Introducing the The EpiAccess™ System

The real-time guidance and confirmation capability of the EpiAccess™ system are based on both disposable and hardware components. The disposable is an access needle that is used to provide single-use access to the pericardial cavity; the capital component contains the host computer and relevant algorithms.

FDA 510(k) clearance & CE Mark approval have been granted.

The EpiAccess™ Needle

The system includes a proprietary, tuohy-style needle with a fiber optic pressure sensor mounted permanently at the distal tip. The real-time pressure signal in combination with standard of care fluoroscopy is designed to provide the physician position guidance and needle tip position confirmation.

EpiAccess™ “SMART” Needle pictured during epicardial access.

Product being used as part of the EASe Clinical trial conducted in Europe.

Real-Time Feedback

Our instrumentation captures the pressure signal from the sensor and displays the signals on a monitor. The graphical user interface is easy to read, allowing physicians to understand the real-time pressure waveform intuitively.

The data provides guidance to the physician on the position of the needle so they can know when the needle has reached the desired location. The needle tip pressure wave form is designed to confirm access to the pericardial space.

EpiAccess™ screen capture showing typical pericardial signal.

The Control Unit

The control unit is designed to be easy to use, flexible and durable. Data capture equipment and a touch screen monitor are housed in a mobile cart that allows the user to position the system as desired.

Its design features allow quick and convenient transition from a “Secured” mode for storage to “Procedure Ready” mode. When in “Secured” mode, the control unit is more protected.

The control unit can be used as a stand alone monitor or integrated into most existing monitors; see below.

Stand Alone

The EpiAccess™ unit can be used as a stand alone device, as shown above. The monitor can be conveniently rolled into place and raised or lowered to the clinicians preferred position, typically adjacent to the fluoroscopy monitor.

Integrated System

The EpiAccess™ system can also connect to other monitors, such as a monitor within a monitor bank. Many clinicians prefer to position the EpiAccess™ system display adjacent to the fluoroscopy monitor, as shown above.

Product being used as part of the EASe Clinical trial conducted in Europe.