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FDA批准iTraumaCare上市iTClamp出血控制系统

iTraumaCare2013年5月31日 18:10 点击:1385

美国食品药品监督管理局(FDA,U.S. Food and Drug Administration)   iTraumaCare Innovative Trauma Care

FDA批准iTraumaCare上市 iTClamp出血控制系统,该产品用于创伤性损伤患者,在几秒钟内阻止急性出血。该设备已经在加拿大出售,计划在30-45天内在美国发售。
[May 28, 2013 – SAN ANTONIO, TEXAS]  , an early-stage medical device firm focused on developing traumatic injury solutions for first responder and military medicine applications, has achieved its third regulatory milestone. The US Food and Drug Administration (FDA) granted the company 510(k) clearance to market its first product, the iTClampHemorrhage Control System, in the United States. The product, which was licensed for sale in Canada in late 2012 and received its CE Mark for sale in Europe in March 2013, will be available to medical professionals in the US within 30 to 45 days.  

The iTClamp™ is designed to control severe bleeding – a leading cause of death in traumatic injury – in seconds. The iTClamp™ seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired. 

510(k) clearance by the US FDA indicates that the iTClamp™ meets with the FDA’s regulatory standards for patient safety and efficacy. FDA clearance is required for the commercial sale and distribution of Class II medical devices in the US, like the iTClamp™.  

iTraumaCare’s CEO and founder, Dr. Dennis Filips, said, “With this regulatory milestone achieved, we look forward to putting the iTClamp in the hands of health care professionals in the United States and improving patient care.”

Incorporated in 2010 and based in Edmonton, Canada with its global commercialization ­­­­headquarters in San Antonio, Texas, iTraumaCare is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.  

(来源: iTraumaCare )


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