Devices

FDA OKs Study for Wireless CRT Pacing Leads

FDA has granted EBR Systems an Investigational Device Exemption for its WiSE (Wireless Stimulation Endocardially) technology for cardiac resynchronization therapy (CRT). The company says it is now planning a major U.S. study to establish safety and effectiveness data to support FDA approval.

The company says about 30% of patients receiving conventional CRT do not respond to therapy, with a major cause being “inconsistency of results achieved using wire leads to transmit pacing pulses to the left ventricle’s epicardial (exterior) surface. Although it is generally accepted that internal stimulation of the left ventricle is preferable, wire leads or large implants placed inside the left ventricle can cause clots, heart attacks or stroke. Consequently, this pacing location is not currently used by commercially-available CRT systems in the United States. Additionally, wire leads can break or otherwise fail, leading to complications in roughly 12% of cases.”

The WiSE Technology is designed to address these problems by enabling cardiac pacing with a novel, cardiac implant that is roughly the size of a large grain of rice, EBR says. “The need for a pacing wire on the outside of the heart’s left ventricle — and the attendant problems — are eliminated,” it says.

The study will evaluate 350 patients who have either failed conventional CRT or they were previously untreatable with conventional CRT systems. It will be a prospective, randomized controlled trial using generally-accepted measures of safety and efficacy as primary endpoints at six months, the company says.

In an earlier study involving 35 patients, 33 patients who reached the six-month effectiveness endpoint saw an 85% improvement in their clinical composite score which is a measure of symptom improvement, EBR says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome