On November 24, 2021, EBR Systems went public in the Australian stock exchange. According to the press release, the IPO raised AU$110M (around $78.5M). EBR pland to use these funds to complete its pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch.
Medtronic Micra™, Boston Scientific Empower™, and St Jude (Abbott) Nanostim™. Scale is approximate
I just came back from HRS 2019 in SF, and the implantable devices buzz this year was around leadless pacemakers and defibrillators. Most importantly, they are no longer considered a technical curiosity, but rather are entering the mainstream as a serious alternative to leaded devices.
In the bradycardia field, Medtronic showed how their MICRA™- the only commercially-available leadless pacemaker at this time – is able to pace the ventricle in sequence with the atrium through the use of a 3D accelerometer that senses the atrial contraction.
Researchers using the Boston Scientific EMPOWER™ Modular Pacing System showed how it can communicate with Boston’s EMBLEM™ S-ICD System to provide brady and ATP pacing.
On its side, Abbott is said to be working to relaunch the plagued NANOSTIM™ leadless pacemaker after early battery depletion issues caused St. Jude to issue an advisory in October 2016, followed by Abbott maintaining the worldwide halt on implantations because of problems with the device’s docking button.
More mention is also being made of EBR’s LV pacemakers as an alternative to GCV leads to deliver CRT.
EBR’s WISE wireless LV pacemaker is powered from an ultrasonic generator implanted outside the heart.
Medtronic announced at TEDMED 2010 that it is working on leadless pacemakers. Dr. Stephen Osterle, senior vice president of medicine and technology and member of Medtronic’s Executive Management Team, unveiled the device. Osterle said that physicians will be able to control the device with a smart phone.
EBR Systems, Inc., founded in 2003 and headquartered in Sunnyvale, CA, is developing the WiCS® Wireless Cardiac Stimulation technology to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. The startup was spun out of research by founder Debra Echt, a former professor of medicine and a cardiologist at Vanderbilt University. Continue reading
Nanostim is an early-stage AIMD company in Milpitas, CA that is developing a pacemaker that can be implanted inside the heart through a catheter. The tiny device is attached directly to the heart, eliminating the need for leads.
In May 2011 Nanostim announced that St. Jude Medical had made a substantial investment in the company.
The company is operating in stealth mode, but some details about the leadless pacemaker have emerged from Nanostim’s patents and patent applications. An interesting detail is about the possible use of a betavoltaic power source: Continue reading
Morgan Technical Ceramics (MTC) announced that its Bedford, Ohio site manufactures the piezoelectric ceramic materials used in EBR Systems, Inc.’s innovative new WiCS® Wireless Cardiac Stimulation System. The PZT (lead zirconate titanate) material made by MTC is critical to the efficiency of the WiCS system, which is powered by a battery with a 10-year lifespan.
The WiCS technology, which recently began clinical trials, is the first truly wireless pacing device. It was developed to eliminate cardiac pacing leads, historically a major source of complications and reliability issues. Continue reading