China's First Steerable Microcatheter Receives NMPA Approval: Cardiocycle's SteerFar QuYou® Marks a Milestone in Interventional Cardiology
CardioCycle
Innovative Medical Device Developer
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Heart Future
Recently,CardioCycle Technology (Suzhou) Co., Ltd.(Abbreviated as "CardioCycle"") under the ownership ofSteerFar®Controllable Bend MicrocatheterOfficially received the marketing approval (Registration Certificate No.: 20253031436) from the National Medical Products Administration (NMPA) of China, which isThe First Controllable Bend Microcatheter Approved for Marketing in China。
# Current Status of Treatment for Complex Coronary Lesions
Chronic Total Occlusion (CTO) of Coronary ArteryCTO）It refers to the complete occlusion of the coronary artery lumen caused by thrombosis due to the rupture of vulnerable plaques on the basis of atherosclerosis. The thrombus undergoes organization, fibrosis, and calcium salt deposition, resulting in persistent occlusion for more than 3 months. The lesion is hard and often accompanied by complex conditions such as vascular tortuosity and calcification, making interventional treatment difficult with a high incidence of surgical complications. Patients may experience cardiopulmonary symptoms such as chest tightness, chest pain, palpitations, and shortness of breath, which may be related to pathological changes such as myocardial ischemia and myocardial infarction.
CTOAnd bifurcation lesions are coronary intervention treatments (PCI) The universally acknowledged difficulty in China.
CTO The lesion accounts for approximatelyPCI Surgery20%(CurrentPCIPassed200With tens of thousands of patients and a huge market, the controllable bending technology has just entered the coronary intervention market. The angles between the main and branch vessels are highly variable, plaque distribution is complex, and the failure rate of guidewires entering the branch vessels is as high as30%, the risk of postoperative branch occlusion increases compared to单纯的主支病变.2-3 Times.
Such lesions place extremely high demands on the maneuverability, support force, and vascular adaptability of microcatheters.Controllable Bend MicrocatheterHas become the core device for breaking through technical bottlenecks.
The design of the controllable bend microcatheter aims toEnhance the precision and safety of surgery, especially in neuro and cardiovascular surgeriesIn China. Such catheters are typicallyAchieve bending by manipulating the pull wires to adapt to complex vascular structures.。
# AboutSteerFarQu You®Controllable Bend Microcatheter
This product is composed of a bending control handle, stress relief tube, catheter, and hydrophilic coating, and is suitable forInjection or infusion of contrast media and/or fluids and/or embolic materials (embolic microspheres, embolic microparticles), and/or appropriate devices (coils) into peripheral and coronary vessels.。
1. Can be achievedBidirectional 180° Dynamic Curve Adjustment: Complex Bifurcation“Navigation System”
Precisely Match Vascular Morphology: Bidirectional operation can be achieved through the handle knob. 180° Angle Adjustment,Bending radius as low as 2mm，Can precisely match the angulation of bifurcation lesions (e.g. > 90°) and tortuous vascular segments.
Improve Guidewire Passage Efficiency: In the reverse guidewire technique (RWT). The adjustable bending function can assist in forming the guidewire.“Hairpin-shaped”Shaping significantly improves the guidewire passage rate at branch openings. Data from a certain Class III hospital shows that using angled processing> 70° Bifurcation lesions,The time for the guidewire to enter the branch averaged 12 Minutes shortened to5 Minute.
2. Thin-walled large-cavity structure: Compatible with more devices and embolic agents
Optimize Device Compatibility: Adopt 1.7F-2.7F Multi-Specification Outer DiameterDesign, compatible with more devices:0.010’’And0.014’’Guidewire, Microspheres and0.018’’Coil.
Balance of Support and Flexibility:The tube body adopts a double-layer tungsten wire braiding process, and the radial support force is improved compared with traditional single-layer braided microcatheters. 40%, in jailed guidewire technique orCrush During stent procedures, it provides a stable guidewire support platform while maintaining tip flexibility.
3. Comprehensive Specifications and User-Friendly Design
Multi-size Adaptation: Provide 125cmAnd150cm Various LengthsAnd1.7F-2.7F Outer diameter options can precisely match from the radial artery to the femoral artery.
Ergonomic Handle for Asians: Designed to fit the hand shape of Asians, with a short operational travel for the bending adjustment knob (1 Cycle Completed180° Adjust the curve to reduce operator fatigue and improve intraoperative control accuracy.
# Application of Controllable Bend Microcatheters in the Cardiovascular Field
1. Chronic Total Occlusion of Coronary Artery (CTO) Interventional Treatment
In the case of a blurred proximal fibrous cap, tortuous collateral vessels, or the need for retrograde accessCARTTechnical ComplexityCTOIn lesions, steerable microcatheters are applied to:
Entering Branch Vessels
Re-enter the true lumen
Delivery of guidewire in acute branch
Advantages:Reduce the need for guidewire pre-shaping and enhance the controllability of microchannel navigation.
2. Structural Heart Intervention
Especially in the application of atrial septal puncture and left atrium navigation:
Bicuspid Valve Intervention
Left Atrial Appendage Occlusion
Paravalvular Leak Closure
Delivery of Steerable Sheath
Advantages:Accurately target the fossa ovalis or the opening of the left atrial appendage to reduce fluoroscopy time.
3. Peripheral Vascular Intervention (PVI）
Complex occlusive lesions through the iliac artery, superficial femoral artery, or tibial artery
Embolization procedure involving branch vessels (e.g., uterine fibroids, endoleaks)
Advantages:A deflectable tip helps bypass calcified plaques or tortuous branches.
4. Cardiac Electrophysiology Monitoring and Ablation (EP）
For pulmonary vein isolation, atrial mapping, and ablation therapy
Some electrophysiological catheters integrate steering control and mapping sensor functions.
Advantages:Achieve precise positioning and ensure stable contact with the endocardial surface.。
# AboutCardioCycle
CardioCycle (Cardiocycle）Founded in2021In the year, the company focused on providing one-stop solutions for interventional therapy, covering CardioCycle and pan-vascular intervention. The operations were respectively based in Suzhou.BiobayAnd IrelandGalway GMITEstablish production and R&D centers, committed to becoming an interventional medical solutions provider specializing in research, development, and manufacturing.
2024Year5In the month, the opening ceremony of CardioCycle's headquarters base was grandly held in Phase V of Suzhou Biomedical Industrial Park. The headquarters base, located in Phase V of Suzhou Biomedical Industrial Park, which has been activated this time, covers an area of3200Square meters. Main products includeEmbolic microspheres, various balloons, catheters, and sheathsetc., currently the company12All product lines are advancing simultaneously, and all products possess full independent intellectual property rights.
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