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Recommendations about transitional coverage of medical devices in France in January 2023
Transitional coverage of certain products and services (prise en charge (PEC) transitoire), according to article L165-1-5 of the Social Security, is a pathway to obtain temporary reimbursement for CE-marked, presumably innovative medical devices intended for the treatment of rare or serious diseases or compensation for a disability. This mechanism allows reimbursement of medical devices for one year (with a possibility of renewal), with the goal of establishing additional evidence, before submitting an application for regular reimbursement via the List of Reimbursable Products and Services (LPPR).
In January 2023, 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:
- Intermittent coronary venous sinus occlusion system PICSO by MIRACOR MEDICAL with the following indication: secondary prevention of complications of anterior myocardial infarction with ST-segment elevation by reducing the size of the infarction in patients over 18 years of age with the onset of symptoms within the last 12 hours and a Thrombolysis in Myocardial Infarction (TIMI) flow of 0 or 1, in which percutaneous coronary intervention (PCI) is considered (link);
- Aspiration/extraction system FLOWTRIEVER SYSTEM consisting of TRIEVER catheter and FLOWTRIEVER catheter by INARI with the following indication: treatment of pulmonary embolism in combination with anticoagulant therapy for patients with severe pulmonary embolism, at high risk of premature death in failure or contraindicated to thrombolysis, or at high intermediate risk of premature death with hemodynamic deterioration despite well-conducted anticoagulant treatment, in failure or contraindicated to thrombolysis, when surgical embolectomy is not possible and after advice from a multidisciplinary team (link).
See the details in French here.
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