EBR Systems, Inc.
EBR Systems Inc. is a pioneering medical device company focused on revolutionizing cardiac rhythm management through innovative, leadless pacing systems. Their flagship WiSE CRT System is the world's first leadless left ventricular endocardial pacing device, designed to improve heart failure treatment with a size of a grain of rice and wireless ultrasound power. The company emphasizes values such as Patients First, Positivity, Leadership, and Expression, and has achieved significant milestones including FDA breakthrough device designation and successful clinical trials. EBR aims to bring ground-breaking therapies to market, with initial focus on the US, Australia, and Europe, and is supported by long-term investors and industry leaders.
Industries
Nr. of Employees
medium (51-250)
EBR Systems, Inc.
Sunnyvale, California, United States, North America
Products
Leadless intracardiac electrode
Ultra-compact implantable electrode designed for left ventricular endocardial pacing; intended for catheter-based implantation and designed to promote endothelial coverage to reduce thrombogenic risk.
Subcutaneous ultrasonic transmitter and power module
Implantable subcutaneous transmitter paired with a battery/power module that detects pacing pulses from a co-implant and transmits ultrasonic energy to an implanted electrode to enable wireless pacing.
Electrode catheter and delivery sheath
Catheter and delivery sheath systems engineered to position and deploy leadless electrodes within the left ventricle via transseptal or retrograde approaches.
External programmer and clinical programming tools
External programming system (hardware and software) for configuring and interrogating implanted pacing systems, including tools for peri-procedural configuration and follow-up diagnostics.
Leadless intracardiac electrode
Ultra-compact implantable electrode designed for left ventricular endocardial pacing; intended for catheter-based implantation and designed to promote endothelial coverage to reduce thrombogenic risk.
Subcutaneous ultrasonic transmitter and power module
Implantable subcutaneous transmitter paired with a battery/power module that detects pacing pulses from a co-implant and transmits ultrasonic energy to an implanted electrode to enable wireless pacing.
Electrode catheter and delivery sheath
Catheter and delivery sheath systems engineered to position and deploy leadless electrodes within the left ventricle via transseptal or retrograde approaches.
External programmer and clinical programming tools
External programming system (hardware and software) for configuring and interrogating implanted pacing systems, including tools for peri-procedural configuration and follow-up diagnostics.
Services
Clinical trial conduct and registry management
Design, execution and oversight of clinical studies and multicenter registries evaluating safety and efficacy of leadless left ventricular endocardial pacing systems.
Physician training and simulator programs
Simulator-based and on-site training programs to teach implantation techniques, device handling and peri-procedural management for implanting physicians and clinical teams.
Regulatory documentation and IFU distribution
Preparation and provision of Instructions for Use (IFU), patient information booklets and region-specific regulatory labeling and downloads to support clinical use and compliance.
Commercial site engagement and rollout support
Support for commercial readiness including engagement with high-volume clinical sites, reimbursement pathway preparation and initial implantation support.
Clinical safety guidance and device programming support
Provision of clinician-facing safety guidance for imaging and therapeutic interactions with ultrasound-sensitive implants, plus programmer support to configure or disable pacing modes and instructions for post-event device verification.
Clinical trial conduct and registry management
Design, execution and oversight of clinical studies and multicenter registries evaluating safety and efficacy of leadless left ventricular endocardial pacing systems.
Physician training and simulator programs
Simulator-based and on-site training programs to teach implantation techniques, device handling and peri-procedural management for implanting physicians and clinical teams.
Regulatory documentation and IFU distribution
Preparation and provision of Instructions for Use (IFU), patient information booklets and region-specific regulatory labeling and downloads to support clinical use and compliance.
Commercial site engagement and rollout support
Support for commercial readiness including engagement with high-volume clinical sites, reimbursement pathway preparation and initial implantation support.
Clinical safety guidance and device programming support
Provision of clinician-facing safety guidance for imaging and therapeutic interactions with ultrasound-sensitive implants, plus programmer support to configure or disable pacing modes and instructions for post-event device verification.
Expertise Areas
- Leadless intracardiac device engineering
- Ultrasound-based wireless power systems for implants
- Cardiac resynchronization therapy and electrophysiology
- Clinical trial management and registry operations
Key Technologies
- Leadless intracardiac electrode
- Ultrasound energy transfer for implanted devices
- Subcutaneous ultrasonic transmitter and power module
- Transseptal catheter delivery systems