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CMF surgery - Resorbable osteosynthesis SonicWeld Rx

Craniomaxillofacial Surgery

SonicWeld Rx®

SonicWeld Rx® is a revolutionary technique for use in craniomaxillofacial osteosynthesis. It combines highly advanced ultrasound technology with resorbable implants to provide extremely stable fixation and completely eliminate the need for a second operation.
The procedure is simple: resorbable meshes are heated up, shaped to fit the application site and then fixed in place with SonicPins inserted into predrilled holes. This is done with a sonotrode that liquefies the pins, thus causing them to bond with the meshes and penetrate into the bone cavities to anchor themselves securely.
The method is clinically certified and validated and very patient -friendly as well. The implants degrade through natural hydrolysis in a controlled process. SonicWeld Rx® is primarily stable, convenient, fast, easy and safe. Designed for cranial fixation, ideal for pediatric trauma, and indicated also for cancellous bone structures.
 

The polymers

Two resorbable polymers for osteosynthesis, PDLLA and PLLA-PGA, have been well-established in craniomaxillofacial surgery.

  • Resorb x® polymer is a 100% Poly-D,L-Lactic Acid (PDLLA).
  • Resorb xG polymer consists of 85% Poly-L-Lactic Acid (PLLA) and 15% Poly Glycolic Acid (PGA).

Both resorbables maintain the majority of their strength for 8-10 weeks, allowing complete fracture healing and bone regeneration. 

The core of the degradation process: The complex polymer chains absorb the water contents (H2O molecules) of surrounding body fluids through a process called “hydrolysis”. The stored water initiates the degradation process by continuously breaking down the long polymer chains into ever shorter structures or simpler molecules. Metabolic pathways subsequently transform the molecules into carbon dioxide and water; both of these compounds are discharged naturally.

SonicWeld Rx® II

SonicWeld Rx®, the unique ultrasound technology for insertion of resorbable SonicPins. Watch the video to learn about the 2nd generation of SonicWeld Rx®.

SonicWeld Rx® Surgical Technique – Craniosynostosis

Watch the video and learn about the surgical technique for the treatment of a craniosynostosis with the SonicWeld Rx® system and our resorbable implants.

The procedure step by step

SonicWeld-Rx®-System

Easiest handling and attractive design for error-free working

Indications:

  • Osteosyntheses in non-load-bearing craniomaxillofacial areas
  • Craniofacial corrective osteotomies, for example, syndrome patients, fronto-orbital advancement in the non-load-bearing craniomaxillofacial area
  • Pediatric neurosurgery
  • Preprosthetic augmentation

Features:

a) of the unit itself:

  • Simple and elegant design
  • Round corners
  • Recesses for safe holding of the device
  • Two sockets for the optional connection of two handpieces
  • A preset power level
  • Opportunity to choose the individual system language

b) of the handpiece:

  • Ergonomically designed handpiece
  • Finger activation
  • Visual and acoustic feedback during activation
  • Autoclavable

Benefits:

a) of the unit itself:

  • Easy to clean
  • Secure grip of the device during transport
  • Alternating work with two connected sonotrodes is possible
  • Optimal system setting
  • User-friendly operation
  • User-friendliness is given by easy to understand spoken instructions and icons

b) of the handpiece:

  • Handpiece lies securely in the hand
  • Handpiece is equally suited for left-handed and right-handed persons
  • Feedback during activation guarantees best functionality
  • Guaranteed biocompatibility for up to 250 sterilization cycles

SonicPins

Easiest application - maximum reliability!

Indications:

  • Osteosyntheses in non-load-bearing craniomaxillofacial areas
  • Craniofacial corrective osteotomies, for example, syndrome patients, fronto-orbital advancement in the non-load-bearing craniomaxillofacial area
  • Pediatric neurosurgery
  • Preprosthetic augmentation

Features:

  • Supplied sterile
  • Optimized pin geometry guarantees easy insertion of the pins into the bone structure together with best anchoring
  • SonicPins Rx can be inserted into the bone in a straightforward movement
  • Time-consuming tapping is eliminated completely
  • Self-retaining pin head on the sonotrode tip
  • Packaged in 2, 5 or 20 units
  • Can be applied from color-coded clip magazines

Benefits:

  • Extremely simple, intuitive application
  • No dislocation of the bone fragments, no shearing of screw heads!
  • Maximum anchorage in the bony cavities of the trabecular structure
  • Full compatibility of plates/meshes with the SonicPins Rx: every SonicPin Rx is compatible with every Resorb-X® implant
  • Disposition of the SonicPins in strict adherence with expected consumption
  • No unwanted falling off from the sonotrode tip
  • Ready-to-use: remove from outer packaging and apply! 
  • No risk of mix-ups
     

Resorb-x®- und Resorb-xG-implants

Maximum cleanliness and functionality for indications where it counts!

Indications:

  • Osteosyntheses in non-load-bearing craniomaxillofacial areas
  • Craniofacial corrective osteotomies, for example, syndrome patients, fronto-orbital advancement in the non-load-bearing craniomaxillofacial area
  • Pediatric neurosurgery
  • Preprosthetic augmentation

Features:

  • Manufactured from the polymer blends PDLLA and PDLLA/PGA
  • Manufactured under cleanroom conditions for maximum patient safety
  • Packaged singly and sterile
  • Huge variety of different geometries, sizes and thicknesses
  • Membranes and foils in minimum diameters of 0.1 – 0.3 mm 
  • Osteosynthesis plates and meshes in 0.6 – 1.5 mm
  • Round corner geometry
  • Partly already 3D pre-bent

Benefits:

  • Full compatibility of plates/meshes with the SonicPins Rx - every implant can be combined with every SonicPin Rx
  • Round corner geometry guarantees best tissue compatibility
  • Best contourability after heating in the Xcelsior water bath
  • Ready-to-use: easy to remove from outer packaging and apply!
  • Always the ideal implant for every application

Xcelsior water bath

Simply ingenious, as ingeniously simple!

Indications:

  • Osteosyntheses in non-load-bearing craniomaxillofacial areas
  • Craniofacial corrective osteotomies, for example, syndrome patients, fronto-orbital advancement in the non-load-bearing craniomaxillofacial area
  • Pediatric neurosurgery
  • Preprosthetic augmentation

Features:

  • Preheating of Resorb-x® implants under the influence of heat
  • Sterile liquid acts as heating medium
  • Sterilizable cover and hood for working close to the patient in the operating field
  • Extremely simple, intuitive application

Benefits:

  • Best contourability of the implants for seamless adaptation to the existing bone surface
  • Cooled, the resorbable implants remain three-dimensionally stable
  • High efficiency, even for large-area of stronger implants
  • The risk of maloperation is largely excluded
  • Environment-friendly - durable, reliable and safe working with the Xcelsior