Under Health Canada's special access guidelines, devices can be sold but the provinces control health spending so it's up to them or the private insurer if the patient has a supplemental plan to reimburse the company. Or of course whether Anteris wants to charge for the device.
Canada's Special Access Program is like expanded access (also called compassionate use) in the US and not a blanket approval like a Humanitarian Device Exemption. Each use under special access has to be requested by a health care professional and a month's worth of devices can be requested if shipping will cause delays in getting the devices.
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