HeartR - Model ASD - Occluder

Magnetic Resonance Imaging (MRI)

A patient after being implanted with the ASD Occluder can be safe to have MRI procedure under the following conditions:

• Static magnetic field of 3.0 Tesla or less
• Spatial gradient filed of ≤680Gauss/cm
• Maximum whole-body-averaged specific absorption rate (SAR) of 2W/kg for 15 minutes of scanning

Expected Lifetime of ASD Occluder Device

The ASD 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.

Material/Substances in Contact with Patient

The Occluder implants are composed of

• NiTi (80%-95%), stainless (2%-20%), PA (0.1%-0.8%), PET (1.2%-8.9%) in HeartR ASD occluder;
• NiTi (80%-95%), TiN (~0%), stainless (2%-20%), PA (0.1%-0.8%) and PET (1.2%-8.9%) in Cera ASD occluder;
• NiTi (85%-98%), TiN (~0%), PA (0.2%-1%), PET (2%-15%) in Ceraflex ASD occluder.

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.