ISO&Nmpa Marked Innomed Intravascular Guide 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                      
A guide wire that is primarily used for TAVI and TEVAR procedures and has a variety of support and head size options.

Product advantage
A variety of tip design to meet the fixed needs of the guide wire in different fixed areas.
Different soft and hard design to meet the needs of different types of surgery.
Excellent supporting performance provides good support for conveying equipment.
The inner side of tip is provided with gold coil, which can be clearly seen under X-ray.
Body coated with PTFE coating, guide wireIt has excellentlubricity.
First-class conspicuousness, the inner winding wire is made of 99.99% gold wire winding, gold conspicuousness length 3cm.

Application range
It is suitable for guiding other instruments to be inserted into blood vessels, establishing percutaneous access to intravascular instruments, or conducting intravascular positioning, or establishing intravascular access. The product is not suitable for interventional diagnosis or treatment of coronary arteries and neurovascular operations.

Scope of application                     
For guiding the insertion of other instruments into the vessel, establishing percutaneous access to endovascular instruments, or for endovascular positioning, or establishing endovascular access.
 

Contraindications                     
Allergy to polytetrafluoroethylene (PTFE), 304 stainless steel, gold.
Not suitable for use in neurovascular vessels.

Product performance composition and structure
This product is mainly composed of core wire, outer winding wire, inner winding wire, PTFE coating. The core wire and outer winding wire are 304V stainless steel, and the inner winding wire is gold (Au). The product is sterilized by ethylene oxide and used once. Product shelf life of 3 years.

Scope of application
The product is suitable for guiding the insertion of other instruments into blood vessels, establishing percutaneous access to intravascular instruments, or for intravascular positioning, or establishing intravascular access. The product is not intended for use in coronary and neurovascular interventions for diagnostic or therapeutic procedures.

Introductions for use
1. Remove the protective coil with the guidewire from the package together. Do not use if the package is found to be opened or broken.    
2. Attach a syringe containing heparinized saline to the luer seat of the guidewire protection coil and inject it into the protective coil of the guidewire so that it fills the protective coil to moisten the guidewire.      
3. Remove the guidewire from the coil by pushing the exposed distal end of the guidewire until the proximal end of the guidewire is removed from the protective coil. When removing the guide wire from the coil, avoid gripping the head end of the guide wire to prevent damage to the wire. If the guidewire cannot be easily removed from the protective coil, re-inject an appropriate amount of heparinized saline into the protective coil and retry.    
4. Once the guidewire has been removed, do not reinsert it into the coil or reuse it.
5. Before use, inject heparinized saline into the catheter used to ensure that the guidewire can move smoothly through the catheter.
6. Carefully insert the distal cephalic end of the guidewire.
7. Advance the guidewire to the target site while keeping the catheter position fixed under x-ray fluoroscopy.
Note: Observe the movement of the guidewire within the vessel under X-ray fluoroscopy. Advance the guidewire only if the tip of the guidewire is visible under X-ray. During the operation, if resistance is felt or obstruction is detected by X-ray fluoroscopy, determine the cause and take appropriate measures to eliminate the resistance and avoid the risk of vascular perforation by carefully and slowly advancing or retracting the guidewire.
8. After positioning the guidewire safely, the treatment instrument is advanced to the target site.
9. The guidewire is withdrawn under the protection of the catheter.

Storage and transportation conditions
Store the product at room temperature, in a clean, well-ventilated environment without corrosive gases, avoid direct sunlight, and avoid storage in abnormal temperature and high humidity.

Got a question? Find our FAQs here.