Revolutionary New Heart Valve Repair -- Performed for The First Time In Patients -- Demonstrates Feasibility of New Suture Based Technique
Published: Apr 10, 2018
ASTANA, Kazakhstan, April 10, 2018 /PRNewswire/ -- Following up on the First-In-Man of the Heartstitch® TA procedure for Trans-Apical Access and Closure performed in Astana in 2016, Dr. Yuri Pya again has been the first in the world to perform the new suture technique for repairing the Tricuspid Valve in 2 patients in Astana, Kazakhstan at the National Research Cardiac Surgery Center.
Dr. Y.V. Pya and Dr. Timur Lesbekov along with medical-device inventor Prof. Anthony Nobles proctoring successfully performed the new technique on two patients at the National Research Cardiac Surgery Center in Astana. The "First In Man" procedure of cardiac tricuspid valve repair was accomplished using the HeartStitch® Remo Pro suture technique. Both patients required repair of their tricuspid heart valve to remodel the annulus of their tricuspid valve for the treatment of tricuspid regurgitation. 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 access from the jugular vein rather than open heart surgery. In the years to come, this technology has the potential for saving thousands of lives all over the world. These procedures continue to show the growth of 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 Research Cardiac Surgery Center, commented on the event: "Structural heart surgery around the world is developing toward less invasive medical care. In most cases these less invasive techniques are beneficial for the patient, however to take an open surgical procedure and make it as effective when using the percutaneous techniques is a significant challenge. What we were able to demonstrate with these first two procedures was a major step forward in achieving the goal of percutaneous "surgical suture" based tricuspid valve repair. Since the completion of these successful cases we have now performed more than 10 cases in the last couple months all successfully. We believe this technique is the first clinical step in proving the safety and efficacy of this novel technique. I am very happy with this success and I thank Prof. Nobles, Dr. Lesbekov and my team, as well as those from the HeartStitch® team, who participated in this clinical milestone."
Kazbek Aubakirov, Director of EMS (the Kazakh subsidiary of HeartStitch® a manufacturer of medical devices that works in Kazakhstan in partnership with Nazarbayev University and the National Research Cardiac Surgery Center) based in Astana, Kazakhstan commented, "HeartStitch® is the first of its kind medical device company in Kazakhstan and through its collaboration with Nazarbayev University and the National Cardiac Center of the innovation and clinical applications of these technologies has demonstrated that we are able to compete at the highest level in the world theater of medical device development and clinical implementation. This First in Man technique performed by Dr. Pya and his team will change the lives of two of my fellow Kazakh citizens, and will be the beginning of a treatment that will spread around the globe. I personally, am proud of what we have accomplished at EMS and Nazarbayev University to make this possible and I look forward to continuing to bring the HeartStitch® Remo Pro to the world market."
Developing and testing this new technique, and the process leading up to its first human implementation, took several years. Dr. Pya and Prof. Nobles worked side by side with engineers from HeartStitch®, Inc. in Kazakhstan, Los Angeles (US), Zwickau (Germany), and Paris (France). This international collaboration has continued to demonstrate the success that can be achieved to provide these lifesaving medical innovations.
This technology makes it possible for cardiologists to access the heart through the jugular vein by a minimally invasive procedure to reach the tricuspid valve and repair the coaptation of the leaflets without open heart surgery. 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 to undergo open heart surgery. On the day of the First In Man, deployment of the newly developed technique 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 our second new innovative First In Man of a new procedural technique with Dr. Pya and is a historic day for all of us. This was the first step in the clinical development of our latest suture-based device the HeartStitch® Remo Pro for treating mitral regurgitation. The success of these two cases has provided critical physician feedback to our design that will be implemented in our upcoming First in Man clinical testing of the new HeartStitch® Remo Pro dual needle system which is planned in the next 90 days. We believe this will change the face of structural heart surgery, adding another treatment to our line of suture based structural repair devices which already include the HeartStitch® Access Pro for trans-apical access and closure, the HeartStitch® Coap Pro for mitral valve repair and the NobleStitch™ EL for PFO and ASD closure, which recently published its data demonstrating superior safety in percutaneous suture based closure (https://www.prnewswire.com/news-releases/noblestitch-el-italian-registry-data-published-in-eurointervention-300626377.html)".
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 University visit www.nu.edu.kz
About National Research Cardiac Surgery Center
The National Research Cardiac Surgery 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 its 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
- For more on National Research Cardiac Surgery Center visit www.heartcenter.kz
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® 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® Access Pro (formally HeartStitch® TA) and the HeartStitch® Coap Pro (formally the HeartStitch® MR) are FDA cleared for vascular suturing in the United States.
HeartStitch® is a registered trademark of HeartStitch®, Inc.
HeartStitch® Access Pro
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® Coap Pro
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.
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
For more information, please contact: USA In Kazakhstan --- ------------- Dru Dobbs Kazbek Aubakirov P. +1 714 427 6348 P. +7 777 5009005 F. +1 714 427 6343 kaubakirov@HeartStitch.com ddobbs@HeartStitch.com Nazarbayev University Jannet Turarbekova firstname.lastname@example.org National Research Cardiac Surgery Center Asel Mazhibayeva email@example.com
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