EBR Systems said Monday it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device.
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, which it uses to synchronize the left and right ventricles.
“A growing body of evidence strongly suggests EBR’s WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants. We look forward to working with leaders in the European clinical community to further characterize the benefits of wireless endocardial pacing,” CEO Allan Will said in prepared remarks.
The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient0specific location inside the left ventricle, the Sunnyvale, Calif.-based company said.
The approval came based on a feasibility study of the “wireless” pacemaker, presented in May, which confirmed the device’s safety and pointed the way toward further research.
The 39-patient Select-LV trial consisted of patients who either could not undergo traditional cardiac resynchronization therapy or failed to respond to it, Dr. Vivek Reddy of New York’s Mt. Sinai School of Medicine 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.