EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval.
Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. 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 patient-specific location inside the left ventricle.
The FDA approved the Solve-CRT study back in September 2016. The randomized, double blinded pivotal trial will compare treatment with the Wise device to a sham procedure in which the device is implanted but not activated in patients who failed to respond to or are otherwise unable to receive conventional cardiac resynchronization therapy, according to ClinicalTrials.gov.
The primary safety outcome is freedom from procedure- and device-related complications at six months, including electrode dislodgement, migration or malfunction; vascular complications from the procedure; transmitter/battery pocket complications; and stroke/transient ischemic attack.
Solve-CRT has three primary endpoints, all at six months: mean change in left ventricular end systolic volume; the percentage of subjects with an improvement of greater than 15% in LVESV; and a composite improvement measure using the New York Heart Assn. scale, quality of life, heart failure events and death.
The first patients in the study were treated in Germany, Australia, the U.K. and the U.S., EBR System said.
“We believe Solve-CRT to be a landmark study that will build on previous positive results of this first-of-its-kind innovation for heart failure patients,” chairman & CEO Allan Will said in prepared remarks. “We are thrilled to have the participation and enthusiasm from so many world-class sites, who are motivated to expand the benefits of CRT therapy to patients who currently have no promising therapeutic alternatives.”
“Wireless pacing promises to address an important unmet need for patients with heart failure. Studies have demonstrated successful cardiac resynchronization therapy improves symptoms and reduces hospitalizations and mortality, but many patients do not respond to traditional CRT devices and have limited therapeutic options,” added global principal investigator Dr. Jagmeet Singh of Boston’s Mass. General Hospital. “I am excited to lead this important trial to hopefully confirm earlier promising results in a larger population and demonstrate WiSE CRT’s potential as a new option for patients who would otherwise face progressive deterioration of their condition and repeated hospitalizations.”
EBR won CE Mark approval in the European Union last October for the WiSE device, based on the 39-patient Select-LV trial in patients who either could not undergo traditional cardiac resynchronization therapy or failed to respond to it. The company raised $50 million last November.