FDA Clears VOCSN 5-in-1 Life Support Device

 

Ventec Life Systems Receives FDA 510(k) Clearance of VOCSN, the First Portable
Unified Respiratory System for Patients on a Ventilator

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VOCSN seamlessly integrates five devices – a critical care ventilator, oxygen
concentrator, cough assist, suction, and nebulizer – into one simple, mobile device.
Bothell, WA – April 12, 2017 – Ventec Life Systems, an innovator in integrated respiratory
care solutions, announced today it received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for VOCSN, the only portable life support device to combine five
respiratory therapies – Ventilation, Oxygen, Cough, Suction, and Nebulization (VOCSN,
pronounced VOX-SEN).
VOCSN works across the continuum of care, from the hospital to home, and for pediatric
patients weighing more than 5 kg to adults. VOCSN is designed to improve care for patients
with neuromuscular disease (e.g., Muscular Dystrophies, ALS), impaired lung function (e.g.,
COPD, Cystic Fibrosis, Lung Cancers, Emphysema), spinal cord injury, and pediatric
development complication (e.g., premature births, Chronic Lung Disease). Patients can get all
five therapies or just the mix of therapies needed.
VOCSN is more than 70% lighter and smaller than existing machines, features a nine-hour onboard
battery, and is controlled through an intuitive touchscreen interface and user-friendly
operating system. With VOCSN, caregivers can seamlessly switch between therapies with the
touch of a button and no longer need to change the patient circuit between therapies.
VOCSN enables caregivers to spend less time managing machines and more time caring for
patients.
Following his father’s diagnosis with ALS, Doug DeVries, Founder and Chief Executive Officer
at Ventec, dedicated his work to creating better solutions for ventilator patients, including the
portable LTV Series™ of ventilators. “I’ve seen firsthand how improved ventilator technology
can enhance the quality of life for patients and caregivers. Our team didn’t want to create just
another ventilator, we spent the past five years focused on building a truly integrated
solution.” New technology was developed to provide best-in-class treatment in a smaller, more
energy efficient system. VOCSN is engineered and manufactured in the United States with
eight pending patents.
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VOCSN is inspired by ideas from patients, caregivers, medical professionals, and a team of
more than 30 leading engineers. “Since the iron lung, respiratory equipment has limited the
mobility of ventilator patients. VOCSN was designed for everyday mobility so that patients can
focus on their relationships with loved ones and live their life,” said Richard Branson, Professor
of Surgery, University of Cincinnati and a member of the Ventec Clinical Board.
VOCSN Includes a Portable Critical Care Ventilator
VOCSN is a portable critical care ventilator that provides invasive, noninvasive, and
mouthpiece ventilation. Designed to work in hospital, institutional, transport, and home
environments, VOCSN delivers a comprehensive set of ventilation modes and settings to meet
patient needs. The advanced ventilation technology combines responsive leak and circuit
compensation as well as precision flow trigger controls to enable comfortable breathing and
accurate therapy.
VOCSN Includes a 6 L/min Portable Oxygen Concentrator
VOCSN is a portable oxygen concentrator that delivers the equivalent of 6 L/min of oxygen.
The VOCSN Oxygen-Direct™ system is up to three times more energy efficient than existing
concentrators. In addition to the on-board internal Oxygen Concentrator, external oxygen
sources can be connected to VOCSN for critical care patients. VOCSN also includes an
onboard FiO2 monitor to verify accurate oxygen delivery.
VOCSN Includes a Portable Touch Button Cough™ Assist
By unifying ventilation, cough, and suction into one system, it now takes seconds instead of
minutes to administer cough therapy with Touch Button Cough™. The Ventec One-Circuit™
features a high flow valve design, allowing patients to use the same circuit for ventilation and
cough. Using the Cough + Suction feature and Ventec Secretion Trap, suction therapy is
activated during the cough therapy to clear secretions. Once the set number of cough cycles is
complete, ventilation automatically resumes.
VOCSN Includes a Portable Hospital Grade Suction System
The VOCSN high flow suction provides quiet and effective airway clearance with consistent
and precise vacuum pressure. The suction system, together with the Ventec Secretion Trap,
simplifies mucus management by allowing patients to remain connected to the same circuit
during ventilation, cough, and suction therapies. The advanced sound muffler in VOCSN makes
suction therapy more than three times quieter than traditional suction machines.
VOCSN Includes a Portable High Performance Nebulizer
VOCSN automatically compensates for the airflow from the ventilator when the nebulizer drive
is active to ensure accurate ventilation. VOCSN records data about each treatment and
automatically turns off the nebulizer once the therapy timer is complete.
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VOCSN Allows Patients to Switch Therapies Without Changing Circuits
The Ventec One-Circuit™ allows switching between therapies with the touch of a button. The
innovative circuit design includes four pending patents that make Touch Button Cough™ and
the Oxygen Direct™ system possible. Rather than several cumbersome tubes connecting to
separate devices, the Ventec One-Circuit™ eliminates clutter to create one easy-to-manage
system for peace of mind.
VOCSN Ships to Patients and Caregivers in June 2017
The Ventec team will continue collaborating with respiratory thought leaders to introduce
VOCSN across the continuum of care. Over the next year, Ventec will work with select partners
on a controlled rollout to maintain a close connection between patients and caregivers. Limited
quantities of VOCSN will ship in the United States beginning in June 2017, Asia in 2017, and
Canada and Europe in 2018. VOCSN is customizable to each patient and its transparent
pricing model will allow therapies to be priced independently. Patients can get all five
therapies or just the mix of therapies needed. For technical specifications and ordering
information, visit VentecLife.com.
About VOCSN
VOCSN integrates five separate devices including a ventilator, oxygen concentrator, cough
assist, suction, and nebulizer into one unified respiratory system. Patent pending technology
includes the Ventec One-Circuit™ which offers continuous, uninterrupted ventilation designed
to reduce the risk of circuit misconnects. Lightweight for easy transport, VOCSN is controlled
with an intuitive touchscreen operating system enabling exclusive functionality to switch
between therapies with the touch of a button. VOCSN is simple, mobile, and care changing for
pediatric and adult patients and caregivers from the hospital to home.