Stentex Stentex

For 2017, there are Medtronic only two joint ventures in the world - Ireland in and. Russia The implementation of a joint Russian-American investment project allowed Russia to begin to solve the problem of a high mortality rate of the population from myocardial infarction.

In accordance with the partnership agreement, with the support of the Russian government, advanced technologies for the production of coronary stents and catheters were transferred to the country and a production base was created. The main goals of cooperation are to provide patients with high-tech treatment of acute coronary syndrome and access to advanced technologies for attending doctors, fully cover the needs of the Russian market with a production base, and then enter the markets of other countries; localize additional technologies for other needs of Russian patients.

Areas of activity

According to the company for 2017, in Russia, more than 250 thousand patients need to carry out stenting and angioplasty operations using coronary stents and catheters annually. At the same time, this type of emergency aid in the Russian Federation is available only 110-115 thousand patients per year. The localization of the production of coronary stents and catheters in Russia has led to the fact that Stentex is ready to fully meet the needs of federal and regional health care institutions for coronary stents and catheters to provide assistance to those in need.

Stentex produces a number of Medtronic products, but the flagship products for 2017 were two types of coronary stents - metal and drug-eluting stents. The latter significantly reduce complications after surgery - thrombosis and restenosis.

Performance indicators

2017: Revenue exceeded 900 million rubles

Stentex, a joint venture of the Renova group of companies and the American company Medtronic, summed up its work in 2017 in January 2018. The company's revenue from the sale of coronary stents and catheters to the state for the reporting period amounted to 905 million rubles.

Stentex in 2017 sold 905 million rubles worth of medical products under state orders. Photo: pharmvestnik.ru

The process of localization of Stentex production in Russia, as of January 2018, is still not fully completed. As a result, Stentex supplies the state with imported stents (ST BRIG model - Ireland, Russia, Resolute Integrity model - Ireland, USA, Russia, ST Emercor model and ST NC Dylacor - Mexico, ST PROMPT model - USA).

As the representatives of the company explained, Stentex complies with the "localization schedule" approved by the Ministry of Industry and Trade and the Ministry of Health.

According to information presented on the public procurement portal, Stentex sometimes sold Medtronic stents more expensive than the manufacturer itself and other suppliers. In particular, the National Medical Research Center of Cardiology in 2017 purchased Medtronic stents (Resolute Integrity type) at a price of 52 thousand rubles apiece (supplier - Medtorg), while Stentex sold Medtronic stents of this type to Russian hospitals at a price of 61 thousand rubles apiece.

The difference in value in Stentex was explained by the fact that the prices for the company's products (since it has the status of a single supplier) are determined with the participation of "relevant departments." These prices "were brought by the Ministry of Health of the Russian Federation to healthcare institutions of the Russian Federation at the beginning of 2017." The company also indicated that Stentex shareholders have already turned to the government with an initiative "to reduce the price to the level of the current weighted average."

According to the company, the Russian Government in the second quarter of 2017 adopted amendments to the order, which made it possible to reduce the cost, for example, for covered stents to 46 thousand rubles apiece. Meanwhile, as of January 2018, the price of the company's products is already much lower than this mark, Stentex emphasized^[1]

Chronicle of events

2023: Appointment of Andrei Potapov as CEO of Stentex

In mid-March 2023, it became known about the appointment of Andrei Potapov as the new general director of the manufacturer of coronary stents "Stentex." In this position, he replaced Dmitry Belov. The relevant information is contained in the Unified State Register of Legal Entities (USRUL). Read more here.

2021: Medtronic's exit from the project

In early October 2021, it became known about the withdrawal of Medtronic from a joint project with Renova Group of Companies for the production of coronary stents - Stentex LLC. The reason is the imposition of US sanctions against Viktor Vekselberg's group.

According to the Ministry of Industry and Trade of the Russian Federation, Medtronic stopped the transfer of technologies and refused to further localize the production of its products on the territory of the Russian Federation "in connection with the introduction by the Office of Foreign Assets Control of the US Treasury of sanctions against Renova LLC.

Medtronic withdrew from a joint project with Renova Group of Companies for the production of coronary stents due to sanctions

The agency has developed an order according to which the stages of production of uncovered stents and drug-eluting stents, as well as balloon catheters, should be consistently localized in Russia.

