Currently, the ClariTEE™ probe can only be used on the Zura™ system, manufactured by ImaCor. The ultrasound imaging market does not currently follow an “open platform” model whereby the probes of one manufacturer are compatible with the imaging system of another manufacturer.

No. The ClariTEE™ probe is a single patient use disposable that can be used for up to 72 hours in a single patient. It is not designed to be cleaned.

Before the ClariTEE™ probe, no ultrasound TEE probe was indicated for a specified dwell time of any duration by the FDA. We picked the time of 72 hours, believing that the critical period for stabilization would be 18-36 hours. As part of our clinical trials, we tested the durability and safety of the ClariTEE™ probe to 72 hours and received FDA clearance for 72 hours.

The ClariTEE™ probe is a monoplane (0o) probe and can be used to complete a full monoplane exam of the heart.

The ClariTEE™ probe is indicated only for trans-oral insertion.

No.

The Zura system will simultaneously support an unlimited number of ClariTEE™ probes.

Yes. Each disposable probe has a chip which identifies a specific probe with a specific patient after certain identifiers are input. When a probe is re-attached to the Zura™ system, it recognizes that probe and associates it with a specific patient. The Zura™ system automatically places the new images in that patient’s folder on the system’s hard drive.

The Zura system with ClariTEE probe are provided with Color Flow and B imaging modes

Currently, the tracing tools are manual.

We do not currently offer probes that can be used to assist in line placement or to obtain other trans-thoracic or trans-abdominal views.

Yes. The Zura™ system is DICOM compatible.

It depends on your baseline understanding and experience with ultrasound imaging. For example, the training requirement for a cardiac anesthesiologist who routinely performs TEE will be less than it will be for someone with little or no echo experience.

Yes. ImaCor will offer various professional education opportunities to physicians interested in learning how to properly use the Zura™ system and ClariTEE™ probe. Consult our website or your ImaCor sales representative for training dates and locations.

There are several difficulties associated with assessing cardiac function over a period of time with TTE in the ICU. First, the patients are often unable to comply with re-positioning and breath-altering techniques which facilitate imaging. Second, ICU patients may often have anatomical variations due to recent trauma or surgery. Third, conventional imaging windows may be unavailable due to the presence of chest incisions or tubes. Even in the event that a window is available and clinically useful images are obtained, subsequent exams of the same patient may or may not produce comparable images that can be compared to the baseline images for the purpose of evaluating heart function over time.

Trans-esophageal echo is a valuable tool for assessing cardiac function. While it is routinely used in the cardiac OR, its use in the peri-operative and ICU areas of the hospital as a monitoring tool is limited by the large size of the probe. Moreover, these machines and equipment are very expensive, and it is cost prohibitive to dedicate a TEE machine and probe to a single patient for 3 days.