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The Ankura™ Thoracic Stent Graft is specifically designed for endovascular treatment of thoracic aortic dissection, aneurysm and other relative diseases. It reinforces the vascular wall of thoracic aorta from rupture.

Optimal Proximal Bare Stent

•Allow for deployment across the LSA or LCCA without occluding the blood flow

•Provide extended Proximal Landing Zone

•Less traumatic to the aortic branches

Proximal Sealing and Fixation

•MINI Wave - Enhanced apposition to the aortic wall

•Decreased endoleak risk

•Migration resistant

Greater Flexibility

•Conform to the natural curvature of thoracic aorta

•Reduce the possibility of kinking

•4mm, 6mm and 8mm taper available

Other Strengths

•Self-expanding Nitinol stent – Radial force fixation

•No suture on the main body – Avoid pinhole leakage ( Type Ⅳ endoleak)

•Longitudinal supporting strut on the greater curvature – Avoid stent shortening, provide axial support

•e-PTFE Dual Membrane – Excellent biocompatibility and durability

•Kink-resistant delivery system with Hydrophilic Coating

Information intended for Patients

Magnetic Resonance Imaging (MRI)

A patient after being implanted with the Ankura Stent Graft can be safe to have MRI procedure under the following conditions:

- Static magnetic field of 3.0 Tesla or less

- Spatial gradient filed of ≤720Gauss/cm

- Maximum whole-body-averaged specific absorption rate (SAR) of 2W/kg for 15 minutes of scanning

Expected lifetime of Ankura Device

The Ankura Stent Graft 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 doctor’s professional judgment. Lifetech evaluated the durability and integrity of the implanted device. After 10 years simulated physiological loading of 380 million cycles of the implanted device, tested samples were examined visually under 3D microscope with magnification (20x). There was no evidence of Nitinol wire pitting or cracking, nor of fatigue related fractures. The device was intact after 10 years simulated in vivo physiological loading of 380 million cycles, and no perforation or detachment of the ePTFE graft as a result of pulsatile fatigue test. Based on the durability and integrity testing results, it can be stated that the expected lifetime of the device is at least 10 years.

Follow up

It is important to schedule regular follow-up visits with your doctor. Follow-up visit will help the doctor to check your aneurysm/dissection and stent graft on a regular basis. The follow up visit should be performed at 24 hours, 1, 3, 6, 12 and 24 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 stent graft. 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 materials and substances to which the patient can be exposed in the implantable device (in wt.%) are NiTi (Nickel titanium, 49-67%), stainless steel (7-17%), PtIr (Platinum-Iridium, 0.5-6%), PTFE (Polytetrafluoroethylene, 20-40%), PP(Polypropylene,<1%). During the intended use, the thoracic aorta, abdominal aorta, iliac artery, femoral artery as well the 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 Ankura stent graft.

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

Document No: LT-TS-12IC V1.0 / 2022.09.08

Ankura^TM TAA Stent Graft Product Specification