Spiracur Announces First European Study Evaluating Outcomes for Treatment of Lower Extremity Diabetic, Venous and Mixed Etiology Wounds
(firmenpresse) - SUNNYVALE, CA -- (Marketwire) -- 11/15/11 -- ., developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, announced today that a prospective study to evaluate outcomes for the treatment of lower extremity diabetic, venous and mixed etiology leg wounds using the is underway at in Wales. The Department of Dermatology and Wound Healing is enrolling up to 45 patients for treatment at the outpatient wound clinics at Cardiff & Vale Universities Local Health Board and Aneurin Bevan Local Health Board. This is Spiracur's first European study since the company obtained CE Mark for the SNaP System in December of 2010.
The principal investigator for the prospective study is Professor Keith Harding, Director, Institute for Translation, Innovation, Methodologies and Engagement (TIME), Cardiff University School of Medicine. Through data analysis and outcomes, Professor Harding and his co-investigators will evaluate the efficacy of the SNaP system for treating difficult to heal lower extremity wounds and the impact on quality of life, reduction in pain and levels of exudate.
"The fact that results of the U.S. multi-center randomized controlled trial (RCT) show significant improvement in the patient's quality of life during wound healing is quite promising," said Professor Keith Harding. "We are eager to apply this device to patients who are candidates for NPWT devices in the U.K., as we believe the SNaP System may redefine how chronic wounds are treated worldwide."
The Department of Dermatology and Wound Healing at Cardiff University treats approximately 9,000 patients annually. Wound treatment, specifically lower extremity wounds, represent a significant cost burden in the United Kingdom, and it is estimated that this cost is likely to increase in the future as the population ages. Approximately five percent of all health care expenditure is devoted to wound care.
"The commencement of the first international study using the SNaP System is very important to Spiracur and it should add to the growing body of literature highlighting the importance of different wound care treatment choices," said , president and CEO of Spiracur Inc. "There is clearly a need for patients to have better wound care treatment options that address quality of life issues during their wound healing. We are very pleased with the final results of the U.S. RCT study, and we look forward to final outcomes from the Cardiff University study."
The prospective study will continue patient enrollment with final results expected in early 2013.
The School of Medicine at Cardiff is one of the largest in the UK, employing nearly 500 academic and 300 support staff. Over 1,000 undergraduate and 1,100 postgraduate students are currently enrolled on medical and science courses. The School is based at University Hospital of Wales in Cardiff and at other sites within Wales. Since its foundation in 1893, the School of Medicine has been committed to the pursuit of improved human health, through education, research and engagement with the wider world.
Spiracur Inc., headquartered in Sunnyvale, Calif., is a privately held medical device company focused on the development of innovative wound healing technologies. Spiracur was founded out of the Stanford Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The SNaP Wound Care System was cleared by the U.S. Food & Drug Administration (FDA) in August 2009 in a new therapy category defined as "non-powered" NPWT devices, and the company obtained CE Mark for the device in December 2010. For more information, please visit .
Spiracur, Spiracur logo, SNaP, SNaP & Design and Smart Negative Pressure are registered trademarks of Spiracur Inc.
VAC is a registered trademark of Kinetic Concepts, Inc.
Amy Cook
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Datum: 15.11.2011 - 08:01 Uhr
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