Publications by authors named "Marie-Christine Reymond"
FACTORS INFLUENCING REIMBURSEMENT OF MEDICAL DEVICES IN FRANCE.
Int J Technol Assess Health Care
December 2016
Article Synopsis
- - The study analyzes factors influencing the reimbursement application process for medical devices (MD) in France, particularly through the National Committee for the Evaluation of Medical Devices (CNEDiMTS) and the list of products qualifying for reimbursement (LPPR).
- - Researchers reviewed a total of 151 appraisals from 2011 and 2012, finding that 62% were deemed to have sufficient expected benefit (EB), with higher success linked to compliance with technical standards and prior favorable opinions.
- - The findings emphasize the importance for manufacturers to meet health authority expectations by providing high-quality evidence and adhering to technical norms to improve their chances of receiving reimbursement.
Objective: Heart failure with preserved ejection fraction (HFpEF) is characterized by elevated left atrial pressure during rest and/or exercise. The Reduce LAP-HF (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) trial will evaluate the safety and performance of the Interatrial Shunt Device (IASD) System II, designed to directly reduce elevated left atrial pressure, in patients with HFpEF.
Methods: The Reduce LAP-HF Trial is a prospective, nonrandomized, open-label trial to evaluate a novel device that creates a small permanent shunt at the level of the atria.