Venous Stent for CVD in Nickel-Titanium Alloy Wire

Company Profile

Suzhou Innomed Medical Device Co., Ltd was founded in January 2013, and is a high-tech enterprise specializing in the research and development and manufacturing of innovative cardiovascular and cerebrovascular implantable medical devices and interventional high-end consumables.


The company was founded by Dr. XIAOYAN SHAWN GONG, a talented person introduced by the National Major Entrepreneurial Talent Program, and has a strong technical team recognized in the industry, with profound R&D experience in the field of medical device manufacturing for cardiovascular, neurological and structural heart diseases. The company has many product development projects, including cardiology, cardiac surgery, vascular surgery and other multidisciplinary fields, and has built three major technology platforms: vascular intervention, vascular implantation and structural heart disease. The peripheral vascular stents and venous stents under development have been granted the "green channel" for special approval of national innovative medical devices. At present, the company has 6 overseas doctors, 12 masters and nearly 100 employees, and has built a professional production center with 10,000-grade clean plant, R&D and office, covering an area of over 10,000 square meters, and has passed ISO13485 quality management system certification. The company has obtained three NMPA national class III medical device registrations including guidewires and contrast guidewires, and two class II medical device registrations. Several products have obtained 510k certification in USA and CE certification in EU, and entered many countries including Poland, Athens and Latvia. Meanwhile, the company has reached a good long-term cooperation with many famous universities, enterprises and hospitals at home and abroad. The company is currently applying for nearly 100 patents, many of which have entered Europe and the United States.


In 2017, the company was awarded as a national high-tech enterprise, and in 2019, it was awarded as one of the top 10 medical device solution providers in Asia Pacific by Outlook Medtech. With market and R&D as the driving force to move forward, Innomed Medical has built a technological innovation platform and continuously launched innovative medical devices with independent intellectual property rights.

Product Description                      
The fatigue-resistant nickel-titanium wire braided Inno-Xmart iliac vein stent system is mainly used in the iliofemoral vein for the treatment of symptomatic venous obstruction. Through the development of unique braided structure, delivery system, positioning technology, and surface treatment technology, we have solved the key technical problems such as inadequate venous support of the iliac vein, poor flexibility and fatigue performance, mismatch between the designed structure and the anatomical structure of the iliac vein, difficulty in surface treatment of the braided stent, and shortening when the stent is released, and developed an iliac vein stent with excellent flexibility, fracture resistance, contrast and fatigue resistance. It is more suitable for iliac vein stenosis and occlusion, and has better folding resistance and flexibility compared with the traditional laser-cut stent.

Principle of Operation
The stent compresses in diameter to reach the lesion through the vascular lumen and then radially dilates the stenosed vessel at the lesion and positions it at the lesion to permanently establish vascular access at the lesion. The stent system is seamlessly braided with nickel-titanium alloy wire, and the stent is pre-assembled into the outer sheath of the delivery system; the stent system enters the human blood vessel from the vascular puncture site; when it enters the lesion area, the inner tube is advanced at the same time by retracting the outer sheath of the delivery system to compensate for the shortening of the stent, so that the stent is accurately positioned at the lesion site. The stent is then permanently retained in the body by self-expanding to establish blood flow pathways and withdraws from the delivery system. In the event of an abnormality during release, 90% of the released stent length can be retrieved and re-released.

Core Technology
(1) For woven bracket.
Radial force>0.1N/mm;
Stent with high resistance to bending, bending 180 ° pipe cavity intact without folding;
Bending fatigue test 10 million times without fracture;
Twisting fatigue test 10 million times without fracture;
Radial fatigue test 380 million times without fracture;
Flat plate pressure test 10 million times without fracture.
(2) Stent conveyor.
The repositioning and re-release function can be realized, and 90% of the released length of the stent can be recovered and re-released.
The conveyor has self-compensation function to ensure accurate stent positioning and uniform release.

Innovation Point
The fatigue-resistant nickel-titanium wire braided Inno-Xmart Iliac Vein Stent System is mainly used in the iliofemoral vein for the treatment of symptomatic venous obstruction. Compared with the traditional laser-cut stent, this product has better fracture resistance and flexibility, and can withstand repeated loads on the stent after implantation from large deformations such as twisting, bending and compression of the vessel caused by limb movements.

