Easy and Precise Deployment
Micro screw connection
Available in Various Sizes Range
Can be used for various vessel lesions
Magnetic Resonance (MR) conditional
▶ Non-clinical testing showed that a patient with an implanted plug can be scanned safely immediately after placement of the device under the following conditions:
● Static magnetic field of 3 T or less.
● Spatial gradient magnetic field of 720s G/cm or less.
● Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning.
▶ Based on non-clinical testing, the device was determined to produce a temperature rise of less than 1.5 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.21 W/kg for 15 minutes of MR scanning. The maximum whole-body-averaged specific absorption rate (SAR) was derived by calculation and verified by calorimetry.
▶ MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device is necessary. The image artifact extends approximately 15 mm outside the device lumen when scanned in non-clinical testing using the spin echo sequence and gradient echo sequence, respectively in a 3.0 T Scanner with a whole body coil.
Material/Substances in Contact with Patient
The materials and substances to which the patient can be exposed in the implantable device (concentration in wt.%) are: NiTi (Nickel titanium, 54%-68%), stainless (9%-37%), TiN (Titanium Nitride, ~0%), PA (Polyamide, 0%-1%), PTFE (Polytetrafluoroethylene, 8%-23%).
The expected lifetime of the device, including data on implant survival rates:
The device is a permanently implanted device. A fatigue testing to simulate in vivo use of the device for 10 years was performed and the results are satisfied: the metal wire of vascular plug has no breaks or cracks, and the connection points of the metal wires are not loose, the plug is not migrated and its head is intact. Under normal circumstances, it will stay in the patient's body for life, unless it is required to be removed by the physician’s professional judgment. No special attention is needed by the patient.
It is important to schedule regular follow-up visits with your doctor. Follow-up visit will help the doctor to check your heart on a regular basis. The follow up visit should be performed at 24 hours, 1, 3, 6, and 12 months after the procedure, and can be adjusted by the doctor depending on your condition.
March 9, 2022, V1.0
CeraTM Vascular Plug System Product Specification
|Cat.No||Plug Diameter (mm)||Plug Length (mm)||Minimun ID per Cera VP size (Fr。)|