#SFHS2614197ABIOPROTEC arterial allograft added to France’s reimbursable medical products list
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
France adds BIOPROTEC’s refrigerated arterial allograft to the national list of reimbursable medical products. The product is a human-donor arterial graft kept between 2°C and 8°C, with a six-month shelf life from the date the arteries are collected. The reimbursement covers use in vascular bypass procedures in infected or high-infection-risk settings, and in replacing infected prostheses. For below-knee bypasses, it should be used only when the patient’s own saphenous vein is not suitable or cannot safely be harvested. Hospitals and vascular surgery teams will need to follow the listed ordering, storage, and operating-room use conditions.
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Key Changes
- Adds BIOPROTEC’s arterial allograft stored at 2°C to 8°C to France’s reimbursable medical products list
- Defines reimbursed uses for infected or high-infection-risk vascular bypass procedures and replacement of infected prostheses
- Sets practical use conditions, including vascular surgery team use, operating-room requirements, and limits for below-knee bypass cases
Obligations
What this law requires
Use the BIOPROTEC refrigerated arterial allograft only for reimbursed indications: vascular bypass in infected or high-infection-risk settings, or replacement of infected prostheses.
For below-knee bypass procedures, use the BIOPROTEC refrigerated arterial allograft only when the patient’s autologous saphenous vein is of insufficient quality or harvesting it is contraindicated due to the patient’s health condition.
Store the BIOPROTEC arterial allograft between +2°C and +8°C.
Do not use the BIOPROTEC refrigerated arterial allograft after its six-month shelf life, calculated from the date the arteries were collected.
Ensure the product is prescribed by the grafting surgeon within a vascular surgery team.