The Innovations Are.
(1) The excellent flexibility and folding resistance of the seamless braided stent of nickel-titanium alloy wire is an important innovation of our venous stent, which can better adapt to the shape of blood vessels and reduce the stimulation of blood vessels in clinical application, and has excellent flexibility, folding resistance and strong fatigue resistance compared with similar products.
(2) The stent release system has a unique self-compensating structure to ensure stable and accurate stent release pattern during surgery.
(3) High-precision repositioning of the venous stent system: when the stent is not completely pushed out of the delivery system, 90% of the stent length can be recovered back into the delivery system and repositioned for release, which can solve the abnormalities in the stent release process and improve the safety of the product.
(4) Special surface treatment process to improve the corrosion resistance of the stent.
(5) Good developing effect, the developing filament running through the barrel of the stent is clearly visible under the X-ray equipment and precisely positioned.

Product Advantage
1.Braided by NITI wires, excellent flexibility, fracture resistance and fatigue resistance.
2.Flower ends, adapt to the anatomy of the iliac vein.
3.Excellent radiopacity.
4.High crush resistance.

Delivery System Features
1.Unique "self-compensating"mechanism, to ensure stent precise positioning.
2.Re-location function, can retract more than 90% stents.
3.Easy to operate, release the stent by rotating hand wheel.

Thrombus Aspiration Catheter Design Features
1. High-speed rotating shaft for thrombus crushing, suction and delivery.
2. Funnel shaped basket blocks the thrombus and guides it into the catheter.
3. Woven mesh basket can adapt to different sizes and structures of blood vessels.
4. One-piece design for easy handling.
5. Transparent viewing window with head for easy observation of clot extraction.

Heparin Coated Stent Design Features
1. The head end is beveled and flared (one-piece weave) to facilitate stent positioning and anchoring, and the stent flare opens and pulls the delivery device to achieve positioning. The beveled surface is compatible with the blood vessels at the bifurcation.
2. The stent is composed of two parts: densely woven section and sparsely woven section, with the densely woven section forming a better support for the compression area and the sparsely woven section reducing the stimulation to the distal vessels.
3. Heparin coating on the surface of the stent reduces the formation of thrombus.

Warning
1. This product is sterile, has been sterilized with ethylene oxide, and is designed for single use. It should not be reprocessed for use, sterilized or re-sterilized after use.
2. People allergic to nickel or titanium (Nitinol) may have an allergic reaction when implanted with this product.
3. Do not use if the package is found to be open, broken, leaking or beyond the sterilization expiration date before use.
4. The guidewire must be threaded through the tip of the delivery system before the release of the stent can begin.
5. The delivery system must not come into contact with organic solvents, such as alcohol, etc.
6. Do not use this device with contralateral access.
7. Avoid placing the stent in a position where it may block the opening of an important collateral vessel.
8. Stent implantation may cause difficulties in future diagnostic or therapeutic procedures.
9. Stent implantation may cause thrombosis, distal embolism, and stent displacement.
10. Placing multiple stents that overlap each other at the site of the lesion may increase the risk of stent fracture.
11. After use, the product is disposed of according to the standard disposal procedures for single-use medical devices in medical institutions.

Scope of Application
This product is intended for use in the iliofemoral vein and is indicated for obstruction of the vein.

Contraindications
Contraindications to percutaneous transluminal angioplasty (PTA) in general are also contraindications to stent placement. These contraindications include, but may not be limited to, the following conditions.
1. Patients with renal insufficiency who, in the opinion of the physician, will experience deterioration in renal function with the use of contrast media.
2. Patients during pregnancy.
3. Patients with bleeding disorders or those who are unable to receive anticoagulation or antiplatelet aggregation therapy.
4. Patients in whom vascular perforation has occurred as evidenced by leakage of contrast medium.

Caution
1. This device should be used by physicians trained in appropriate interventional techniques such as percutaneous transluminal angioplasty and endovascular stent placement.
2. When catheters are located in the patient, they should always be operated under X-ray.
3. Radiographic equipment that provides high quality images is required.
When implanting multiple stents, the proximal stent should be implanted first, followed by the distal stent. When stents are implanted in this order, there is no need to cross-over to deliver stents and the possibility of displacement of implanted stents is reduced.
5. Great care must be taken when passing a partially or fully released stent with an assist device.
6. Dispose of the used product according to the standard disposal procedures for single-use medical devices in medical institutions.

Storage
The intravenous stent system should be stored at room temperature in a clean, well-ventilated environment free of corrosive gases.

Production Date/Use Period
Under storage conditions, the product is valid for three years.
See the product label for details of production date and expiration date.

Disclaimer
Ltd. expressly states that the intravenous stent system manufactured by our company is for single use and should not be reused. Ltd. will not be held responsible for any damage to the product or failure of the procedure due to improper selection of product specifications, incorrect operation or any other man-made accidents.

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