Cardiocycle's AccuFar Micro Guidewire Receives NMPA Approval for Vascular Interventions

Product Information

Registration Certificate Number：JS Medical Device Registration No. 20242031999

Registrant Name：CardioCycle Technology (Suzhou) Co., Ltd.

Product Name：Micro-guidewire

Management Category：Class II

Structure and Composition/Main Components：

Product byMicro-guidewire, Rotator, and Shaping NeedleComposed of three parts, with the torsion device and shaping needle as accessories. The micro-guidewire consists of a wound wire, core wire, TPU polymer sheath, and coating, with a hydrophilic coating applied to the outer surface of the TPU polymer sheath.

Scope of Application/Intended Use：

Used forGuide other instruments into blood vessels, establish a percutaneous access pathway conducive to intravascular devices, or perform intravascular positioning, or establish intravascular access.

Product Features：

• Excellent torque control, good tip compliance, and superior tactile feedback,With excellent plasticity and memory capabilities，For super-selective small vessels；Can reduce the number of repeated plasticizations, alsoCan be reshaped multiple times.

• Integrated Core Stainless Steel Wire + Distal Coil Structure, with good torque performance.

• TPU + Customized CoatingThe outer layer composition provides excellent shaping ability.

• 0.014" / 0.016" / 0.018" 3 Diameter Specifications，Length: up to 2 meters (80-200cm)。

• Strong adaptability, with balloon occlusion microcatheter, microcatheterGood tube fit。

• Full-body stainless steel core wire,The outer layer has a TPU coating at the distal end and a "customized Accu formula coating" of PEFE at the proximal end. Hydrophilic coating design enhances pushability.Reduce friction with blood vessels, easy to pass through。

• The TPU coating at the head end of the guidewireBetter Flexibility, during the process of establishing a distal access,Providing soft vascular contact.

• Precise Tactile Feedback, which can accurately convey the position of blood vessels to the operator and control the movement direction of the guidewire;High Compliance FlexibilityEasily pass through different vascular pathways;Sufficient IntensitySupport the pushing of other instruments;Various ModelsMeet a variety of clinical needs.

• AccuFar0.014'' Designed for Super Selection

• Tapered tip for easier access to tortuous vessels, enabling super-selective positioning and entry into peripheral vessels.
• The platinum alloy winding at the head end, with a length of 120mm, enables precise measurement and positioning under DSA.

• AccuFar0.018'' Designed for high-flow microcatheters

• Reducing the gap between the micro-guidewire and the high-flow microcatheter provides excellent trackability and compatibility;

• A single-axis wire ensures torsional control, and when passing through severely curved lesions, it guarantees excellent vascular tracking and high operability.

Part of the approved micro-guidewire products made in China

Traxcess™ Microguidewire is composed of a core wire and a coil wire. The core wire is made of stainless steel and nickel-titanium alloy, and the coil wire is made of platinum-nickel alloy. The product includes accessories such as a shaping rod, insertion tool, and torque device.This product is suitable for general intravascular use., including the nervous and peripheral vascular systems. The direction of the guidewire can be controlled to allow for selective placement of diagnostic or therapeutic catheters.Not applicable to coronary arteries。

DCwire® Microguidewire is composed of a core wire, coil, and hypotube. The distal surface of the microguidewire has a hydrophilic coating, and the accessories include a torquer and introducer.The product is suitable for the neurovascular system and peripheral vascular system., used to establish access and guide the insertion or placement of diagnostic or therapeutic devices within blood vessels.

China Sky Patrol™The micro guidewire is composed of a tip, distal core wire, connecting ring, proximal core wire, and hydrophilic coating. Each micro guidewireThe silk package is equipped with one accessory guide catheter and one torque.For intravascular diagnosis and interventional procedures, including the neurovascular system and peripheral vascular system.

The hybrid core wire welding design enables seamless connection between nickel-titanium and stainless steel core wires.Provides 100% torque transmission and higher torque strength, making the operation faster and safer during the procedure.An extra-long proximal stainless steel core wire provides stable and strong proximal support and pushability.The 3cm platinum-tungsten marker coil at the distal end is designed for convenient intraoperative feedback operation.The tapered gradient change of the distal core wire provides excellent tip shaping and retention capability;30cm ultra-smooth hydrophilic coating provides excellent intravascular passage and tracking.The product was approved to enter the Chinese market in April 2022.。

The product is composed of a core wire, a tungsten-containing TPU sheath, platinum-nickel coiled wire, and a hydrophilic coating. The core wire consists of PTFE-coated stainless steel and nitinol core wires connected by a nitinol tube.Applicable to neurovascular and peripheral vascular, assisting diagnostic or therapeutic instruments to reach the lesion site smoothly.The product was approved to enter the Chinese market in December 2020.。

# About CardioCycle

CardioCycle was founded in 2021, the company focusesProvide a one-stop solution for interventional therapy, covering CardioCycle intervention and pan-vascular intervention.Production and R&D centers have been established in Biobay, Suzhou, and GMIT, Galway, Ireland, committing to become an interventional medical solutions provider specializing in R&D and manufacturing.

In May 2024, the opening ceremony of CardioCycle's headquarters base was grandly held in Phase V of Suzhou Biomedical Industrial Park.This TimeThe headquarters base located in Phase V of Suzhou Biomedical Industrial Park, which has been activated, covers an area of 3,200 square meters. The main products include embolic microspheres, various balloons, catheters, sheaths, etc.Currently, the company has 12 projects and products advancing simultaneously., all products have full independent intellectual property rights.