FDA Clears Ventec's Five-In-One Portable Respiratory Device
By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Ventec Life Systems' VOCSN, a portable respiratory system that combines five separate medical devices — a ventilator, oxygen concentrator, cough assist system, suction, and nebulizer.
VOCSN is indicated for patients with chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, or lung cancer, neuromuscular disease, spinal cord injury, and pediatric complications, and is expected to be available in the U.S. beginning in 2017.
"Our team didn’t want to create just another ventilator, we spent the past five years focused on building a truly integrated solution," said Doug DeVries, founder and CEO at Ventec, in a press release.
Design input from more than 30 engineers, as well as from patients and healthcare providers, contributed to the development of what Ventec claims is the only portable life support device to combine five respiratory therapies.
VOCSN integrates a portable critical care ventilator, a 6 L/min portable oxygen concentrator that's three times more energy efficient than existing concentrators, a Touch Button Cough Assist feature that uses the same circuit for ventilation, a hospital-grade suction system for mucus management, and a high-performance nebulizer. More than 70 percent lighter and smaller than existing machines, the integrated system allows switching between therapies with the touch of a button and features the Ventec One-Circuit instead of multiple tubes connecting from different devices.
Ventec says its five-in-one device can be used across the full range of care settings, from home care to hospitals, and for all ages, from pediatric to elderly populations.
“Traditional devices are bulky and confusing to use and require caregivers to constantly switch the patient between multiple devices,” a Ventec spokesperson told COPD News Today. “VOCSN went through hundreds of user tests to create a unified system that was easy to use and operates much more like a smartphone than a medical device. The everyday mobility of VOCSN allows patients and caregivers to have all five therapies accessible at all times — whether a parent needs suction for their child during a car ride, or a respiratory therapist needs oxygen for a patient during a hospital elevator ride.”
Ventec plans to release VOCSN units on a limited basis in the U.S. starting in June 2017, followed by Asia later this year. Roll-outs in the Canadian and European markets are to follow in 2018.