Earlier, the Government of the Russian Federation approved Stentex as the only supplier of certain types of coronary stents and catheters. At the same time, the company must fulfill its counter obligations - the creation of production and the transfer of production technologies for these products according to the localization schedule, which is approved by a joint order of the Ministry of Industry and Trade of Russia and the Ministry of Health of Russia. Changes were made to the specified order of the Government, they provide for a reduction in the timing of the determination of Stentex by the only supplier, a change in the timing of product localization, as well as clarification of the names of medical devices. To update the provisions of the production localization schedule, the Ministry of Industry and Trade of Russia and the Ministry of Health of Russia have developed a corresponding draft order "On approval of the schedule and conditions for phased localization of production by the only supplier of stents for coronary arteries of uncoated metal, stents for coronary arteries that secrete a drug, balloon catheters standard for coronary angioplasty purchased by federal state budgetary institutions and state budgetary institutions of the constituent entities of the Russian Federation."^[2]

2019

Signing a memorandum on the establishment of the Center for Innovation and the Internet of Things in Healthcare in Russia

On June 6, 2019, a memorandum was signed between the international biopharmaceutical company AstraZenek, the Skolkovo Foundation, Nokia, Factory of Radiotherapy Technology LLC (R-Pharm group of companies), Russian Post, Stentex and Sberbank on the creation of a Center for Innovation and the Internet of Things in Healthcare on the basis of the Fund, which is scheduled to open in October 2019. Read more here.

The Ministry of Industry and Trade intends to expand preferences for Stentex to drug-eluting stents

In July 2019, it became known that the Ministry of Industry and Trade intends to expand Stentex preferences under the project to localize coronary stents on the Russian state order market. Stentex's right as a single supplier will be extended to the entire group of drug-eluting coronary stents. Prior to this, the company had advantages only for stents with a non-absorbable polymer coating.

Thus, the Ministry of Industry and Trade de facto intends to consolidate the decision of the Ministry of Finance, which in December 2017, when forming the Catalog of Goods, Works and Services (KTRU), combined two types of stents - with a non-absorbable polymer coating and with a absorbable polymer coating - into one group "stent for coronary arteries, releasing a drug," making Stentex a monopolist in this segment of coronary stents in the state order market.

The Ministry of Industry and Trade intends to exclude the aspiration catheter for emboloectomy (thromboectomy) from the list of MIs to be localized. The department justifies its decision with unprofitability: the use of this medical device is actually carried out in less than 7% of cases, and "the effectiveness of the use of this type of device in the treatment of acute coronary syndrome has not been confirmed," the explanatory note says.

In addition, the established final localization period will be extended for another year - until November 1, 2020 in connection with the sanctions imposed by the US Treasury.

Public discussion of the draft amendments to the Order of the Government No. 855 of May 12, 2015 will last until July 31, 2019.

US sanctions ban Medtronic from transferring Stentex technology

Renova is included in the list of companies whose assets are blocked in the United States and whose interaction is prohibited for American individuals and legal entities. In this regard, Medtronic (the operating headquarters is located in Minneapolis, USA) notified JSC Renova Group of Companies about the impossibility of continuing interaction and transfer of technologies under the joint venture Stentex Holding S.a.r.l. (is the sole owner of Stentex LLC), "- indicated in the explanatory note to the draft resolution of the Government of the Russian Federation.

The authors of the draft document emphasize that Medtronic's actions "led to the impossibility for Stentex LLC to complete certain measures to localize the production of medical devices on time."

2018

5 billion rubles were invested in the localization of stent production and another 4 billion will be invested in the coming years

In July 2018, it was announced that Stentex intends to increase the volume of stent production to 250 thousand medical products per year by 2020. This was announced by the general director of the company Yegor Lukyanov. According to him, the volume of investments in the localization of the production of Medtronic stents in Russia amounted to 5 billion rubles, another 4 billion will be invested in the coming years.

As Lukyanov told the Kommersant newspaper, Stentex has already managed to occupy 16% of the market for specialized medical products in Russia. What specific stents and catheters are meant, he did not specify.

In 2017, Stentex signed contracts for 880 million rubles, taking 29th place in the ranking of "TOP100 suppliers of medical products under state orders in 2017" of the Vademecum Analytical Center. At the same time, the market size of coronary stents (coated and not covered with a drug) and balloon catheters is estimated at 8 billion rubles.

At the same time, state customers ignore Decree No. 1469 "On Confirmation of Industrial Production on the Territory of the Russian Federation" adopted by the Government of the Russian Federation on December 4, 2017. Its essence is as follows: if an application comes to the competition from a domestic enterprise, then the customer has the right to reject the proposals of suppliers of foreign products.

