For 2017, four companies produce stents in Russia, data from Deputy Minister of Economic Development Yevgeny Yelin quoted RBC as saying:

• "Stentex,"
• "Medinge" (Penza),
• Angiolaine (Novosibirsk),
• " Stentonic" (Tula).

Chronicle

2023

Preferences in public procurement

On May 19, 2023, it became known that the Ministry of Industry and Trade of the Russian Federation amended Decree of the Government of the Russian Federation No. 617 of April 30, 2020 "On restrictions on the admission of certain types of industrial goods originating from foreign countries for the purpose of procurement to meet state and municipal needs." We are talking about giving preferences to Russian coronary stents and some other medical devices on public procurement.

The document regulates the application of the so-called "second extra" rule. In accordance with the new norms, if at least one participant with products that are included in the list of products produced in the EAEU enters the public procurement auction, all other applications from foreign suppliers must be rejected. This requirement applies to three products: "Balloon catheter standard for angioplasty" (OKPD code 2 32.50.13.110), "Stents for coronary arteries secreting drug" (32.50.22.190) and "Stents for coronary arteries, metal uncovered" (32.50.22.195).

The Ministry of Industry and Trade gave preferences to Russian coronary stents and some other medical devices on public procurement

The amendments provide for other changes. In particular, the ban on competition between suppliers offering Russian products with comparable characteristics is lifted. In addition, bidders will not have to submit documents to customers confirming the country of origin of the goods (that is, decisions on the basis of which they were entered in the register of the Ministry of Industry and Trade or the list of the Eurasian Economic Union).

According to the Ministry of Industry and Trade, Russian enterprises are able to supply over 700 thousand coronary stents and about 650 thousand balloon catheters annually. Key market players are R-Vascular JSC, Stentonic JSC, RK Group LLC, Nanomed LLC and Stentex JV (with localized Indian Translumina).^[1]

Digital marking

In January 2023, coronary stents in Russia began to be digitally labeled. The introduction of labeling will help contain the illegal circulation of medical products and protect consumers from falsification, since counterfeit products are often found on the market, which are illegally imported into Russia without proper control, the press service of the Center for the Development of Advanced Technologies (CRPT, operator of the Honest Sign labeling system) reported. Read more here.

Implantation of the first Russian stent-graft

Surgeons of Krasnoyarsk [Federal Center for Cardiovascular Surgery (Krasnoyarsk)|Federal Center for Cardiovascular Surgery]] successfully implanted the first Russian multi-wound stent-graft in a patient with dissection of the thoracic and abdominal aorta. The press service of the Ministry of Health of the Russian Federation announced this on January 18, 2023.

A 60-year-old man entered the center of cardiovascular surgery of the Krasnoyarsk Ministry of Health with a life-threatening condition - aneurysm and aortic dissection throughout it. The natural course of such a disease leads to mortality, and interventions for aneurysm and aortic dissection belong to the highest category of complexity and are associated with a high risk.

Krasnoyarsk surgeons implanted the first Russian stent-graft in a patient

Destruction of the walls of the aorta leads to tear of the inner shell and blood under high pressure delaminates the walls into two parts, and sometimes completely tears the aorta with an imminent fatal outcome. For the patient, the only chance of life is timely cardiac surgery.

As noted in the Ministry of Health, the first operations on this pathology were performed in the 60s of the XX century, but the mortality rate remained extremely high. We had to do multi-stage interventions in 2-3 operations during the year, and this is a great risk for the patient. With the development of technology, a prosthesis was developed that combines a stent-graft and a synthetic prosthesis into one whole. Implantation was performed during one operation, this procedure acquired the name "Frozen Elephant Trunk" - Frozen Elephant Trunk.

In the Cardiocenter of Krasnoyarsk, we began performing such operations in 2020 and used prostheses from British and German manufacturers, since there were no such stent grafts on the domestic market. Now we have the opportunity to implant a domestic multi-wound stent-graft in patients with aneurysm and dissection of the thoracic and abdominal aorta, - said Alexei Andin, head of the cardiac surgery department No. 1 of the Federal Center for Cardiovascular Surgery of Krasnoyarsk of the Russian Ministry of Health.

According to him, the first operation with the Russian product was successful - the prosthesis completely closed all areas of rupture of the thoracic aorta.^[2]

2020

Reduction in the cost of coronary stents on public procurement by 36.8% over 4 years

In 2020, the weighted average cost of coronary stents in public procurement in Russia amounted to 25.2 thousand rubles against 39.9 thousand rubles in 2017. Thus, this type of medical devices has fallen in price by about 36.7% in four years.

In this case, we are talking about stents for coronary arteries with drugs per unit of production on state orders. Prices for stents for coronary arteries metal uncovered from 2017 to 2020. decreased by 26.7%, to just over 12 thousand rubles. Such data are provided by Roszdravnadzor in accordance with clause 4 of the Order of the Government of the Russian Federation No. 855-r dated 12.05.2015, regulating the procedure for state purchases of medical devices for coronary angioplasty within the framework of the state guarantee program.

The weighted average prices calculated by Roszdravnadzor act as a restrictive barrier in public procurement. It was established that their value in the state supply contract cannot exceed the indicator of the previous year.

By the end of 2020, Stentex LLC, a joint venture between Medtronic (51%) and Renova Holding Rus (49%), remained the only supplier of stents in the domestic market (in accordance with Government Order No. 855-r). Special conditions for the state procurement of coronary stents are aimed at further developing the localization of foreign manufacturers of goods for cardiac surgery and cardioplasty in Russia.

