Vyaire Medical said today that it has won FDA 510(k) clearance for its Bellavista 1000e ventilator for the integration of high-flow oxygen therapy and advanced synchrony support.
The Chicago-based company’s Bellavista 1000e ventilator is designed to improve the caregiver’s experience, offering a touch screen with advanced graphics to simplify the process of escalating care or weaning a patient by reducing operator error and ventilator lengths of stays, according to a news release.
Vyaire’s Bellavista 1000e offers ventilation and lung protection centered around minimizing respiratory distress through advanced synchronization, reduced workload for clinicians and versatility with ventilation modes.
The Bellavista 1000e ventilator’s approval includes support for neonatal to adult patients, all in one single device with which clinicians are able to rapidly change therapies on a broad range of patients. Vyaire said more than 8,200 Bellavista 1000e ventilators are in use across 92 countries outside the U.S. already.
“Clinicians, respiratory therapists and bedside caregivers provided critical input in the design of this ventilator and helped us ensure we addressed their challenges in all patient care circumstances,” Vyaire chief marketing & innovation officer Lisa Rose, said in the release. “The Bellavista 1000e is a solution that provides the ultimate versatility in therapy and it can be adjusted quickly depending on patient need in time-sensitive situations. These differentiators are critical in a healthcare environment which expects innovative products to improve patient outcomes. Vyaire is dedicated to developing the kinds of systems and products that meet the needs of healthcare providers.”
“We began using Bellavista exclusively in 2017, when it was available in Europe,” added University Children’s Hospital of Zurich’s deputy chief physician Dr. Vincenzo Cannizzaro. “It allows us to ventilate invasive, non-invasive, nasal CPAP and perform high flow oxygen therapy with one device enabling targeted, efficient patient care in any situation.”