Recommendations about transitional coverage of medical devices in France in July 2022

Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a newly established pathway to obtain coverage for CE-marked medical devices intended for the treatment of rare or serious diseases or compensation for a disability. The transitional coverage is provided for 12 months with an opportunity for renewal before applying for full-time inclusion in the List of Reimbursable Products and Services (LPPR).

In July 2022, the French National Authority for Health (HAS) released new recommendations about transitional coverage of medical devices and medical aids from the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) meetings.

Two positive opinions of the following devices were published:

• Chyme reinfusion system THE INSIDES SYSTEM by THE INSIDES COMPANY for treatment of bowel failure with enterostomy or fistula (link);
• Renal denervation catheter SYMPLICITY SPYRAL by MEDTRONIC for treatment of resistant hypertension (RH) (link).

Two negative opinions of the following devices were published:

• Mitral contour system CARILLON by CARDIAC DIMENSIONS EUROPE GMBH for treatment of severe functional mitral insufficiency (link);
• Device for percutaneous arterialization of the deep venous network LIMFLOW SYSTEM by LIMFLOW for treatment of chronic limb-threatening ischemia (CLTI) (link).

See the details in French here.

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