Complaint
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 Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped per standard technique. The distal tip is visible under X-ray to assist the physician with the position and movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE which reduces friction of the wire.
Product Advantage
1. Excellent pushability and torsional control.
2. Stable hydrophilic coating on the surface, which can move freely in the blood vessel.
3. Shaping ribbon design allows the product to be repeatedly shaped according to the doctor's needs.
4. Unique spring design at the head end for accurate positioning.
Product structure
This product is composed of core wire, safety wire, winding wire and hai wave tube. The core wire is divided into proximal core wire and distal core wire, which are connected by the wave tube; Winding is divided into proximal winding and distal winding. The guide wire is coated with a PTFE coating on the proximal end and a hydrophilic coating at the distal end. Proximal core wire, safety wire, proximal winding wire is 304 stainless steel; The distal core wire and the wave tube are nitinol alloys; The distal winding is a platinum-tungsten alloy; The guide wire is supplied with a twist control device. The product is sterilized by ethylene oxide for single use. Shelf life is 2 years.
Scope of application
This product is used to guide the catheter into the blood vessel and localization, not for neurovascular use.
Product Performance
This product is a stainless steel/nitinol guide wire with a variety of different usable lengths and diameters. The head end part is plastic, and the head end can be molded into a "J" shape before use. The guide wire guides and supports the catheter, helping the catheter to enter the blood vessel and guide the catheter to the lesion site smoothly; The guide wire is visible under the X-ray device, and the doctor can judge the movement of the guide wire according to its visibility. For technical parameters of the product, please refer to the product label (e.g. length, diameter of the guide wire).
Device Specification
The Inno-Pathwire guidewires has three models. Refer to the product label for product specifications (e.g., wire length, diameter, length of tip radiopacity, and shaft stiffness).
| Model specifications | Outside diameter | Head end grams | Length | Support |
| IW-14-190-STS | 0.014" | 0.6g | 190cm | Supple |
| IW-14-190-MDS | 0.014" | 0.6g | 190cm | Moderate |
| IW-14-190-EXS | 0.014" | 0.6g | 190cm | Hardness |
| IW-18-300-MDS | 0.014" | 0.8g | 300cm | Moderate |
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.
Cautions
1. This Inno-Pathwire should be used only by physicians trained in angiography and Percutaneous Transluminal Coronary Angioplasty (PTCA), and/or Percutaneous Transluminal Angioplasty (PTA).
2. Refer to the instructions supplied with the interventional devices to be used with the Inno-Pathwire for their intended uses, contraindications, and potential complications.
3. Do not use if the package is open or damaged.
4. Do not use if it is expired.
Directions for use
1. Carefully insert the guide wire through the guide wire lumen hub of the interventional device.
2. Advance the guide wire until its tip is just proximal to the interventional device tip.
3. If using a guiding catheter, engage the guiding catheter and insert the interventional device/ guide wire assembly through the hemostatic valve. Advance the system through the guiding catheter until it is just proximal to the tip of the guiding catheter.
4. Tighten the hemostatic valve to create a seal around the interventional device. Ensure intentional guide wire movement is still permitted.
5. Attach the torque device to the guide wire, if desired.
6. Under fluoroscopy, advance the guide wire out of the interventional device while securing the interventional device in place. Use the torque device to steer the guide wire across the lesion.
7. Secure the guide wire in place while tracking the interventional device over it and to the target lesion.
8. If a different tip configuration or guide wire is indicated, carefully remove the guide wire while observing guide wire movement under fluoroscopy.
9. Reshape the guide wire tip according to standard practice or prepare another guide wire to be used.
10. Reinsert the guide wire following Steps 1 through 7 of this section.
Brochure
Certificate
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