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WE ARE | Women's Health

MiniArc Sling Three-Year Preliminary Data

AMS an endo international company

Three-year preliminary results of the randomized 522 postmarket surveillance study of the MiniArc Single-Incision Sling System compared to the Monarc Subfascial Hammock were presented at IUGA in Nice, France in June, 2015.1


At 3 years, results continue to show MiniArc sling is non-inferior, with additional benefits.

  • At 3-year follow-up, MiniArc sling proved to be non-inferior to Monarc sling regarding objective and subjective cure:

- Objective outcomes:
MiniArc: 90% (n=61)
Monarc: 87% (n=62)

- Subjective outcomes:
MiniArc: 86% (n=57)
Monarc: 86% (n=62)

  • Adverse events were comparable between the two products

  • MiniArc sling had statistically lower postoperative pain scores, shorter operative time, and less intraoperative blood loss than Monarc sling

Objective cure defined as a negative CST. Subjective cure defined as not or mildly bothered by SUI based on the PGI-I.

 

WE ARE committed to Women’s Health

  • This trial represents our commitment to physicians, to patients, and to supporting women’s health therapies
  • The 3-year report to the FDA is expected in early 2016

For additional information, please click here.

  1. Roovers J, Schellart RP, Rengerink KO, et al. A randomized comparison of single incision midurethral sling (MiniArc) and standard midurethral sling (Monarc) in women with stress urinary incontinence: results at 36 months follow-up. Abstract presented at: 40th Annual Meeting of the International Urogynecological Association; June 2015; Nice, France.

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AMS an endo international company

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