The project «HeartStitch»: Innovations in Cardiac Surgery

«NURIS» jointly with the American company «Heartstitch» implement the project, which will significantly improve the process of treatment of structural heart disease. This is a completely new fabric stitching technology through minimally invasive surgery. On the basis of Technopark will be releasing the device «NobleStitch EL» - the first product based on this method. Production in Astana will be in accordance with international GMP standards. According to the company's strategy, it will be the second production site after the head office in the US (city Fountain Valley, CA). Subsequently, this product will be sent to the hospital Kazakhstan, EU and CIS countries.

Advantages of the technology:

Until now, in cardiac surgery, there are two main methods for the treatment of structural heart disease: open surgery or implantation devices with minimal intervention in the human body. Company «HeartStitch» invented an alternative that combines the efficiency and advantages of both methods. This technology allows the cardiologist to crosslink cardiovascular tissue through the catheter, leaving no implants. On the basis of this approach «HeartStitch» has developed a range of products. The first device - «NobleStitch EL» - has been recognized throughout the world and is in demand in hospitals. The invention is approved by the US FDA (Administration of Quality Supervision Food and Drug Administration) for sewing cardiovascular tissue, and allowed to be sold in Europe. «NobleStitch EL» will help to reduce the risk of recurrent cryptogenic stroke, decompression sickness in people of certain professions, as well as in the treatment of various types of migraine.

The principle of operation of the device can be viewed on video: https://www.youtube.com/watch?v=sX-I1Ose7cY&feature=youtu.be

Current project status:

American specialists have implemented the technology on the territory of Kazakhstan and has trained cardiologists. On the basis of JSC "National Science Cardiac Surgery Center" and JSC "National Scientific Center of Surgery" after A.N. Syzganov was conducted 28 operations on the heart with using «NobleStitch EL» device. These operations are carried out regularly in the leading clinics of Europe.

In the industrial park created "clean room" in accordance with international standards in the field of medical devices production. It established the basic equipment; the staff has been trained in California. Office in Kazakhstan got license for production and manufacture of medical devices, and is preparing an application for certification of each type of product.

«HeartStitch» company became a resident of the Technopark in March 2016. Most of the Kazakhstan office staff totaled by graduates of "Nazarbayev University". Project Manager Kazbek Aubakirov, LLP "Educated Medical Solutions".

Руководитель проекта – Казбек Аубакиров, ТОО “Educated Medical Solutions”.

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Открытие «чистого помещения» для производства изделий медицинского назначения в Технопарке Назарбаев Университета, 20 сентября 2016 г.
На фото: Канат Байгарин – Вице-Президент по инновациям и науке, АОО "Назарбаев Университет"; профессор Энтони Ноблс – основатель HeartStitch Inc.; Massimo Pignatelli – Декан Школа медицины, АОО "Назарбаев Университет". 

Main goals:

The first phase of production - assembly products - requires the utmost precision and requires absolute sterility of the device. These conditions show's ability to meet the stringent requirements for admission to the sales of medical devices in Europe and in the CIS countries.

In the future we plan to expand the range of products - to produce devices for trans apical  access to the heart, for the treatment of mitral valve by technique of Alfieri and annul plastic, closing ASD and VSD (defects atrial and ventricular septal). Recently, the company held the first two operations on man: in Astana - on trans apical access and in Linkoping (Sweden) - the closure of VSD. The news of these events was announced on the main congresses of cardiologists in Europe, USA, Dubai and was well received by the international medical community. As a result, Kazakhstan was marked on the world map of medical innovations as the country to which you should pay attention.

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Doctors JSC "National Science Cardiac Surgery Center" and Kazakh engineers are directly involved in the conduct of clinical research and development «HeartStitch» future products. In addition, local experts have perfected the device «NobleStitch EL», and its creator, Professor Anthony Nobles, praised the functional qualities of the new model.

HeartStitch

Операция по закрытию овального окна в АО «Национальный научный кардиохирургический центр» с использованием изделий HeartStitch

Want to know more?

Detailed information about the company and the technology on the official website of the company www.heartstitch.com