BIOABSORBABLE RAPAMYCIN ELUTING
CORONARY STENT SYSTEM
Bioheart bioabsorbable drug-eluting stents provide good biocompatibility and its degradation products can be absorbed by the human body. Based on its own function, the product can repair and reconstruct tissue function for patients, specifically revascularization, functional recovery and stent absorption. During the revascularization period, the stent provides radial support to the vessel at the lesion site, lasting for no less than 6 months (clinical results show that the lumen diameter tends to be stable about 3 months after PTCA). With the precise release control design of the drug coating, the stent can adequately endothelialize (the stent structure is completely covered by neointima, and the degradation debris will not protrude into the blood vessel to avoid affecting blood flow or developing embolism).During the functional recovery period of PTCA, the stent no longer restricts the contraction and expansion of blood vessels, allowing them to make natural responses to physiologic stimulation and gradually reduces the radial strength, until it loses structural continuity in the course of self-degradation. In the absorption phase, the stent is degraded into carbon dioxide and water, which is absorbed benignly by the human body.
BALLOON DILATION CATHETER
A Balloon dilation catheter is used to reduce vascular stenosis and occlusion to improve myocardial perfusion. As an instrument commonly used today before stent implantation during PCI, coronary balloon pre-dilation is a principal tool to dilate the stenosis of coronary artery, relieve vascular stenosis and ensure the smooth implantation of stents, which is a decisive factor for the success of PCI.
Due to the precise control of the dilation size, the high-pressure balloon catheter does not experience a "dog bone" effect and it is resistant to high pressure which is usually used for the re-dilation after the stent implantation to achieve the perfect plasticity of the stent.
PULSE BALLOON DILATATION
Pulse balloon dilation catheter excites energy instantaneously in the electrode inside the balloon based on the pulse power supply and generates a pulse shock wave at the excitation electrode, which is transmitted to the capsule wall and vascular tissue through the development solution in the capsule. When the shock energy reaches the calcified portion of the vascular tissue, the instantaneous shock will break-up the calcified portion in the tissue, so that the calcified blood vessel segment becomes softened, The calcified vessel stenosis will be smoothly dilate by a filling pump.
ULTRA THIN-WALL BIOABSORBABLE
RAPAMYCIN ELUTING CORONARY
A thinner-wall generation of fully absorbable coronary stents has the minimum thickness, less than 100μm. With a thinner wall, the product will bring the following benefits.
① Brings a smaller profile (contour diameter) of the stent, offering better controllability and flexibility, and providing convenience for the operator to deliver the stent to the target lesion;
② A thinner wall enables good lumen gain immediately after stent implantation;
③ Better stent apposition after implantation;
④ There is minimal turbulence around the stent struts, reducing the possibility of aggregation of platelets to cause thrombus in stent;
⑤ More consistent Endothelialization of the stent after implantation;
⑥ The thinner-wall stent reduces the number of implants, which is beneficial to absorption by the human body;
BIOABSORBABLE RAPAMYCIN ELUTING
INFRAPOPLITEAL STENT SYSTEM
Bioheart bioabsorbable rapamycin eluting infra-popliteal stent is used to treat primary peripheral artery stenosis by percutaneous artery intervention, improve the blood flow of the patient's inferior knee artery and prevent restenosis. Reference vessel diameter ranging from 2.50 mm ~3.75 mm. The length of lesion is no more than 35 mm.
Bioheart bioabsorbable rapamycin eluting infra-popliteal stent platform is made of L-polylactic acid, and the thickness of its wall is less than 100μm.
The drug coating is composed of rapamycin, a macrolide antibiotic widely used in clinic, and racemic polylactic acid (PLA), a bioabsorbable polymer, by unique proportions.
It is a unique drug release control technology with proprietary intellectual property rights, achieving targeted drug release by drug distribution in different proportions on the stent pillar.
There are two radiopaque platinum development points at both ends of the stent, and the stent offers good visibility on X-ray to ensure accurate implantation when long lesions need multiple stents.
The system is equipped with a performance-optimized integral interactive conveying system.