Peripheral arterial disease, in general, and lower extremity peripheral arterial disease, in particular, represent a significant and growing challenge in global healthcare. These conditions affect approximately 3% of the population and tend to progress with age.
Endovascular revascularization is currently regarded as the most advanced surgical treatment for this condition, thanks to its minimally invasive and minimally traumatic approach. This results in a significant reduction in mortality and disability for patients. The procedure involves dilating the vessel lumen using a balloon catheter and subsequent implantation of a special metal mesh structure, or stent. There has been a steady increase in the number of endovascular interventions for peripheral arterial disease in the Russian Federation every year.
One of the key factors limiting the number of endovascular technologies and hindering the provision of timely high-tech medical care is the lack of high-quality, competitive domestic stents. The vast majority of consumables (up to 90%) used in revascularization procedures are manufactured abroad. In line with the import substitution policy pursued by the Russian Government and in order to maintain the sovereignty of the Russian Federation, Almazov Centre is developing a prototype domestic self-expanding stent that is comparable in quality to, and in some cases superior to, foreign alternatives.
In line with the project initiated by the Committee for Science and Higher Education of the St. Petersburg Government, the researchers of the Research Department of Vascular and Interventional Surgery conducted a series of preclinical tests on the implantation of a domestic self-expanding nitinol stent for peripheral arteries on biological models. The tests were carried out at the Preclinical Translational Research Centre of Almazov Centre under the guidance of Dr. Mikhail Chernyavsky. The prototype line was successfully tested, confirming the product's safety and efficacy.
Samples of the stent were previously exhibited at the VII St. Petersburg Medical Innovation Forum in May 2024, Health Forum 2024 in July 2024, and are scheduled to be displayed at the Development Fair on 24-25 November in Moscow.
The Almazov Centre's development and early introduction of domestic self-expanding nitinol stents into clinical practice within the framework of the ‘Health’ priority national project will undoubtedly contribute to the improvement of the quality of medical care and health promotion in the Russian Federation.