SOURCE: Spiracur

Spiracur

April 22, 2014 09:01 ET

Multi-Center RCT Data to Be Presented at SAWC Spring Conference Substantiates SNaP System for Treatment of Venous Leg Ulcers

RCT Shows VLU Treated With SNaP System Had Higher Likelihood of Complete Wound Closure

SUNNYVALE, CA--(Marketwired - Apr 22, 2014) - Spiracur announced today that promising data from a multicenter randomized controlled trial (RCT), comparing the treatment of venous leg ulcers (VLU) using the ultraportable mechanically-powered (MP) SNaP® Wound Care System to an electrically powered (EP) negative pressure wound therapy (NPWT) system, will be presented during the Symposium on Advanced Wound Care (SAWC) Spring Conference, April 23-27, in Orlando, Fla. Spiracur develops the only mechanically powered advanced wound care solution that delivers the proven efficacy of NPWT.

The 13-center RCT was performed under the guidance of William A. Marston, M.D., David G. Armstrong, DPM, M.D., Ph.D., Alexander M. Reyzelman, DPM, and Robert S. Kirsner, M.D., Ph.D.

"The NPWT Comparative Effectiveness Trial was designed to compare two different NPWT devices in the treatment of VLUs as adjuncts to compression therapy, which has been used and shown to be beneficial in combination with advanced therapies for wound closure," said Dr. Marston. "Patients were recruited to participate in this prospective RCT and each subject was randomly assigned to treatment with either the MP SNaP System or the EP Vacuum-Assisted Closure (V.A.C.®) System from K.C.I.

"There has been a general lack of information on the use of NPWT for the treatment of VLUs," continued Dr. Marston. "We will present the results including wound reduction and closure in all patients and a comparison of results using different negative pressure devices. Hopefully this information will provide additional support for the use of negative pressure for recalcitrant VLUs not responding to compression protocols alone."

Forty patients (19 MP NPWT and 21 EP NPWT) completed the study with either healing or 16 weeks of therapy. Overall, 52.5 percent of VLUs healed at 16 weeks and the average wound achieved 50 percent closure at 5.9 weeks of treatment. At 30 days, 50 percent wound closure was achieved in 52.6 percent of patients treated with the SNaP System and 23.8 percent of patients treated with the V.A.C. System. At 90 days, complete wound closure was achieved in 57.9 percent of patients treated with the SNaP System and 38.15 percent of patients treated with the V.A.C. System. Data shows that V.A.C.-treated patients were twice as likely to not heal compared to SNaP-treated patients.

"The RCT data shows extremely promising results for the SNaP System when used to treat venous leg ulcers in comparison to treatment with the V.A.C. System," said Kenton Fong, M.D., chief scientific officer for Spiracur. "The results corroborate the feasibility of the SNaP System as a clear choice for VLU treatment supported by data revealing that wounds treated with the SNaP System demonstrated greater improvement and a higher likelihood of complete wound closure than those treated with the V.A.C. System."

This recent clinical data adds to a growing list of clinical studies that have been published supporting the SNaP System as an effective alternative to EP NPWT, including a 2012 comparative RCT that showed the powerful, small device makes a positive difference in patients' quality of life. The SNaP device is reimbursed by Medicare in wound care centers.

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 University Biodesign Innovation Program in 2007. Its first product, the SNaP Wound Care System for the treatment of chronic and acute wounds, is the result of patient and clinician feedback that current negative pressure wound therapies were too cumbersome. The company's ciSNaP® Closed Incision System with proprietary controlled tension relief is designed to improve healing of high-risk surgical incisions. Both devices have received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and have received CE Mark approval. Spiracur's proprietary mechanically powered technology does not require batteries or electricity to operate. For more information, please visit http://spiracur.com.

Spiracur, Spiracur logo, SNaP, SNaP & Design, and ciSNaP are registered trademarks of Spiracur Inc.

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