Technology | Ultrasound Transesophageal echo (TEE) | July 10, 2018

FDA Clears Visura Technologies' TEE Camera Assist Device System

Device addresses the challenge of blind TEE probe intubation

FDA Clears Visura Technologies' TEE Camera Assist Device System

July 10, 2018 — Evanston, Ill.-based startup Visura Technologies has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its transesophageal echocardiography (TEE) Camera Assist Device (TEECAD) System. TEECAD’s single-use disposable camera easily attaches to a TEE ultrasound probe, allowing physicians to view the upper airway and esophagus during probe placement for safe intubation.

TEE is a common cardiovascular procedure, performed more than 500,000 times annually in the U.S. During the procedure, an ultrasound probe is placed in the patient’s esophagus to capture high-resolution ultrasound images of the heart valves and atria. Physicians currently place TEE 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 esophageal or pharyngeal perforation.

Visura Founder David Marmor, M.D., a noninvasive cardiologist and experienced TEE operator, commented, “TEE-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 TEE 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 TEE probe intubation.”

The TEECAD System consists of a single-use disposable camera Carrier that removably attaches to the TEE probe, and a separate Viewing System display that 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. The company plans to develop additional Carrier models compatible with other TEE probes available in the market.

For more information: www.visuratechnologies.com

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