From December 14, 2017 to the end of March 2018, the reference to PP No. 1469 in the tender documentation at thematic tenders, as the Ministry of Industry and Trade considered, customers delivered only in 157 cases. In total, 9.7 thousand coronary stents and 14.4 thousand catheters were purchased - for a total amount of more than 600 million rubles. These deliveries included products from the American Medtronic, Abbott Vascular, Boston Scientific, German Biotronic, Indian Meril Life Sciences and the Russian Stentex and Angiolain.

However, according to IMS estimates, only in January-February 2018, the total volume of thematic public procurement exceeded 2.3 billion rubles. This means that most customers either missed the moment of entry into force of PP No. 1469, or ignored the opportunity opened by the document to buy^[3].

Vekselberg and Renova Group of Companies fell under US personal sanctions

In April 2018, Viktor Vekselberg and Renova Group of Companies, which are co-founders of Stentex, fell under personal US sanctions. Medtronic promised to "assess the consequences of these sanctions."

Nevertheless, Stentex in July 2018 reported on the conquest of 16% of the market and promised to increase the volume of stent production by 2020 to 250 thousand medical products per year.

2017

State contracts for 880 million rubles

According to the results of the first year of operation, Stentex signed contracts for 880 million rubles, taking 29th place in the ranking of "TOP100 suppliers of medical products under state orders in 2017" of the Vademecum Analytical Center. At the same time, the market size of coronary stents (coated and not covered with a drug) and balloon catheters is estimated at 8 billion rubles.

Attempt 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^[4].

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.

Process Line Installation

As of March 2017, the plant is installing a production line, training and interning personnel. The plant should start operating in 2017, reach its design capacity by 2018.

The general director of the Stentex enterprise, Yegor Lukyanov, told the Rossiyskaya Gazeta correspondent that during the localization of production, the technologies and quality control systems of the entire line of medical devices of the American Medtronic, the world leader in the production of coronary stents and catheters, were transferred. This means that in the Russian Federation, the production of medical high-tech products is carried out strictly in accordance with the requirements applicable in any other Medtronic production abroad. The quality control system at Stentex complies with the most serious Russian and international industry standards.

2016

Status of the sole supplier of stenting products for the public sector until 2022

Stentex received marketing authorizations for four types of products in November 2016. While the production of stents is not localized in Russia, they are supplied by the Irish plant Medtronic. The company emphasizes that the products of the Stentex joint venture, focused on the production of products for the treatment of acute coronary syndrome, will not compete with the similar Medtronic range.

According to the order of the Government of the Russian Federation No. 855-r, for the next five years - from 2017 to 2022 - Stentex received the status of the only supplier of a group of medical devices for stenting, which are purchased by state medical institutions. Thus, Elena Plyasunova noted, the Government of the Russian Federation stimulates the attraction of innovative technologies and investments to the country.

Renova and Medtronic create Stentex to treat heart disease

On June 1, 2016, the Renova group of companies, owned by Russian oligarch Viktor Vekselberg, announced the creation of a joint venture with one of the world's largest manufacturers of medical devices Medtronic. A new company called Stentex will be focused on combating cardiovascular disease.

Stentex will create the largest research and production complex in Russia (the total area will exceed 11,000 square meters) for the production of coronary stents and catheters used in the treatment of acute coronary syndrome (occurs during the development of myocardial infarction).

Renova and Medtronic create a joint venture worth 9 billion rubles

It is assumed that the products that will be produced at the Stentex plant will allow more than 100 thousand stenting operations annually, helping to save the lives of Russian patients and reduce mortality from cardiovascular diseases. The company will create about 700 jobs.

Localization of production involves the transfer to Russia of all key technologies for the manufacture of stents and balloon catheters Medtronic, as well as the full implementation of a product quality control system. Total investments in the project will amount to about 9 billion rubles. How this amount will be divided between partners, companies do not disclose.

Medtronic's involvement in this joint venture reflects the commitment of our mission to ease pain, restore health and extend life, "says Medtronic Executive Vice President for Europe, the Middle East and Africa Rob ten Hoedt. - The challenge for Stentex is to contribute to addressing serious health care challenges. This project is also inextricably linked to Medtronic's strategic priority of globalization. Russia is one of the fastest growing markets that has great potential. We are proud that now our technologies will be used more widely in the fight against cardiovascular diseases and help save the lives of Russian patients.[5]

Notes