Nitinol wire frame coated with Titanium Nitride (TiN)

Decrease the dissolution of nickel ion efficiently, expected safe long-term biocompatibility.

Promote the growth of endothelial tissue, lessen thrombus complication.

Superior superelastic, effectively reduce atrioventricular block occurrence.

Nickel ion concentration in whole blood                                  Nickel ion concentration in endocardium

D.Y. Zhang, W.J. Zeng, Z.J. Zi, and P.K. Chu, Fabrication of graded TiN coatings on nitinol occluders and effects on in vivo nickel release, Materials Science and Engineering C. 29 (2009), 1599-1603.

Cera Animal Study: Compared to Nitinol occluder, the Cera occluder have demonstrated that faster and better growth of endothelial cell and lower risk of thrombus formation. 

Strategic Membrane Selection

The ASD/PFO covered by a PET membrane that minimizes the chance of clot formation and has a small volume to get into lower profile sheath.

The VSD/PDA occluder covered with a PTFE membrane, which has a denser structure suited for high pressure defect.

Conform anatomical features of the defect, providing optimal design

3 types of peri-membranous VSD and a muscular VSD devices designed for different kind of VSD.

The ASD waist diameter available ranging from 6 to 42 mm, and the PDA occluder ranging from 0406 to 2224.

PFO Occluder Device Information intended for Patients

Magnetic Resonance Imaging (MRI)

Ø  A patient with an implanted PFO Occluder 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 680 G/cm or less.

•      Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) at 2 W/kg for 15 minutes scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the occluder when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system.

In non-clinical testing, the device was determined to produce a temperature rise of less than 1.33 °C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.02 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.

Ø  Remark: MRI image quality may be compromised if the area of interest is in the exact 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 may be necessary.

Expected Lifetime of FPO Occluder

The PFO Occluder is a permanently implanted device. 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.

Follow-up

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.

At each visit, imaging such as CT scans will be carried out to determine the performance of the occluder. If you have poor kidney function, you should ask your doctor about the dyes used in some of these imaging studies, as they may be harmful.

Material/Substances in Contact with Patient

The overall qualitative and quantitative information on the materials and substances of implantable devices to which patients can be exposed are respectively shown in Table 1 and Table 2.

Table 1. Cera PFO Occluder Material Composition by weight

Table 2. CeraFlex PFO Occluder Material Composition by weight

During the intended use, heart (atrium), left superior pulmonary vein, femoral vein as well blood will come in contact with the device.

Note: If you have a history of metal allergies, you should ask your doctor. Your doctor will help you decide whether it is appropriate for you to get an occluder.

The occluders do not contain medicinal substances, animal or human tissue; they are no blood products and are not radioactive.

February 7, 2023, V1.0

Cera^TM PFO Occluder

Cera™ Clinical study in China:

Principal Investigator: Zhang Zhiwei, MD, FACC, Guangdong Cardiac Institute.

Evaluation of efficacy and safety of Cera™ septal defect occluder for congenital cardiac detect: A multicenter, randomized and controlled clinical trial.

- 11 medical centers，460 cases enrolled (231 Cera™, 229 HeartR™).

- Follow up endpoint： 1, 3, 6, 12 months.

Study Conclusion:

The success rate of immediate complete occlusion with Cera™ occluder is higher than 97.8%.

The results showed that the incidence of residual shunt were relatively less.

The arrhythmia incidence in Cera group is lower than that in HeartR group which as much as 36%.

Cera™ PM-VSD clinical study in Brazil:

Principal Investigator: Doctor Raul Arrieta and tutored by Doctor Carlos Pedra.

Prospective, multicenter, non randomized study.

Starting on November 2010.

3 Brazilian institutions, 56 patients.

Follow up endpoint: 1, 3, 6, 12 and 24 months.

Initial Result:

The percutaneous closure of peri-membranous ventricular septal defect with Cera™ Device has showed a safe effect with excellent immediate occlusion and low complication.