans-Apical Access Closure With Minimally Invasive HeartStitch® Technology On Two Patients

ASTANA, KAZAKHSTAN--(Marketwired - June 29, 2016) - New New medical technologies in medicine have alwayshave typically come to Kazakhstan from other countries. This all changed on June 14, 2016 when Dr. Y.V. Pya and his colleagues, along with renowned British Cardiologist Dr. Michael Mullen and medical -device inventor Prof. Anthony Nobles successfully performed the new procedure successfully on 2 on two patients at the National Cardiac Research Center in Astana. The "First In Man" procedure of cardiac transapical access and closure using the Heartstitch technology was accomplished without the use of a prosthetic implant was performed in two patients https://kaztrk.kz/index.php/kz/a/2180

http://khabar.kz/ru/news/obshchestvo/item/58928-revolyutsionnyj-metod-operatsij-na-serdtse-razrabotali-v-rk

. The Both patients who were requiring replacement of their aortic heart valve received the HeartStitch® transapical procedure, allowing the team to place the Heart Valve safely into the beating heart. The patients tolerated the procedure very well and have been discharged without complication. This procedure will eventually make it possible to perform critical heart procedures percutaneously through a small puncture between the ribs rather than open heart surgery. In the years to come, this technology has the potential offor saving thousands of lives all over the world. This was also These procedures also marked the first time in Kazakhstan's history that a medical technology was firstinitially tested in humans here first, -a technology that in part was developed in Kazakhstan, and will be built and exported to other countries.

Dr. Pya, the Chairman and CEO of the National Cardiac Research Center, comments on thised on the event: "The field of cardiac surgery inaround the world is developing toward less invasive medical care. It is much Although moreWhile more beneficial for the patient however,, it is is however much more difficult to implement at the beginningits inception. What we were able to accomplish today is a major contribution totoward achieving this goal, and it will be very welcomed by the medical community worldwide. I am very happy with our success and I thank my team and also, as well as those from HeartStitchthe HeartStitch® team, who participated in this tremendous work."

Dr. Mike Mullen, consultant cardiologist andat St. Bartholomew's St. Barts Heart Hospital, London, and Chief Medical Officer of HeartStitch®, Inc., commented, "this exciting technology will be an important step in facilitating the next wave of technology in treating structural heart disease that will require safe, effective and simple access and closure of the ventricular apex.I believe this is the next wave of technology in treating structural heart disease. The ability to be less invasive without introducing new mechanical devices into the patient's heart by emulating the open surgical technique is always the best way, but often the most difficult to achieve. This new technology does just that. Over the next year our task will be to refine the procedure, technology, and technique of using the device so that it may be implemented by cardiac teams performing these life saving heart operationsprocedures."

Shigeo Katsu, President of Nazarbayev University, Astana Kazakhstan commented, "HeartStitch® is an important part of the innovation directive of Nazarbayev University to broaden research out to the world. This First In Man procedure will change the lives of two Kazakh citizens, and will be the beginning of this technology helping people all over the world. I personally, am proud of student directly involved in making these successful procedures possible and look forward to further innovation as part of our international collaboration with Heartstitch® , Inc."

The road to developDeveloping and testing this new innovation which led up to this day , and the road leading up to its first use, took several years. Doctors from the National Cardiac Research Center worked side by side with engineers from HeartStitch®, Inc. (a manufacturer of medical devices that works in Kazakhstan in partnership with Nazarbayev University and the National Cardiac Research Center) in Kazakhstan, Los Angeles (US), Zwickau (Germany), and Paris (France). Engineers from Heartstitch's Kazakhstan affiliate designed parts of the final device. One of these engineers is Yerkanat Nurmakhanov, a graduate of the inaugural class of the School of Engineering of Nazarbayev University. His inventions on this and other products will become the basis for international and Kazakhstan patents.

This technology makes it possible for cardiologists to access the heart through the apex by a minimally invasive procedure. Access to the apex is then closed by using only surgical suture (and not leaving a device in the heart). When widely used, this technology will make thousands of people worldwide eligible for medical treatment of their structural heart disease. With the current state of structural heart therapy, these patients have either to undergo open heart surgery or be limited to care available through the femoral vein access. On the day of the First In Man, deployment of the newly developed instrument helped to save the lives of two people in Kazakhstan, who are now on their way to recovery.

