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Summary of Contents for Boston Scientific Solyx
- Page 1 Solyx ™ Single-Incision Sling System Product Overview Directions for Use Ordering Information Clinical/Scientific Data Regulatory Information Reimbursement Guide Product Review for the Purchasing Committee...
- Page 2 Solyx Single-Incision Sling System ™ Product Overview How can we continue to innovate our family of mid-urethral slings that have already been the products of choice for nearly 800,000 patients? By creating the same reliable mesh in an easy-to- see, optical blue color. So whatever your preferred surgical approach, Advantage ™...
- Page 3 Solyx Single-Incision Sling System ™ Mesh carrier • The barb design is intended to track smoothly through tissue Mid-line marker • Snap-fit to delivery device tip is designed Designed to facilitate to prevent premature guidance for accurate carrier slip-off placement...
- Page 4 1. Moalli PA, Papas N, Menefee S, et al. Tensile properties of five commonly used mid-urethral slings relative to the TVT. Int Urogynecol J Pelvic Floor Dysfunct. 2008 May;19(5):655-63. 2. Heat sealed mid-section 3. Advantage Blue mesh available for Advantage Fit, Advantage, Lynx, Obtryx II and Solyx Product Review for the Purchasing Committee...
- Page 5 May 11, 2018 Dear Valued Customer, Thank you for your inquiry regarding the Solyx ™ Blue SIS System. This information is provided in response to your direct request regarding the regulatory status of these products and may not be used for any other purpose without the expressed written permission of Boston Scientific.
- Page 6 January 8, 2018 Dear Valued Customer, Thank you for your inquiry regarding Boston Scientific product, Solyx SIS™ System. This information is provided in response to your direct request regarding the regulatory status of these products and may not be used for any other purpose without the expressed written permission of Boston Scientific.
- Page 7 Solyx Single-Incision Sling System ™ FDA 510K Clearance Letter Product Review for the Purchasing Committee...
- Page 8 Solyx Single-Incision Sling System ™ Product Review for the Purchasing Committee...
- Page 9 Solyx Single-Incision Sling System ™ Indications for Use Statement Product Review for the Purchasing Committee...
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Page 10: Table Of Contents
HoW sUPPlIeD.................. 5 Solyx ™ oPeRaTIonal InsTRUCTIons............5 Prior to Use..................5 SIS System Figure 1: Solyx™ SIS System and Solyx Blue SIS Solyx Blue System ..................6 WaRnInG ..................6 Steps for Use................. 6 SIS System Incision and Dissection ............... 6 Figure 2: Dissection Pathway .......... -
Page 11: Warning
The Solyx and Solyx Blue SIS (Single Incision Sling) Systems (e.g. diabetes, smoking status, estrogen status, pelvic are sterile single use systems each consisting of one (1) delivery floor radiation exposure, etc.), age, pelvic floor myalgia,... -
Page 12: Adverse Events
Prior to Use the delivery device tip into the mesh carrier (See Figure 3). The Solyx and Solyx Blue SIS Systems are supplied sterile and are Note: The mesh carrier should be pushed onto the delivery intended for single patient use only. Carefully examine the system... -
Page 13: Precaution
Solyx Single-Incision Sling System ™ PReCaUTIon Hold each side of the mesh carrier (See Figure 3) to avoid possible glove puncture. figure 5. Flush With Delivery Device Shoulder figure 3: Mesh assembly Placement onto Delivery Device Outside Curve Of Delivery Device figure 6. -
Page 14: Warranty
Recyclable Package WaRRanTY Envase reciclable Emballage recyclable Boston Scientific Corporation (BSC) warrants that reasonable Wiederverwertbare Verpackung care has been used in the design and manufacture of this Confezione riciclabile instrument. This warranty is in lieu of and excludes all other Recyclebare verpakking Embalagem Reciclável... - Page 15 Do not use if package is damaged. Recyclable Package © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. Dual manufactured product; no change in content as of January 22, 2018. For current version refer to the DFU packaged with the product.
- Page 16 Clinical/Scientific Data Lead Author Title Publication/Conference Year Long term follow up of the Solyx Single-Incision Sling in the treatment of female Serels S, et al. Open Journal of Urology 2014 stress urinary incontinence (SUI) Safety and efficacy of the Solyx Single-Incision Sling System for the treatment of UroToday International Serels S, et al.
- Page 17 Solyx Single-Incision Sling System ™ Reimbursement Guide Is this product reimbursable by insurance? The procedures for which it is used are reimbursable. Billing guides with respective coding and estimated Medicare National Average reimbursement for sling operation for stress incontinence procedures are available online at www.bostonscientific.com/reimbursement.
- Page 18 The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies.
- Page 19 Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and or its affiliates. All rights reserved. Instructions prior to using this product. All trademarks are the property of their respective owners. All images are owned by Boston Scientific. WH-200803-AD MAY 2018...
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