Healthcare Industry News: NPWT
News Release - September 24, 2010
New Randomized Controlled Trial Supports Efficacy and Safety of Spiracur SNaP Wound Care SystemInterim Analysis Shows Non-Inferiority of SNaP Wound Care System Compared to Kinetic Concepts, Inc. Wound V.A.C. Therapy System
SUNNYVALE, CA--(Healthcare Sales & Marketing Network) - Spiracur, Inc. today announced important 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 data was presented this week at the Fall 2010 Symposium on Advanced Wound Care (SAWC) in Anaheim, Calif.
The 12-center, 65-patient randomized controlled trial (RCT) compared negative pressure wound therapy (NPWT) between the KCI Wound V.A.C. Therapy System and the SNaP Wound Care System for the treatment of chronic lower extremity wounds. The Poster was presented by 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 subjects were randomly assigned to treatment with either the SNaP System or the V.A.C. System, and the trial evaluated treatment for up to 16 weeks, or until there was complete closure of the ulcer.
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.
According to David G. Armstrong, DPM, M.D., Ph.D., professor of surgery at the University of Arizona and principal investigator on this study, "We have been using the technology for over a year now and our patients have responded well to this new portable therapy. For those of us dedicated to healing wounds and preventing amputations, this device provides an important tool for treating these chronic conditions. This novel technology may prove to hold substantial potential for patients requiring smaller NPWT treatment options."
"We are thrilled to have such positive clinical data presented at SAWC, as they clearly demonstrate the unique opportunity the SNaP Wound Care System offers to patients and clinicians for the treatment of chronic wounds," said Gary Restani, president and chief executive officer, Spiracur, Inc. "The response to our proprietary system has been extremely positive by both patients and clinicians, and we are confident that this new data will help increase awareness for and broaden adoption of the SNaP Wound Care System."
About the SNaP Wound Care System
The SNaP Wound Care System is an ultraportable negative pressure wound therapy (NPWT) device that was approved 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. The SNaP System provides the same level of negative pressure as competitive technologies; however, it requires no electric or battery power. In addition, the SNaP System, unlike powered NPWT, is silent, small and lightweight (weighing less than 3 oz.), which enables patients to wear the device under clothing and resume daily activity without exposing their wound care treatment to the world.
The FDA determined that the SNaP System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. The SNaP System is used for the removal of small amounts of exudate from chronic, traumatic, dehisced, acute, subacute and ulcer (diabetic or pressure) wounds. Additional information can be found by visiting http://www.spiracur.com/snapproduct.html.
About Spiracur, Inc.
Spiracur, Inc. 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, grew out of the notion that current negative pressure wound therapies were too cumbersome for patients and clinicians. Spiracur strives to develop products that are truly patient-centric. For more information, please visit http://www.spiracur.com.
SNaP, Spiracur and the Spiracur Design are registered trademarks of Spiracur Inc.
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