Healthcare Industry News: NPWT
News Release - March 8, 2011
Study Published in Wound Repair and Regeneration Highlights Significant Improvements in Chronic Wound Care Treatment OptionsInterim Analysis Supports Efficacy and Safety of Spiracur's Mechanically Powered SNaP Wound Care System and Non-Inferiority Compared to Traditional Electrically Powered Vacuum-Assisted (VAC) Closure System
SUNNYVALE, CA--(Healthcare Sales & Marketing Network) - Spiracur® Inc., the developer of an ultraportable and disposable negative pressure wound therapy (NPWT) device, today announced encouraging interim results from a clinical study highlighting the safety and efficacy of its SNaP® Wound Care System for the treatment of chronic lower extremity wounds. The study was published in the March-April 2011 issue of Wound Repair and Regeneration, the official peer-reviewed journal of the Wound Healing Society.
The 12-center randomized-controlled trial (RCT) was performed under the guidance of David G. Armstrong, DPM, M.D., Ph.D., William A. Marston, M.D., Alexander M. Reyzelman, DPM and Robert S. Kirsner, M.D., Ph.D. The purpose of the study was to compare the ultraportable mechanically powered SNaP (Smart Negative Pressure) Wound Care System to the traditional electrically powered Vacuum-Assisted Closure (VAC®) Therapy System in the treatment of chronic lower extremity wounds. The trial enrolled 65 patients with lower extremity wounds who were randomly assigned to treatment with either the SNaP or VAC Systems. The trial evaluated treatment for up to 16 weeks, or until there was complete closure of the ulcer.
According to Dr. Armstrong, professor of surgery at the University of Arizona and principal investigator of the study, "The results from this trial are important for those of us dedicated to healing wounds and preventing amputations, as the SNaP System offers an important tool for treating these chronic conditions. This novel technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options."
Planned interim analysis of the first 65 patients from 12 centers found no significant differences in the proportion of subjects healed between the two devices evaluated or in percent wound size reduction. Non-inferiority was demonstrated between the two therapies in percent wound size reduction to the *p < 0.05 significance level. The study also found no significant differences in wound related complications such as wound infections.
The study's secondary endpoints included time for dressing change and Quality of Life (QOL) measurements. Results for device application time showed that patients required 21 minutes to apply the VAC System and only nine minutes to place the SNaP System on the wound area. QOL surveys demonstrated no significant differences in reported pain, perceived effectiveness and patient satisfaction between the devices, however, the SNaP System interfered less with overall activity, sleep and social interaction than the VAC System. When asked if they were able to work and perform normal daily activities while being treated with the NPWT device, 92.4 percent agreed that they could work and perform daily activities using the SNaP System compared to 33.3 percent of patients using the VAC System. One hundred percent of the patients using the SNaP System said the noise of the device never bothered them compared to 33.3 percent of patients using the VAC System. When asked about sleep disruption, 100 percent of patients using the SNaP System said the device did not bother them while trying to go to sleep, yet 41.7 percent of patients using the VAC System felt that their sleep was disrupted by the device.
"We are extremely encouraged by the interim data reported in this month's Wound Repair and Regeneration," said Kenton Fong, M.D., chief medical officer, Spiracur Inc. "This study clearly demonstrates the important opportunity our ultraportable, mechanically powered SNaP Wound Care System offers to patients and clinicians for the treatment of chronic wounds. The interim data also highlights there is a need for smaller, more discreet devices that improve patient compliance, enhance quality of life and ultimately, improve treatment outcomes."
About Spiracur Inc.
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 the FDA has defined as "non-powered" NPWT devices, and the company obtained CE Mark approval for the device in December 2010. The SNaP Wound Care System is indicated for patients who would benefit from a suction device for wound healing and further indicated for removal of small amounts of exudate (fluid) from chronic, acute, traumatic, subacute and dehisced wounds, as well as ulcers (such as diabetic or pressure), and surgically closed incisions. Spiracur strives to develop products that truly focus on patient care. For more information, please visit http://www.spiracur.com.
SNaP, Spiracur and the Spiracur Design are registered trademarks of Spiracur Inc.
VAC is a registered trademark of Kinetic Concepts, Inc.
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