EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]
EBR Systems said today that it raised a $30 million funding round and tapped ex-Ceterix Orthopaedics CEO John McCutcheon to be its new chief executive. The Sunnyvale, Calif.-based company is developing the Wise wireless pacemaker, designed to use a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle to […]
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 […]
Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]
EBR Systems said today it won an investigational device exemption from the FDA for a clinical trial of its WiSE wireless cardiac resynchronization therapy device. The Sunnyvale, Calif.-based company claimed the device as the world’s only wireless, endocardial pacing system for stimulating the left ventricle. “WiSE is unique, significant technology that’s cleared for use in Europe and has proven […]
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 […]
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 launch of a pivotal clinical trial next year for a “hybrid” procedure to treat atrial fibrillation patients will be an “inflection point” for cardiac surgical device maker AtriCure Inc.’s (NSDQ:ATRC) U.S. business, the company’s CEO said.
The pivotal clinical trial, which could lead to regulatory approval of the hybrid procedure to treat atrial fibrillation and is called DEEP AF, will involve expanding studies from six research centers to 35, CEO David Drachman said.