One Slim Needle One Incision. One Simple Solution for Stress Urinary Incontinence. The Difference is in the Data

Transcription

1 CONTINENCE SOLUTIONS One Slim Needle One Incision ordering information Description US International Order Number Order Number One Simple Solution for Stress Urinary Incontinence MiniArc Single-Incision Sling MiniArc Box of NA Single-inci sion sling sy stem Summary of Warnings, Precautions and Contraindications for the MiniArc As with any surgical procedure, inherent risks are present. Although rare, some of the most severe risks with sling procedures include infection, erosion, and vessel or urethra perforation. Some of the most common risks include urinary tract infections, urge symptoms and urinary retention. Sling procedures should not be performed on pregnant patients. For a complete list of indications, contraindications, warnings and precautions, refer to the product Instructions for Use or contact your AMS representative. This document is written for professional medical audiences. Contact AMS for lay publications. AMS periodically updates product literature. If you have questions regarding the currency of this information please contact AMS. The Difference is in the Data Author/Congress Study Details Pickens et al at AUA month prospective (n=120) Kennelly et al ICS month prospective (n=82) Urwin BAUS weeks prospective (n=28) Pickens ICS month prospective (n=60) Moore et al AAGL weeks retrospective (n= 60) Success Rate * Data on file at AMS. Cure defined as no pad usage Negative CST 86.0% Dry defined as negative CST or positive response to Q3 on UDI % AMS Women s Health Solutions MiniArc Single Incision Sling Monarc Subfascial Hammock SPARC Sling BioArc TO Subfascial Hammock Elevate Posterior Defined as no pad usage or complaints of any leaking 93.2% Objective & subjective (dry defined as negative CST or patient response) American Medical s, Inc. World Headquarters Bren Road West Minnetonka, MN USA U.S. Toll Free: Phone: American Medical s, Inc. All rights reserved. Printed in USA. Elevate Anterior Apogee Vaginal Vault Perigee Transobturator Anterior Prolapse Repair American Medical s Europe B.V. Straatweg 66H 3621 BR Breukelen THE NETHERLANDS Phone: F (03/10) The Simple Solution for Female Stress Urinary Incontinence Robert D. Moore, D.O., Atlanta Urogynecology Associates For physicians who have not felt comfortable with TVT or TOT, this procedure will open the door for them to be able to treat their patients who have SUI. MiniArc is the simplest and easiest sling to place on the market to date. It is safe, with early results reflecting equivalent cure rates to TVT and TOT slings. The MiniArc requires no groin incision, just one small vaginal incision. The self-fixating tips provide excellent fixation with the same pull-out strength offered by Monarc.

2 With more than 65,000 patients implanted, MiniArc is a proven procedure for the treatment of female stress urinary incontinence. Inspired by the market-leading Monarc Subfascial Hammock, the MiniArc follows the familiar transobturator trajectory for placement. Patient and Physician Feature Benefits: One slim 2.3 mm needle Utilizes AMS proven Type I polypropylene mesh with midline centering mark Single, 1.5 cm vaginal incision Patient: Minimizes tissue injury* Reduces potential for blood loss* Proven mesh facilitates healing and promotes tissue integration* Midline mark promotes accurate placement under the urethra to achieve continence Minimally invasive* Reduces number of incisions from 3 to 1 Potential for less post-operative pain* Can be used with local anesthesia* Physician: Designed to minimize dissection and lessen tissue disruption* Bench testing shows less push-in force required than TVT SECUR * Mesh has proven clinical efficacy and implantation in over 650,000 patients* Midline mark helps ensure proper placement under urethra Designed to minimize dissection* May reduce risk of bladder, bowel and major vessel perforation*

3 Pull-Out Force (lbs.) Typical Pelvic Floor Event (1.3 lbs) MiniArc (5.5 lbs.) Small, self-fixating tips are anchored in the obturator internus Simple mesh-to-needle connection with optional redocking feature Small, integrated self-fixating tips Quick, standardized placement technique Simplifies procedure Designed to promote proper tensioning to achieve continence Provides significant holding force without pain* Reduces potential for mesh movement after placement Early clinical evaluations indicate a shortened procedure time, potentially reducing the amount of anesthesia required* Smooth and easy engagement and disengagement of mesh to needle* Offers opportunity to realign needle to mesh for further intra-operative tightening during placement* Physicians report it is easy to use* Significant holding force helps prevent migration during initial tissue fixation and ingrowth* Bench testing shows that 5.5 lbs. of pull-out force is required to remove mesh compared to a typical pelvic floor event at approximately 1.3 lbs. of force* Minimizes concern over mesh movement during intra-operative needle disengagement Follows familiar Monarc transobturator trajectory, promoting easy placement Early clinical evaluations indicate that the procedure is faster to perform than traditional retropubic or transobturator approaches*

