ASTANA – Nazarbayev University and the HeartStitch company opened a “clean room” for the production of medical devices in Astana Sept. 20.
The company is one of the first projects of the Astana Business Campus and is closest to commercialising some of its projects in the field of biomedicine. By producing high-tech medical products in Kazakhstan, the company hopes to significantly increase the country’s export potential.
“I have built 28 companies in the medical devices production field. I have been building medical products during all my career. And I wanted to do something different, something more expansive. I didn’t want to build another company and sell it. I really wanted to create something bigger to make a difference. The main motivation for me was that I can build an industry different from that which you have in your country and I can also bring my way of teaching, my method of exciting people about the things we do,” said Anthony Nobles, CEO of HeartStitch, about his decision to launch a production centre in Kazakhstan.
Until now, there were two main methods for treating structural heart diseases: open heart surgery or a less invasive technique to implant a device in a patient’s heart. Both methods have their advantages and disadvantages: open heart surgery is efficient, but traumatic to the body. Implanting a device is a less dangerous surgical procedure, but perhaps not as effective. HeartStitch invented an alternative that combines the efficiency of open heart surgery and the benefits of minimal trauma to the body.
This new method allows cardiologists to sew cardiovascular tissue through a catheter, leaving no implants. Using this approach, HeartStitch developed a range of products. One is NobleStitch EL. The device is recognised around the world and is rapidly gaining popularity. The unit can be sold in Europe and was approved by the U.S. Food and Drug Administration. It is used to treat heart defects that can lead to stroke. This device helps to treat people who have had a stroke, especially young people, and people suffering from certain types of migraine.
The clean room opened by HeartStitch with the support of Nazarbayev University corresponds to the highest international standards. After the necessary training and certification process, the new production site will send its products to hospitals in Kazakhstan, EU countries and the Commonwealth of Independent States. Currently, the clean room has one set of basic equipment and the staff has been trained in the company’s production site in California. Kazakhstan has received a license for the production and manufacture of medical devices and is preparing for the certification of each type of product.
Head of the National Research Cardiac Surgery Centre (NRCSC) Yury Pya is a strong supporter of the project and contributes to the research, development and use of the devices.
“High quality things are produced by people like you and me. And we must believe in ourselves; believe that we can produce such devices. It is crucially important. The NRCSC was established recently from scratch, and I believe that everything else can be made as well,” he said.
Interventional Cardiologist of the NRCSC Saule Kadirova was the first expert in the former Soviet Union to use NobleStitch devices.
“We have been working with NobleStitch devices for a year and we have performed 16 surgical operations using the technology and the devices. The first eight operations were controlled by foreign experts, but other operations were performed without any control or contribution of foreign experts,” she said.
“As for me, I am absolutely confident in any product made in Kazakhstan. I really trust our producers more than foreign ones, because our people do their best,” she added.
Nazarbayev University continues to provide support for the company’s business development and growth. In addition to the equipment of this industrial complex, the university plans to allocate additional space for a clean room and office that will allow the company to continue to grow. By producing high-tech medical products, HeartStitch hopes to provide employment opportunities and provide an example for other manufacturers of medical devices to launch production in Kazakhstan.