Authors: Maren Healey, Nova Szoka MD, FACS, FASMBS
Inovytec Medical Solutions Ltd. received FDA approval for the Ventway Sparrow ventilator on January 29, 2021.
The Ventway Sparrow is a compact, portable ventilator weighing 2.2 pounds that can be used in the hospital, pre-hospital, and field environments for invasive and non-invasive ventilation. Specifically, the ventilator is intended for emergency use and for use during transportation. The Magnetic Resonance (MR) compatible models are suitable for use in hospital settings and may be used in an MR environment up to 3 Tesla.
The Ventway Sparrow consists of a ventilator unit with an LCD screen and a single use patient circuit. It has a built-in turbine that cools the device and delivers oxygen to the patient. The internal battery can run without an external power source for up to 4 hours. An optional quick start mode enables the user to start ventilation within five seconds.
The FDA determined that the ventilator is substantially equivalent to predicate devices. It has the same intended use and similar technological characteristics and principles of operation as the predicate LTV® 1200 Ventilator. Overall performance, design and features, and non-clinical testing show the Ventway Sparrow to be equivalent to the LTV® 1200 Ventilator.
- Adult and pediatric patients weighing ≥ 5 kg
- Need for SIMV VC PS, SIMV PC PS or CPAP support
- Need for invasive (via an endotracheal tube and tracheostomy) or noninvasive (full non-vented ventilation face mask) ventilation presets
- Use in hospital, pre-hospital, and field environments
- Use in a Magnetic Resonance (MR) environment up to 3 Tesla (Models VWSP100MR and VWSP900MR)