PHYSICIAN CONTENT – PRE-CE MARK/CLINICAL TRIAL STAGE
This webpage includes information derived from the Instructions for Use for Healthcare Professionals.
The Allay® Aortic Stent is an investigational device not yet registered in any countries for use in aortic dissection. You may need the information provided here to take care of patient currently or previously enrolled in a clinical study evaluating the Allay® Aortic Stent in Aortic Dissection. The patient you are treating will have been implanted with an Allay® Aortic Stent as investigational device in such a study.
If you have additional questions, please contact Intressa Vascular at support@intressavascular.com or ask the patient for his/her patient ID card with details on the Clinical trial site and contacts.
The Allay® Aortic Stent
MRI safety and compatibility
Non-clinical testing has demonstrated that the Allay® Aortic Stent implant is MR conditional as defined in ASTM F2503.
A patient with this device may be safely scanned after implantation under the following conditions:
- Static magnetic field of 1.5 Tesla or 3.0 Tesla only,
- Maximum spatial gradient field of 2000 Gauss/cm,
- Patients with Allay® Aortic Stent implants may be scanned for up to 1 hour in Normal Operating Mode at 1.5 T and 3 T,
- Patients with Allay® Aortic Stent implants may be scanned without landmark restrictions.
The presence of Allay® Aortic Stent implants may produce an image artifact of 3.4 cm. Some manipulation of scan parameters may be needed to compensate for the artifact.
The safety of the Allay® Aortic Stent implants during scanning has not been proven if there is another type of implant within 2 cm.
When the Allay® Aortic Stent is used in combination with stent grafts, the most conservative MRI parameters between the Allay® Aortic Stent and the other endoprosthesis should be used to restrict MR scan conditions.
Other
If you have additional questions, please contact Intressa Vascular at support@intressavascular.com or ask the patient for his/her patient ID card with details on the Clinical trial site and contacts.
Contact
For more information on Intressa Vascular or the Allay Aortic Stent, please provide your contact information.
