A feasibility study of the “wireless” pacemaker made by EBR Systems confirmed the device’s safety and pointed the way toward further research, according to Dr. Vivek Reddy of New York’s Mt. Sinai School of Medicine.
The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a "pellet" implanted on the inside of the heart, in the right ventricle, Reddy said today at the annual Heart Rhythm Society meeting in Boston. The 39-patient Select-LV trial consisted of patients who either could not undergo traditional cardiac resynchronization therapy or failed to respond to it, Reddy said.
"In 90% of patients it was possible to actually perform this approach," Reddy said. "In those patients in whom it was successful there were significant improvements in clinical outcome. Again, this is non-randomized so you can take it with a grain of salt.
"Ultimately, I think what this stud showed is that left ventricular pacing is possible, it appears to show significant benefits and we need to understand, if we did this in a large number of patients, how safe this can be," he said.
The study also raises the possibility that the EBR Systems device could be used beyond the patient population addresses in Select-LV, Reddy added.
"There is data that suggest that endocardial pacing may be more effect that epicardial or CS pacing, the standard approach, in terms of clinical outcome in the patients," he said. "That data is not conclusive, but it’s very interesting and I think an area of future research," he said.
Last month Sunnyvale, Calif.-based EBR raised a $20 million funding round joined by a former Medtronic (NYSE:MDT) executive and an unnamed "cardiovascular corporate strategic investor."
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