EBR Systems Wins Forfait Innovation Package By French Ministry Of Social Affairs And Health

EBR Systems said that the College of the French National Authority for Health (Haute Autorite de Sante, HAS) awarded a Forfait Innovation Package for the company’s WiSE Cardiac Resynchronization Therapy (CRT) System.

The award, worth up to €1 million, will help treat as many as 40 patients and support the SOLVE CRT global clinical study. It has started enrolling heart failure patients in France at CHU Grenoble Alpes, APHM Hôpital de La Timone (Marseille), CHU Rennes – Pontchaillou and Clinique Pasteur (Toulouse). Patients are non-responders to, or unable to receive, conventional CRT.

About the size of a grain of rice, the WiSE CRT Electrode is being evaluated as part of the SOLVE CRT clinical study. The SOLVE CRT study is enrolling Heart Failure patients who have failed conventional cardiac resynchronization therapy.

About the size of a grain of rice, the WiSE CRT Electrode is being evaluated as part of the SOLVE CRT clinical study. The SOLVE CRT study is enrolling Heart Failure patients who have failed conventional cardiac resynchronization therapy.

The Forfait Innovation funding mechanism was established by the Ministry of Social Affairs and Health to fast track the provision of innovative healthcare technologies to French patients, while collecting data to support a longer-term reimbursement decision. This funding is only awarded to select medical technologies that demonstrate breakthrough innovation and hold potential for significant clinical benefits.

The CE Mark-approved WiSE CRT system is the first and only implantable cardiology device to receive this innovation funding in France to date. The provision of this funding will ensure that qualifying heart failure patients within France will receive early access to this promising technology.

“We are excited to have implanted the first SOLVE CRT patient in France and are encouraged by the support of the Ministry of Social Affairs and Health for the use of this approach in our patients,” commented Professor Pascal Defaye, MD of Centre Hospitalier Universitaire de Grenoble. “We hope that the current study confirms the results of earlier clinical evaluations of this approach.”

“We are thrilled that the Ministry has chosen to provide such an honor to the WiSE CRT System following the assessment of the team at the Haute Autorite de Sante,” said Allan Will, Executive Chairman of EBR Systems. “We hope this award will enable many deserving patients in France to receive this life-changing therapy.”

The SOLVE CRT Study began in early 2018. It will enroll up to 350 randomized worldwide and is expected to complete enrollment in mid-2020. – NS Medical Devices