Vapotherm(R) Precision Flow(TM) Receives FDA 510(k) Clearance

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 08 Aug 2008 - 1:00 PDT

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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 http://www.vtherm.com.

Vapotherm, Inc.
http://www.vtherm.com

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