Innovative delivery system

360° flexible rotation, accurate positioning.

Pre-mounted delivery system, convenient operation.

lock/release mechanism, safe placement and detachment.

M.A. Astarcioglu, etc., Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure, Multicenter clinical experience, Herz. 2015 Apr;40(Supplement 2):146-150. Epub 2015 Feb 8.

Titanium Nitride coating technology

Prevent Nickel leaching.

Accelerate endothelialization and close defect rapidly. 

Soften Nitinol material and provide a more compliant and flexible implant.

Excellent braided structure

Offer potential benefits to decrease the chance of clot formation on the left atrial disc with braided technology instead of distal clamp.

Offer better adaptation in the interatrial septum with flexible disc.

Strategic Membrane Selection 

PTFE membrane was sewn into PDA devices to decrease residual shunt.

PET membrane was sewn into the ASD/PFO devices to get lower profile sheath.

ASD Occluder Device Information intended for Patients

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.

Document No: LT-TS-03IC V1.1 / 2022.12.08

CeraFlex^TM ASD Occluder