Solyx?

Single-Incision Sling System

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Solyx product image
Solyx product image
Solyx product image
Mesh Carrier with Delivery Device Tip -?The barb design is intended to track smoothly through tissue. Snap-fit delivery device is designed to help prevent premature carrier slip-off.
Delivery Device - Designed to seat carrier where placed. Ergonomic handle design.

Single incision sling system designed to offer a procedure with fewer steps and reduced dissection. The mesh assembly is designed to be placed away from critical structures, such as the obturator bundle, and the carrier snap-fit on the delivery device tip is designed to facilitate control during placement. Available with Advantage? clear mesh or Advantage Blue mesh.

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Product Details

Mesh Carrier and Assembly

  • The barb design is intended to track smoothly through tissue
  • Snap-fit delivery device is designed to help prevent premature carrier slip-off
  • Mesh length is 9cm
  • Mesh assembly placement is designed to be away from critical structures, such as the obturator bundle

Delivery Device

  • Designed to seat carrier where placed
  • Ergonomic handle design
  • Mid-line marker designed to facilitate guidance for accurate placement

Ability to Tighten

  • Sling is tensioned by delivery device advancement and retraction
  • Carrier snap-fit on delivery device tip designed to facilitate control during placement
  • Note: Once the carrier is deposited in the tissue, it is not designed to be reconnected onto the shaft tip for additional tension/adjustment.

De-Tanged Polypropylene Material

  • Designed to Reduce Irritation. The polypropylene mesh is de-tanged in the suburethral portion to potentially reduce irritation to the urethral wall.

 

  • Resists Deformation The suburethral portion of the mesh is de-tanged to potentially resist deformation.
 

Ordering Information

Order Number UPN Description Quantity
850700 M0068507000 Solyx SIS System 1 Delivery Device and 1 Mesh Assembly
850701 M0068507010 Solyx Blue Single Incision Sling System 1 Delivery Device and 1 Mesh Assembly

Each System includes One (1) Delivery Device and One (1) Mesh Assembly

 

Reimbursement

 

522 Post-Market Clinical Study Results

NOW AVAILABLE

36-Month Data from Solyx Single Incision Sling System 522 Study

The Solyx Single-Incision Sling System 522 post-market clinical study is a prospective, parallel cohort, non-inferiority study to assess the safety and effectiveness of a single incision sling. This study evaluated the Solyx Single-Incision Sling (SIS) System as compared to the Obtryx II Transobturator Mid-Urethral Sling System, an approach considered one of the gold standards for the treatment of stress urinary incontinence (SUI). The Solyx SIS system achieved treatment success meeting all primary and secondary endpoints, demonstrating that it was non-inferior to the transobturator mid-urethral sling procedure for successful treatment of these patients at 3-year follow-up.
 

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