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5 CONTINENCE SOLUTIONS One Slim Needle One Incision ordering information Description US International Order Number Order Number One Simple Solution for Stress Urinary Incontinence MiniArc Single-Incision Sling MiniArc Box of NA Single-inci sion sling sy stem Summary of Warnings, Precautions and Contraindications for the MiniArc As with any surgical procedure, inherent risks are present. Although rare, some of the most severe risks with sling procedures include infection, erosion, and vessel or urethra perforation. Some of the most common risks include urinary tract infections, urge symptoms and urinary retention. Sling procedures should not be performed on pregnant patients. For a complete list of indications, contraindications, warnings and precautions, refer to the product Instructions for Use or contact your AMS representative. This document is written for professional medical audiences. Contact AMS for lay publications. AMS periodically updates product literature. If you have questions regarding the currency of this information please contact AMS. The Difference is in the Data Author/Congress Study Details Pickens et al at AUA month prospective (n=120) Kennelly et al ICS month prospective (n=82) Urwin BAUS weeks prospective (n=28) Pickens ICS month prospective (n=60) Moore et al AAGL weeks retrospective (n= 60) Success Rate * Data on file at AMS. Cure defined as no pad usage Negative CST 86.0% Dry defined as negative CST or positive response to Q3 on UDI % AMS Women s Health Solutions MiniArc Single Incision Sling Monarc Subfascial Hammock SPARC Sling BioArc TO Subfascial Hammock Elevate Posterior Defined as no pad usage or complaints of any leaking 93.2% Objective & subjective (dry defined as negative CST or patient response) American Medical s, Inc. World Headquarters Bren Road West Minnetonka, MN USA U.S. Toll Free: Phone: American Medical s, Inc. All rights reserved. Printed in USA. Elevate Anterior Apogee Vaginal Vault Perigee Transobturator Anterior Prolapse Repair American Medical s Europe B.V. Straatweg 66H 3621 BR Breukelen THE NETHERLANDS Phone: F (03/10) The Simple Solution for Female Stress Urinary Incontinence Robert D. Moore, D.O., Atlanta Urogynecology Associates For physicians who have not felt comfortable with TVT or TOT, this procedure will open the door for them to be able to treat their patients who have SUI. MiniArc is the simplest and easiest sling to place on the market to date. It is safe, with early results reflecting equivalent cure rates to TVT and TOT slings. The MiniArc requires no groin incision, just one small vaginal incision. The self-fixating tips provide excellent fixation with the same pull-out strength offered by Monarc.

6 CONTINENCE SOLUTIONS One Slim Needle One Incision ordering information Description US International Order Number Order Number One Simple Solution for Stress Urinary Incontinence MiniArc Single-Incision Sling MiniArc Box of NA Single-inci sion sling sy stem Summary of Warnings, Precautions and Contraindications for the MiniArc As with any surgical procedure, inherent risks are present. Although rare, some of the most severe risks with sling procedures include infection, erosion, and vessel or urethra perforation. Some of the most common risks include urinary tract infections, urge symptoms and urinary retention. Sling procedures should not be performed on pregnant patients. For a complete list of indications, contraindications, warnings and precautions, refer to the product Instructions for Use or contact your AMS representative. This document is written for professional medical audiences. Contact AMS for lay publications. AMS periodically updates product literature. If you have questions regarding the currency of this information please contact AMS. The Difference is in the Data Author/Congress Study Details Pickens et al at AUA month prospective (n=120) Kennelly et al ICS month prospective (n=82) Urwin BAUS weeks prospective (n=28) Pickens ICS month prospective (n=60) Moore et al AAGL weeks retrospective (n= 60) Success Rate * Data on file at AMS. Cure defined as no pad usage Negative CST 86.0% Dry defined as negative CST or positive response to Q3 on UDI % AMS Women s Health Solutions MiniArc Single Incision Sling Monarc Subfascial Hammock SPARC Sling BioArc TO Subfascial Hammock Elevate Posterior Defined as no pad usage or complaints of any leaking 93.2% Objective & subjective (dry defined as negative CST or patient response) American Medical s, Inc. World Headquarters Bren Road West Minnetonka, MN USA U.S. Toll Free: Phone: American Medical s, Inc. All rights reserved. Printed in USA. Elevate Anterior Apogee Vaginal Vault Perigee Transobturator Anterior Prolapse Repair American Medical s Europe B.V. Straatweg 66H 3621 BR Breukelen THE NETHERLANDS Phone: F (03/10) The Simple Solution for Female Stress Urinary Incontinence Robert D. Moore, D.O., Atlanta Urogynecology Associates For physicians who have not felt comfortable with TVT or TOT, this procedure will open the door for them to be able to treat their patients who have SUI. MiniArc is the simplest and easiest sling to place on the market to date. It is safe, with early results reflecting equivalent cure rates to TVT and TOT slings. The MiniArc requires no groin incision, just one small vaginal incision. The self-fixating tips provide excellent fixation with the same pull-out strength offered by Monarc.