Visura Technologies has received 510(k) clearance from the US FDA for its transoesophageal echocardiography (TOE) Camera Assist Device (TEECAD) system. A press release reports that TEECAD’s single-use disposable camera easily attaches to a TOE (or TEE in the USA) ultrasound probe—allowing physicians to view the upper airway and oesophagus during probe placement for safe intubation.
Physicians currently place TOE probes blindly, guided by physician feel and patient cooperation, potentially resulting in failed intubations that can lead to cancelled therapeutic procedures and major complications such as oesophageal or pharyngeal perforation.
Visura Founder David Marmor, a non-invasive cardiologist and experienced TOE operator, comments: “TOE-related complications and failed intubations can be dangerous for patients and have costly ramifications for hospitals. The recent proliferation of catheter-based structural heart interventions reliant on TOE imaging has led to growth in procedural volume and an increase in the age and risk profile of patients, increasing the need for visual guidance for safe TOE probe intubation. We look forward to clinically introducing our device.”
The TEECAD system consists of a single-use disposable camera Carrier that attaches (but can be removed) to the TOE probe and to a separate Viewing System display (which allows the physician to view real-time images from the camera to visually assist with safe probe intubation). The clearance of Visura’s first TEECAD camera Carrier is for use with the Philips X7-2t probe. Visura Technologies plans to develop additional Carrier models compatible with other TEE probes available in the market.
