Vapotherm(R) Precision Flow(TM) Receives FDA 510(k) Clearance
STEVENSVILLE, Md., Aug. 7 /PRNewswire-USNewswire/ -- Vapotherm, the
global leader in High Flow Oxygen Therapy products, has received 510(k)
clearance from the Food and Drug Administration (FDA) for Precision
Flow(TM), the first high flow humidification system to integrate gas
blending, flow control and humidification technology into one device for
the optimal conditioning of nasal cannula inspired gases.
Other Vapotherm products are currently used in neonatal, pediatric and
adult applications in hundreds of hospital locations throughout the US and
in over twenty countries. "The Vapotherm brand has become synonymous with
the category of high flow oxygen therapy. Precision Flow(TM) illustrates
our continued commitment to raising the technology standard and delivering
to the respiratory community the state of the art in noninvasive
respiratory assistance," said Robert Storey, President and CEO of
Vapotherm.
Precision Flow(TM) was developed with extensive input from clinical
professionals in neonatology, pediatrics and adult respiratory care. The
result is a device that combines performance, safety and ease of use for
optimal patient outcomes. "Vapotherm has been utilized with great success
in our neonatal unit. The new device offers our staff the same high flow
therapy benefits, with improved ease of use and performance features," said
Dr. Eleri Adams of the John Radcliffe Hospital at Oxford, England, a major
teaching hospital of NHS who has recently begun using Precision Flow(TM).
With the FDA clearance, the Company has initiated full-scale
production. Precision Flow(TM) is exclusively distributed in the US by a
network of specialty medical sales and marketing organizations. "The
Vapotherm product line has been a top performer for us," said Don Reiter,
President of Special Respiratory Care, Inc., a leading distributor of
respiratory products. "Based on feedback and early orders from our
customers, we expect Precision Flow(TM) to dominate the high flow market in
our region."
Vapotherm, Inc. is a privately held manufacturer of respiratory care
devices for hospitals and home care use based in Stevensville, Maryland.
The Company is dedicated to the development of innovative, noninvasive
technologies for respiratory therapy, especially for the treatment of
chronic lung and acute breathing disorders. For more information, visit
www.vtherm.com.
CONTACT:
Amy Elias
Profiles, Inc.
410-243-3790
amy@profilespr.com
SOURCE Vapotherm, Inc.
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