The staff manufactures and manufactures bioabsorbable coronary rapamycin-eluting stents.
Recently, in the 10,000-level GMP standard purification workshop of Shandong Huaan Biotechnology Co., Ltd. located in Kouzhen Street, Laiwu District, the reporter saw that scientific researchers are concentrating on the production of bioabsorbable rapamycin Element-eluting stents. It is also the birthplace of the first biodegradable coronary drug stent product in China.
“Heart stents may be familiar to everyone. Traditional metal stents can help open narrowed blood vessels, but they will remain permanently in the body, and will also increase the safety of long-term thrombosis and in-stent restenosis. Risk. In addition, many patients will also have feelings of worry, anxiety and other emotions because of the permanent ‘foreign body’ in the heart. The emergence of bioabsorbable coronary rapamycin-eluting stents has largely solved the above problems ” said Wei Zheng, general manager of Shandong Huaan Biotechnology Co., Ltd.
Shandong Huaan Biotechnology Co., Ltd. was founded in February 2008. It is an early domestic enterprise engaged in the research and development and application of bioabsorbable materials. The company has a total investment of 320 million yuan, covers an area of 100 acres, and has a total of It is a high-tech enterprise invested and established by Weigao Group, specializing in the research and development, production and sales of minimally invasive medical devices.
Since its establishment, the company has been aiming at the most cutting-edge medical devices in the world, setting up a research and development team led by experts in the medical and polymer fields, holding a number of independent research and development patented technologies, and is committed to the development of bioabsorbable A professional company in polymer material research and vascular implantation/interventional medical devices, positioned in the domestic market, serving the society and benefiting patients and medical workers.
During more than 10 years of hard work, we have overcome many technical difficulties, made breakthroughs in many key technologies, mastered the core technologies mastered by only a few multinational companies in the world, and successfully developed domestic first and world-leading technologies. The bioabsorbable stent, the bioabsorbable coronary rapamycin-eluting stent system, was approved by the State Drug Administration for marketing on March 5, 2020. This product is based on new material research and application technology, involving biopharmacology research, solid mechanics research, medical clinical experiment and implantable medical device production and other technical fields. The fourth innovation in post-coronary interventional therapy.
It is understood that the bioabsorbable coronary rapamycin-eluting stent system consists of a balloon-expandable absorbable coronary stent, a drug coating and a delivery system. High-temperature melting to make precision polylactic acid pipe, the polylactic acid pipe is cut into stent shape by femtosecond laser according to professional design drawings and scientific stress analysis, and after spraying a layer of special formula on the surface of the stent, it is bundled with the delivery system. Together, the absorbable coronary drug stent system is finally made. The stent is based on PLLA polylactic acid, and is coated with a drug coating mixed with PDLLA polylactic acid and rapamycin. After implantation in the blood vessel, the drug is slowly released. The stent gradually degrades into carbon dioxide and water in 2-3 years, and the blood vessel recovers its elasticity. The product can effectively solve the clinical problems of mechanical traction, foreign body inflammatory reaction, vascular intimal hyperplasia, late thrombosis, restenosis and other clinical problems of metal stents, and maximize the performance advantages of new absorbable and fully degradable biomaterials: non-permanent implantation In vivo, while inhibiting intimal hyperplasia and reducing the incidence of restenosis, it can also reduce the long-term existence of foreign bodies and drug residues in the body. The long-term safety and efficacy are favorable for re-interventional therapy.
Up to now, product sales have covered more than 30 provinces, municipalities and autonomous regions, with more than 100 channel distributors and more than 120 hospital admissions. “In the future, the company will lead the research and development team to continue to increase research and development efforts, and in line with the quality policy of ‘product quality is the company’s life, customer satisfaction is the company’s pursuit’, we will continue to make good products for curing diseases and saving people.” Wei Zheng said. (Love Jinan Client)