Deep Dive | Analysis Report on Innovative Medical Devices (Stents)

The venous stent system consists of a self-expanding nickel-titanium alloy stent and a delivery system. The self-expanding stent is woven from nitinol wires, providing flexibility, fracture resistance, and fatigue durability. The product features a unique self-compensating release structure, ensuring stable and precise stent deployment during surgery. It also has a retraction function that allows 90% of the stent length to be retrieved back into the delivery system if the stent is not fully deployed, enabling repositioning and addressing any deployment anomalies, thus improving product safety.

This product is intended for use in the iliac vein to treat non-thrombotic iliac vein compression syndrome and post-thrombotic syndrome.

Product Structure and Composition:

1. Closed-ended large-diameter nickel-titanium alloy wire seamless woven stent, offering excellent flexibility and mechanical safety.

2. Designed to accommodate the high curvature of the iliac vein, with three variations to suit different anatomical structures.

3. The patented delivery system ensures uniform stent deployment and has a retraction ability of over 90% for retrieval and re-deployment.

Product Scope:

This product is intended for use in the iliac vein to treat non-thrombotic iliac vein compression syndrome and post-thrombotic syndrome.

Operating Principle:

The woven stent is pre-assembled inside the delivery system's outer sheath. The stent system is inserted into the human blood vessels through the vascular puncture site. When reaching the diseased area, the inner tube is advanced while retracting the outer sheath of the delivery system, allowing the stent to compensate and accurately position itself in the diseased area. The stent self-expands to widen the narrowed vessel, permanently staying within the blood vessel to establish blood flow.

Product Expansion:

In 2019, the Inno-Xmart venous stent system, an innovative invention, obtained green channel approval for innovation from the China Food and Drug Administration (CFDA). Clinical trials were conducted in 18 hospitals nationwide, with outstanding clinical follow-up data and unanimous praise from experts. On July 28, 2023, the Inno-Xmart venous stent system received official approval, becoming China's first registered nickel-titanium alloy woven iliac vein stent under Class III medical device registration. This product is classified as a Class III medical device, which signifies high risk and requires strict control and management measures to ensure its safety and effectiveness. Inno-Xmart venous stent system is mainly used in the iliac vein for the treatment of symptomatic venous obstruction. All 193 clinical trials have been completed, with a patency rate of up to 96.07%, demonstrating superior clinical performance compared to internationally marketed products.

Patent Technology Analysis:

A seamless stent and its manufacturing method are disclosed, designed for intravascular intervention. It consists of at least one woven wire with an even number of free ends. The free ends of the woven wire are paired and seamlessly joined to form a cylindrical structure, with a diameter identical to that of the woven wire, through the seamless connection of the cutting parts of the two free ends, forming an outer sleeve with a connecting tube on its inner wall, seamlessly connected to the outer wall of the joined part. This seamless stent has the seamless connection of the joined part of the free ends to the connecting tube. The same diameter of the joined part as the woven wire reduces the diameter of the joined part, allowing uniform distribution of radial and axial forces on the free ends. The cutting parts of the free ends increase the contact area between the free ends, facilitating laser welding. The seamless stent exhibits excellent flexibility and aesthetic appeal.

A self-expanding stent delivery system and its gear drive components are disclosed. In one embodiment, the guiding component for the delivery system can include an inner tube and an outer tube, with the outer tube partially covering the inner tube. The inner and outer tubes are configured to move relative to each other along the axial direction, creating a stent loading area between the inner wall of the outer tube and the outer wall of the inner tube, which is in a contracted state. The gear drive components include coaxially arranged first and second gears. The first gear is connected to the outer tube through a first rack, while the second gear is connected to the inner tube through a second rack. Rotating the first and second gears drives the simultaneous movement of the outer and inner tubes along the axial direction. Such a delivery system can drive the reverse motion of the outer and inner tubes simultaneously, allowing precise control of their speeds and addressing the issue of inaccurate stent deployment caused by stent shortening.