EBR Systems has raised US$50 million to conduct the global SOLVE-CRT (stimulation of the left ventricle endocardially) study. SOLVE-CRT is a pivotal clinical trial intended to establish safety and efficacy in support of US Food and Drug Administration (FDA) approval WiSE (wireless stimulation endocardially), a product of EBR Systems.
The company’s WiSE technology paces the heart via a wireless electrode implanted directly in the left ventricle with an initial indication sought for heart failure patients who have failed to respond to or are unable to receive conventional cardiac resynchronisation therapy.
The company has received European CE Mark approval for its second-generation wireless transmitter and conducted initial cases at four European clinical centers, and the money raised will go towards the SOLVE-CRT trial in support of the FDA’s safety and efficacy review of the CRT System. This major advance is half the size of the first-generation transmitter, extends battery life and enables a simpler and less-invasive implantation procedure. “The WiSE CRT system has enabled me to successfully treat many patients who had previously failed treatment with conventional CRT devices,” says Tim Betts of Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital (Oxford, UK). “Without WiSE, these heart failure patients would be relegated to progressive deterioration of their condition and repeated hospitalisations. The second-generation system has allowed me to transform a two-day or two-admission procedure into a single procedure treatment, minimising hospital stay and allowing the patient to experience the benefits of CRT immediately.”
Cardiac resynchronisation therapy for heart failure
Studies have demonstrated that successful CRT therapy reduces heart failure symptoms, hospitalisations and mortality by synchronising the left and right ventricles. More than one-third of annual pacemaker sales are for this indication. However, approximately 30% of patients receiving conventional CRT do not respond to the therapy. A major cause of this shortcoming is believed to be the inconsistency of results achieved using wire leads to pace the left ventricle from within the coronary sinus vein on the epicardial surface of the heart. Although it is generally accepted that stimulation of the left ventricle is preferable from inside the heart, wire leads or large implants placed inside the left ventricle can cause clots, heart attacks or strokes. Consequently, commercially-available CRT systems do not place leads there, using the coronary sinus instead. Additionally, wire leads can break or otherwise fail, leading to complications in roughly 12% of cases. The financial impact of these issues is profound. As much as US$1 billion of US$3.5 billion spent annually on CRT devices provides no patient benefit.
WiSE Technology is the first wireless endocardial pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is recognized as a potentially superior, more anatomically correct pacing location. The new technology addresses those problems by enabling cardiac pacing with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle–and the attendant problems–are potentially eliminated.
