BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.
Provision of a signed, written and dated informed consent or non-opposition (where applicable)
Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)
Contra-indications of each device as described in the instructions for use.
The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.
Cohort
Other
BALT medical devices
DeviceIncludes, but is not limited to, the following: * Access devices * Aneurysm treatment devices * Ischemic Stroke and peripheral occlusive diseases treatment devices * Arterio-Venous Malformations/fistulas treatment devices
Rate of occurrence of device-specific safety indicator(s).
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of devices achieving its intended use.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of devices achieving its specific performance indicator(s).
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
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