The share of domestic solutions is growing in the structure of the Russian coronary stent market. This was also facilitated by support measures provided for by the state program "Development of the pharmaceutical and medical industry" for 2013-2020 in the areas of subsidizing clinical trials of implantable medical devices and organizing the production of medical devices.^[3]

Put Niy Coronary Stent Registration at Roszdravnadzor

In October 2020, the Russian-Indian company RK Group registered two types of coronary stents in Roszdravnadzor, which began to be produced in Chechnya. Read more here.

Russian manufacturers of coronary stents retain benefits

In early February 2020, it became known about the decision of the Ministry of Industry and Trade of Russia to extend the validity of benefits for domestic manufacturers of coronary stents when working with government orders.

The former protectionist regulations, described in Government Decree No. 1469 of December 4, 2017, were in effect until July 2018. Then it was extended until December 2019, and now - until 2022.

The Ministry of Industry and Trade of Russia will extend the period of benefits for domestic manufacturers of coronary stents in the segment of the government order market

The Ministry of Industry and Trade will extend preferences for the production of stents for coronary arteries both in the uncovered version and in the modification providing for the delivery of the drug. In addition, we are talking about catheters for agnioplasty.

It is specified that products of foreign origin should be withdrawn from trading in the presence of at least one offer from domestic companies. The updated regulation retains the ban on combining catheters and stents with other medical devices. The department also plans to determine the requirements for confirming the production of products at Russian sites.

The ban on combining stents and catheters with other names of medical devices in one lot or contract in the new regulation is preserved.

At the same time, the Ministry of Industry and Trade will establish a list of minimum actions confirming production in Russia. In the case of catheters, the list includes all activities - from elementary assembly to packaging and installation of final identification labels.

With regard to stents - installation, positioning and fastening of the stent on the delivery system cylinder, quality control, final packaging of the medical product with installation of identification labels. Elementary assembly of the stent with the application of a drug coating will become a mandatory technological operation from December 1, 2021.^[4]

== 2017 ==

Market volume - 6-6.5 billion rubles

According to MDpro data presented in January 2018, the annual volume of the coronary stent market is about 6-6.5 billion rubles, in physical terms - 160-170 thousand products.

The market for balloon catheters looks a little more modest - its volume is 1.8-2.2 billion rubles, or 100-120 thousand products.

The revenue of Stentex at the end of 2017 exceeded 900 million rubles. Thus, the company managed to win an eighth of the market.^[5]

Stentex is trying to monopolize the coronary stent market

In January 2017, representatives of Renova asked the government to oblige to purchase stents only from Stentex, RBC wrote, the Ministry of Economic Development and the Federal Antimonopoly Service did not agree.

In June 2017, it became known that the Ministry of Industry and Trade wants to oblige Viktor Vekselberg to purchase coronary stents from Stentex. The draft resolution of the Ministry of Industry and Trade, published on regulation.gov.ru, proposes to purchase 90% of coronary stents from a single supplier, and to form the price based on contracts with Stentex LLC (it localized the production of Medtronic stents, USA) in 2017-2024. If the supplier localized production, the draft resolution says, he should have the results of three years of post-registration clinical trials with at least 2,000 patients; if planning to localize, then at least 10,000 people. The representative of the Ministry of Industry and Trade believes that any organization can be the supplier.

The owner of 51% of Stentex is Medtronic, 49% is Renova Holding Rus, 90% of which, according to the Unified State Register of Legal Entities, is Viktor Vekselberg.

In May 2015, the government appointed Stentex as the only supplier of stents from 2017 to 2022. Hospitals can, but are not required to conclude contracts with it without bidding. Hospitals prefer a single supplier so as not to conduct a tender, Alexander Stroganov, general director of the State Order Placement Center, knows. According to SPARK-Interfax, in 2017 Stentex signed 58 contracts for 556 million rubles^[6].

The resolution is the actual monopolization of the market, an employee of a medical engineering company is outraged: purchasing from a single supplier was a right, not an obligation, and the project obliges to purchase 90% from a single supplier. The current decree concerns 60% of the coronary stent market, and the upcoming one is almost everything, he is horrified.

Purchasing from a single supplier determined by the government is not an obligation, but a right, customers can purchase stents from other manufacturers, the FAS representative disagrees.

To certify medical devices, toxicological and clinical trials are needed on dozens of patients, says an employee of the manufacturer of medical equipment. No Russian company has studies with the number of patients indicated in the draft resolution, employees of two of them know.

According to the general director of Stentex Yegor Lukyanov, the studies lasted more than five years, more than 15,000 patients participated in them. Angiolain in 2016 launched post-registration studies with a smaller number of patients than required by the Ministry of Industry and Trade: it compares its stents with those of one of the leading manufacturers studied on tens of thousands of patients, according to the company's medical director Oleg Volkov. If you prove the identity of stents, the company may fall under the criteria of the Ministry of Industry and Trade, says an employee of one of the manufacturing companies.

Russian doctors did not allow Minek to import substitution of coronary stents and catheters

On February 17, 2017, the Government of the Russian Federation discussed with representatives of the medical community the initiative proposed by the Ministry of Economic Development to include coronary stents and catheters of foreign production in the list of medical devices subject to restrictions in public procurement in the event of domestic analogues. Russian doctors called the localization of production a solution to the problem of import substitution of medical products. Read more here.

See also

• Coronary stents in Ukraine

Notes