CE Clearance For ETView Medical’s VivaSight™-DL Innovative Airway Devices

In short

Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. The Company expects to immediately begin distribution of the VivaSight™-DL line of innovative airway devices in countries requiring CE registration of medical devices and already has a developing distributor network including new appointee Win-Med, signed up last week to cover Northern Italy.

Background

It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually, accounting for over $250m in single-use medical disposables.

ETView has pioneered development of the VivaSight™ platform (previously known as TVT™), combining an airway ventilation tube with integrated, continuous high-resolution airway imaging for patient airway control and lung isolation capability. In so doing it claims to have eliminating the need for fiberoptic bronchoscope imaging during these procedures.

VivaSight™-DL is a proprietary, single-use, disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.

Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or oesophageal surgeries.

During lung isolation, temporary visualisation of the patient airway is achieved with a fiberoptic bronchoscope while the patient is ventilated and the target lung isolated.

Intra-operative surgical manoeuvres often require repeated imaging and partial blocking of the airway to maintain lung isolation, which is inherently possible with the VivaSight system.

Company comments

“We are excited to have reached this milestone,” stated Bill Edelman, CEO. He continued, “VivaSight™-DL will be immediately available to the European thoracic surgical community following MDC(notified body) concurrence with our CE registration application. We anticipate significant clinical interest for VivaSight™-DL when it is cleared for commercial distribution.”

Regulatory status

On June 12, 2012, ETView announced US FDA Clearance of a 510(k) Pre-Marketing Notification Application for the Viva™ EB Line of Innovative Endobronchial Blockers.

On May 23, 2012, ETView announced US FDA clearance of a 510(k) Pre-Marketing Notification Application for the VivaSight™-DL line of innovative airway devices.

Source: ETView Medical, Ltd., Business Wire