This technology makes it possible for cardiologists to access the heart through the apex by a minimally invasive procedure. Access to the apex is closed by using only surgical suture (and not leaving any devices in the heart). When this technology is used widely, thousands of people in the world will become eligible for medical treatment of their structural heart illnesses. With the current state of structural heart therapy, these patients have either to undergo open heart surgery or be limited to care available through the femoral vein access. On the day of the First In Man, deployment of the newly developed instrument helped to save the lives of two people in Kazakhstan, who are now on their way to recovery.

Prof. Anthony Nobles, Chairman, CEO and Chief Clinical Specialist of HeartStitch®, Inc., stated, "This is a historical day for all of us, w. Whenever we perform a First In Man ofwith one of our new technologies, we recognize that we are entrusted with not only the lives of these patients, but the hopes of tens of thousands of patients thatmore who in the future will rely on this procedure for their lives. As a scientist there is no greater measure of your work than the ability to save a life. As a businessman we are, I am also proud of the impact this has had on the people of Kazakhstan, -our partners in this development. The ability It's been very gratifying to demonstrate the incredible talent and expertise of the doctors, engineers and all involved in bringing this technology to reality both in Kazakhstan and the USA. The HeartStitch® TA (http://www.heartstitch.com/heartstitch-ta/) is one of ourthe greatest examples of our worldwide collaboration. I am personally very proud forto have had this opportunity to work with Dr. Pya, who I believe is one of the most talented cardiac surgeons in the world. We believe this is also a historic moment for Kazakhstan to show the world that It's all proof positive that real medical innovation is not only possible here in Kazakhstan, but will continue to grow aswill continue to grow with this collaboration with Heartstitch. This moment marks significant growth of a new industry."

This was a historic day for the Cardiac Center, HeartStitch, Inc. and Nazarbayev University. This invention has the potential of revolutionizing the field of cardiology. Transapical access opens a door to several types of medical care previously not available to many patients and can improve the quality of care compared with the currently available technology. With time, as cardiologists use this technology on a daily basis, everyone will remember that it started in Kazakhstan.

About Nazarbayev University

Nazarbayev University is a modern and rapidly developing international university located in the heart of Eurasia - Astana, the capital of the Republic of Kazakhstan. The University serves as a cluster designed to create favorable conditions for innovators, assist in introducing the results of research and development to the market, and form a ring of research-intensive and technology companies around Nazarbayev University. It must also create a favorable environment for researchers, attracting investments to new technology research within Nazarbayev University, developing engineering potential in Kazakhstan, fostering transfer and commercialization of cutting-edge technologies, and creating jobs for Nazarbayev University alumni.

For more on Nazarbayev Univeristy visit www.nu.edu.kz

About National Cardiac Research Center

The National Cardiac Research Center is the leading Cardiac Surgery Organization in Central Asia, offering medical services and high-quality service. It was established by the order of the President of the Republic of Kazakhstan N. A. Nazarbayev and opened theits doors on October 12, 2011.

The main clinical directions of the Center are:

  • Treatment of the congenital and acquired heart diseases
  • Coronary heart disease
  • Heart failure
  • Cardiac rhythm disturbance

- Treatment of the congenital and acquired heart diseases;

- Coronary heart disease;

- Heart failure;

- Cardiac rhythm disturbance.

For more on National Cardiac Research Center visit www.heartcenter.kz

About HeartStitch®

HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on the innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures. HeartStitch HeartStitch® currently markets under license the NobleStitch™ EL device for cardiovascular suturing and PFO closure. HeartStitch™ develops new structural heart technologies through its international innovation development teams in California, Kazakhstan and Germany.

The HeartStitch® TA is FDA cleared for vascular suturing in the United States. For more on HeartStitch® visit www.HeartStitch.com

HeartStitch® is a registered trademark of HeartStitch, Inc.

HeartStitch® TA for cardiac suturing and transapical access and closure

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, and 8709020.

HeartStitch® MR for suturing an anatomical valve

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8348962, 8469975, 8496676, 8709020, and 8771296.

NobleStitch™ EL for PFO closure

Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.

For more on HeartStitch® visit www.HeartStitch.com

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