Veryan Medical's BioMimics 3D Helical Peripheral Stent Receives NMPA Approval, Exclusively Distributed by MicroPort's Endovastec in China

Sep 23, 2024 22:15 CST Updated 22:15

Veryan

Medical Device R&D Manufacturer

Veryan MedicalAnnouncing its unique three-dimensional helical structure peripheral vascular stent---BioMimics 3DApproved by NMPA for marketing in China, and will be distributed by Xinmai. Approved by NMPABioMimics 3DFor the treatment of atherosclerotic occlusive disease of the superficial femoral and popliteal arteries.

In lower extremity artery disease (LEAD), femoropopliteal artery occlusion accounts for approximately 47% to 65%. Femoropopliteal artery occlusion can cause a series of clinical symptoms such as intermittent claudication and chronic limb-threatening ischemia, posing a serious threat to the patient's quality of life, limbs, and even life.

According to the data released in the "Chinese Expert Consensus on the Diagnosis and Treatment of Femoral-Popliteal Artery Occlusive Disease 2022": Statistical data from 2010 showed that the number of global LEAD patients was 202 million, and it has increased by 13.1%-28.7% over the past decade. In a study involving 4,055 Chinese people aged 60 and above, the prevalence rates of LEAD in men and women were 2.9% and 2.8%, respectively. Currently, the population of elderly individuals aged 80 and above in China is increasing at an annual rate of 5%, and the incidence of LEAD is also rising accordingly.

Lower Limb MovementPulse disease is a condition with a very large patient population. The main current treatment methods include conservative drug therapy and revascularization therapy. Among themRevascularization is the only option for patients with severe symptoms or ineffective drug treatment.In Blood RevascularizationEndovascular treatment methods are increasingly becoming the preferred treatment for femoropopliteal artery occlusion due to their advantages of minimal trauma, quick recovery, easy tolerance, and repeatability.

However, due toThe femoral-popliteal artery, due to its unique physiological structure,At rest, long and relatively straightSuperficial Femoral ArteryThe shear stress on the inner wall of blood vessels is relatively low, which makes it prone to atherosclerosis and delays the healing process. Of course, implantationThe straight stent will further straighten the blood vessel, thereby disrupting the normal blood flow pattern and creating areas of low wall shear stress.Low Wall ShearShear stress is the triggerThe main factors of atherosclerosis, thereforeStraight stent implantation cannot truly solveFemoral-popliteal artery stenosis.

Veryan MedicalAccording toA unique understanding of the femoral-popliteal artery has led to the development of a three-dimensional helical peripheral vascular stent.BioMimics 3D。BioMimics 3DThe unique three-dimensional helical structure can effectively address low wall shear stress, thereby avoiding/reducing secondary stenosis after implantation.

Its clinical efficacy has also been confirmed in clinical studies:

Post-marketing real-world study (MIMICS-3D) shows: The 3-year primary patency rate is 70%.BioMimics 3DIn high-risk patient populations, such as severely calcified lesions (PACSS grade 3-4) and chronic total occlusions (CTO), it also demonstrated strong performance: the 3-year f-CDTLR (freedom from clinically driven target lesion revascularization) rate was 77.6% for PACSS grade 3-4 lesions (Vs. 78.7% for PACSS grade 0-2 lesions), and the 3-year f-CDTLR rate was 75.6% for CTO patients (Vs. 81.0% for non-CTO patients).

BioMimics 3D

BioMimics 3DIt is a peripheral nitinol stent with a unique 3D helical geometry that imparts a gentle helical shape to the popliteal artery.

BioMimics 3DDeveloped based on bionic principles, with a unique three-dimensional helical structure that simulates the natural curvature of human blood vessels, reducing stimulation and damage to the vessels. It promotes the formation of physiological vortex-like blood flow within the stented segment, increasing shear stress on the vascular endothelium. This serves to reduce intimal hyperplasia, resist atherosclerosis, and prevent restenosis.

BioMimics 3DTheThe three-dimensional helical shape exhibits excellent biomechanical performance, allowing it to better accommodate various deformations of the femoral-popliteal artery caused by human movement. It effectively reduces localized strain in the stented segment, thereby decreasing the risk of stent fracture.

BioMimics 3DSpecification Model

Veryan Medical

Veryan MedicalIt is an innovative medical device company and a subsidiary of Otsuka Medical Devices. The Japanese company Otsuka is also a major shareholder of MicroPort.