Your Personalised Implant Card
The purpose of a patient implant card is to:
· enable the patient to identify the implanted device and to get access to other information related to the implanted device
· enable the patient to identify themselves as persons requiring special care in relevant situations
· inform emergency clinical staff or first responders about special care relevant to the patient in emergency situations
The patient implant card will be completed by the healthcare institution/provider prior to providing the card to the patient.
|Patient Implant Card - Front||Symbol Definitions |
|Patient Implant Card - Back ||Example of Device Label |
Non-clinical testing has demonstrated that the Aorfix™ Stent Graft and Altura Endograft implants are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:
Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T).
Maximum spatial gradient field less than or equal to 10 T/m.
Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:
2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T.
2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T.
Expected lifetime of the device
The device is a permanent implant. The lifetime of the device is determined by the life of the patient into whom it is implanted.
Independent clinical studies have shown equivalent patient outcomes between stent-graft and open surgical treatment of AAA patients at the age of 60 and as a result, Lombard Medical Ltd does not recommend the use of the device in those of less than 60 years.
Warnings and contraindications
Lombard Medical’s AAA stent graft medical devices should not be used for:
· patients who have a condition that threatens to infect the graft
· patients with known allergies or sensitivities to the implant materials (including polyester, nitinol, and tantalum)