EBR Systems, a developer of wireless cardiac stimulation for heart failure, has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its Wireless Stimulation Endocardially (WiSE) CRT System for the treatment of heart failure.
Heart failure is a severe, progressive, debilitating disease condition where the heart fails to pump blood in required amounts for the body.
It is often caused due to the disruption of electrical signals within the heart, making its ventricles beat in an uncoordinated or unsynchronized pattern, resulting in enlarged left ventricle and weak heart.
Traditionally, Cardiac Resynchronization Therapy (CRT) is set to improve heart failure symptoms by electrically stimulating the heart, using wire leads to synchronise the left and the right ventricles, enabling two chambers beat together.
EBR Systems president and CEO John McCutcheon said: “This Breakthrough Device Designation underscores the need for novel solutions for heart failure patients, who have few options today. We are excited that the WiSE System has received Breakthrough Status, which will enhance the review process to bring this important technology to these patients.”
WiSE CRT system deploys advanced pacing technology
EBR has developed the WiSE CRT System to improve the blood pumping capability of heart through synchronizing the left and right ventricles, enabling effective distribution of blood to the lungs and body.
WiSE has been designed to deploy a unique wireless electrode as small as a grain of rice, implanted in the left ventricle wall during a minimally invasive procedure, to regulate the accurate pacing from within the heart.
The treatment technique is set provide greater choice of pacing locations for cardiologists, and enables patient-specific customisation of pacing site and improves conventional CRT response.
EBR said that the IDE-approved SOLVE CRT clinical trial, a prospective randomised, double blinded pivotal study is evaluating the safety and efficacy of the WiSE CRT System’s pacing technology.
The study is enrolling 350 heart failure patients across the US, Europe, and Australia who have failed to respond to, or unable to receive conventional CRT.
