Inno-Spring Peripheral Stent System with CE Certificate

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
Peripheral artery stents are mainly used to treat stenosis or occlusion of peripheral arteries such as iliac artery, femoral artery arteries, subclavian arteries, and renal arteries to restore blood supply to the distal. The stent is used to restore blood supply to the distal vessels. Because stents are subject to significant deformation, the greatest problem facing self-expanding stents in lower extremity arteries is the susceptibility to fatigue rupture. Therefore, for the superficial femoral artery, it is recommended to implant a nickel-titanium stent with high fatigue resistance. The most important problem with self-expanding stents in lower limb arteries is the susceptibility to fatigue rupture.

Product Advantage
1. Uniquely Designed Seamless Knitting Stent with Closed Ends.
2. Eliminate the Stress Concentration Inherent to Laser Cut Stent to Prevent in vivo Fractures.
3. Uniform Biomechanical Properties Close to Native Artery along Stent Length for Better Performance.
4. Use of Radiopaque Material to Enhance the Visibility under Xray.

Product Specifications

Scope of Application
Peripheral stent vascular systems are mainly used in peripheral vascular disease in which the aorta and its branches other than the coronary arteries are stenosed or occluded or have dilated flow. At present, the most commonly used interventional treatment method at home and abroad is stenting, and the types of stents include metal stents and drug-carrying stents. The development project of our peripheral vascular stent system, on the other hand, is based on a seamlessly woven stent of nickel-titanium alloy wire with drug loading. And the developing wire running through the entire stent body makes the stent clearly visible under X-ray during the surgical implantation process. Inno-Spring is used to treat autochthonous or occluded lesions of primary or restenosis of the superficial femoral artery and/or proximal popliteal artery up to a total length of 200 mm, with reference vessel diameters from 4 mm to 8 mm.

Product Clinical Requirements
1. For trans-knee vessels with the highest demand for stenting mechanical properties.
2. To fill the gap in the treatment of trans-knee popliteal artery lesions in China and abroad.
3. Reduce the probability of stent fracture.
4. Meet the requirements for stent use across the knee joint.

Product Technical Highlights
The first stent product for the treatment of arterial stenosis or occlusive lesions involving the trans-knee joint.
1. seamlessly woven from nickel-titanium alloy wire
2. Special surface treatment process
3. ergonomic design
4. one-handed operation
5. gradual push to release the stent

Product Innovation Points
It has passed the CFDA special approval for innovative medical devices.
1. A bionic stent that matches the mechanical properties of the blood vessel.
2. Optimal adaptation to the radial support, suppleness of the femoropopliteal artery.
3. Excellent fracture resistance, fatigue resistance.

Product Structure
(1) Inner and outer tube gap cleaning ports
(2) Thumb drive
(3) Safety knob
(4) Blocking knob
(5) Inner tube cleaning port
(6) Tip
(7) Outer tube

Steps to Use
1. Cleaning. Unscrew the luer connector to expose the cleaning port and inject heparin-saline through the inner and outer tube gap cleaning port and the inner tube cleaning port respectively to clean the stent system until cleaning fluid flows from the distal end.
2. Introduce. Insert an adapted 0.018" guidewire through the Tip at the distal end of the stent system into the inner lumen of the conveyor until the guidewire is exposed from the end of the handle. Secure the guidewire and slowly feed the delivery system into the lesion along the guidewire. The proximal and distal visualisation marks of the outer tube of the delivery system cover the extent of the target lesion and are each 10mm beyond.
3. Unlock. The safety knob is unlocked by turning it counterclockwise and the safety knob pops up to indicate that the thumb drive has been unlocked.
4. Start the release. Push the thumb drive to initially spread the stent in the vessel. Stent pushing is stopped when a flower shape appears, the initial position of the distal end of the stent is assessed and minor local adjustments to stent positioning are made.
5. Complete release. Slowly push and retract the thumb drive, repeatedly, until no resistance to pushing the thumb drive is felt as the stent approaches full release, at which point the blocking knob can be opened. The thumb drive can be pushed to the bottom and the stent confirmed to be fully released under x-ray. Note: Do not restrict the setback of the outer tube of the delivery system when releasing.
6. Withdrawal. Withdraw the thumb drive back to the initial position and the tip head back into the sheath. Turn the safety knob and blocking knob clockwise to lock the thumb drive. Withdraw the delivery system safely from the vessel along the guidewire.

Storage and Transportation Conditions
The product is stored in an environment of normal temperature, clean, good ventilation and no corrosive gas, avoiding direct sunlight and avoiding storage in abnormal temperature and high humidity environment.

Brochure

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