Innovative vascular graft: Molds to the artery and dissolves

Endovascular prostheses can save a patient with cardiovascular pathology, but they can also cause complications. The founder of IK Sovremennye Tekhnologii (part of the Russian Friends Capital investment fund), surgeon Leonid Glushchenko, shared the story of how he invented biodegradable grafts that have shape memory and are self-expanding and how he dreams of taking the product to international markets.

A bit of theory

Endovascular stenting procedure is a minimally invasive surgical method that involves installing a special device (a stent graft) in an artery affected by atherosclerosis to restore its lumen. A catheter with the stent folded at the end is inserted through the femoral artery to reach the affected vessel. Before installing the stent, the lumen of the artery is expanded with a balloon.

In 1974, Dr. Andreas Gruentzig performed the world’s first peripheral human balloon angioplasty; since that time, stent-graft systems have evolved to fourth-generation devices.

Endovascular stent grafting has definite advantages. There is no need for general anesthesia, as local anesthesia at the site of puncture or section of the vessel does it; there is no need to connect the patient to a cardiopulmonary bypass; the procedure involves minimal pain, quick recovery and short hospital stay.

However, the method requires expensive equipment, X-rays and special training of surgeons. Endovascular stenting is performed only at large medical centers. The procedure can also involve complications such as arterial thrombosis or vascular perforation followed by bleeding. As a result of thrombosis, acute and subacute stent occlusion develops in 2–11% of cases, and subacute stent thrombosis in 10% of cases. However, anticoagulation therapy and more advanced implants reduce the frequency of complications to 1–4%.

The first fourth-generation devices were made for coronary arteries and caused more complications than metal stents. According to Abbott spokesperson Jonathon Hamilton who spoke to StarTribune:

“Absorb is a first-generation device that took longer to implant than metallic stents. Sales volume for Absorb was low, and it cost more to make Absorb than what it sold for — making it unsustainable. We continue to work on second-generation bioresorbable technology with a smaller profile and improved deliverability to reduce implantation time.”

Today scientists around the world are working to improve fourth-generation devices.

Personal reasons

Leonid Glushchenko works as an endovascular surgeon at the Ulyanovsk Region Clinical Hospital and installs implants for patients who suffered a heart attack, patients with atherosclerotic vascular disease in lower limbs and a risk of pulmonary vessel thrombembolia.

“We started this project for personal reasons,” Leonid recalls. “My grandfather was at a risk of pulmonary vessel thrombembolia and needed an implant. But I know that in 33% cases standard metal implants cause complications. Therefore, I started seriously thinking about developing stents that would be made of a different material. It was a long search but eventually I found an advanced polymeric material that suited this purpose.”

The next step was finding investors, testing the device and selecting technical research. His company, IK Sovremennye Tekhnologii, was registered in 2012.

“Two or three times I thought that nothing was going to work out,” the surgeon says. “But eventually the prototype was made and tests are currently underway.”

Life-saving polymers

For almost four years, Leonid and his team experimented with polymers and eventually developed vascular stents that take the shape of the artery and dissolve completely in the body over time.

“Human arteries are often curved,” Leonid explains. “Therefore, we needed to create implants that would follow the shape of the artery without damaging it.”

Polymers are used in making flexible implants that follow the shape of arteries. The developer received a patent on the invention and technology. A dissolving polymer stent is a wire structure in the shape of a cylinder which supports the artery walls by reopening narrowed arteries and improving blood flow, thus preventing thrombosis.

Sovremennye Tekhnologii was initially created as a micro-enterprise with just one employee, Director Leonid Glushchenko. Later on, he searched for engineers who would be engaged in creating implants at his design. He hired six people, each of whom have their own job: one is responsible for the design, the second for the selection of materials, the third develops production technologies, the fourth is engaged in project conception, while the fifth employee does the actual manufacturing. General Director Leonid Glushchenko supervises the entire process of stent making.

Skolkovo resident company comes into spotlight

In 2014, Leonid Glushchenko’s company became member of the Nuclear Innovation Cluster in the city of Dimitrovgrad in the Ulyanovsk Region. The same year, he started negotiations with the Skolkovo innovations center aiming to make Sovremennye Tekhnologii its resident company. This became reality three months later, in April 2014, which allowed the company to attract investments and conduct experiments on animals in Moscow laboratories.

A total of RUR 20 mio ($288K) has been invested in the project; another RUR 50 mio is required for improving and promoting the product, Leonid says. Currently, Sovremennye Tekhnologii is conducting experiments in labs to test endovascular devices. Investments provided by Skolkovo allowed Leonid and his colleagues to travel to the United States and China, do some work in local laboratories, and study the two countries’ experience in manufacturing such grafts.

In 2019, Sovremennye Tekhnologii began cooperating with Dmitry Kulish, Professor at the Skolkovo Institute of Science and Technology. Due to its close cooperation with the Skolkovo innovations center, the company took part in its accelerator and won contests to take part in accelerators that took place in the USA and China. Leonid keeps in touch with major medical centers in Ulyanovsk, Moscow and many other cites.

“Our prospective clients are hospitals that conduct endovascular stent surgeries,” Leonid says. “Every year, some 100K such surgeries are performed, and our products are relevant for the medical industry. We are planning to enter Russia’s market and foreign ones as well; this is why we are carrying out tests at laboratories abroad. Our immediate aim is to start clinical testing, complete it by 2022 or 2023, and start selling our new grafts,” he concluded.          

By Christina Firsova

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