#SFHS2616271AFrance updates reimbursement conditions for the EDWARDS PASCAL PRECISION mitral valve repair system
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This order changes the reimbursement listing for the EDWARDS PASCAL PRECISION transcatheter mitral valve repair system in France. It sets clearer covered indications for patients with severe primary or secondary mitral regurgitation who remain symptomatic despite optimal medical care and are not eligible for valve surgery. Hospitals and heart teams must confirm clinical and echocardiographic eligibility through a multidisciplinary review. Patients with life expectancy under one year because of non-cardiac conditions are excluded, and the order also updates covered product references and points users to the existing rules for prescribing and using the device.
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Key Changes
- Updates the reimbursed indications for EDWARDS PASCAL PRECISION in primary and secondary mitral regurgitation
- Requires multidisciplinary validation of clinical and echocardiographic eligibility
- Updates covered product references for reimbursement codes 3115790 and 3149300
Obligations
What this law requires
Use the EDWARDS PASCAL PRECISION mitral repair system for primary mitral regurgitation only in patients with severe degenerative primary mitral regurgitation who remain symptomatic despite optimal medical management, are not eligible for surgical valve repair or replacement, and meet echocardiographic eligibility criteria.
Validate all eligibility criteria for primary mitral regurgitation, especially the surgical contraindication, through an ad hoc multidisciplinary team before using the EDWARDS PASCAL PRECISION device.
Do not use the EDWARDS PASCAL PRECISION device in patients whose life expectancy is less than one year due to extracardiac comorbidities.
Use the EDWARDS PASCAL PRECISION device for secondary mitral regurgitation only in patients with grade 3+/4+ secondary mitral regurgitation who remain symptomatic despite optimal medical management and are not eligible for surgical valve repair or replacement.
For secondary mitral regurgitation, confirm that the patient had a hospitalization for heart failure within the 12 months preceding the intervention before using the EDWARDS PASCAL PRECISION device.