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The IlluminOss System

The IlluminOss System

Overview

IlluminOss Medical produces minimally invasive conforming orthopedic implants leveraging it’s proprietary bone stabilization technology, the IlluminOss System. Through the unique combination of balloons, light activated monomers and flexible catheters, IlluminOss has created the world’s first patient conforming intramedullary implant. The IlluminOss system has been safely and effectively used worldwide in thousands of patients since 2010 for a wide variety of clinical indications.

The Technology

IlluminOss provides the world’s first minimally invasive, patient conforming polymer implant for fracture repair and stabilization. The IlluminOss System incorporates a PET or Dacron® balloon catheter that is delivered through a small pathway into the intramedullary canal transiting the fracture site. Using a standard syringe, IlluminOss’ light activated, biocompatible monomer is infused into the balloon, causing it to expand, fill and conform to the patients intramedullary canal. Only upon the activation of IlluminOss’ visible light source will the monomer infused balloon begin to cure. The cured implant provides both longitudinal strength and rotational stability to allow for fracture repair and stabilization. Should ancillary fixation devices be needed they can be placed anywhere along the implant.

Balloon Angioplasty Catheter

Balloon Angioplasty Catheter

Light Cured Liquid Monomer Similar to Dental Cement

Light Cured Liquid Monomer Similar to Dental Cement

Minimally Invasive Patient Conforming Orthopedic Implant

Minimally Invasive Patient Conforming Orthopedic Implant

The System

Light Cured Liquid Monomer Similar to Dental Cement

The IlluminOss System Components: Balloon Catheter

Light Cured Liquid Monomer Similar to Dental Cement

IlluminOss Photodynamic Liquid Monomer

Light Cured Liquid Monomer Similar to Dental Cement

Photodynamic Curing System

Key Advantages

The IlluminOss System offers significant advantages to surgeons for treating a variety of fractures.

  • Minimally invasive.
  • Monomer is infused & fully contained within the balloon.
  • Balloon conforms to the canal.Cures on demand through the application of visible light.
  • Implant provides rapid stability & strength to the fracture & compromised bone.
  • Radiolucent for improved visibility of the cortex.
  • Radiopaque spiral markings provide a 3D profile of the implant.
  • Implants can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation.

Significant Patient benefits may include:

  • Small incisions minimizing soft tissue injury.
  • Short Procedure times.
  • Reduced length of hospital stays.
  • Reduction in Post Operative pain.
  • Less use of Post Operative pain medications.
  • Faster return to functional and daily living activities.

Indications & Approvals

US Indication: The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.

EU Indication: The Photodynamic Bone Stabilization System is indicated for use in fracture alignment reduction. It provides stabilization for bone fractures using a minimally invasive technique in which the bone is not subjected to significant weight bearing forces. This IlluminOss procedure pack is intended for use in treatment of the metacarpal, phalange, clavicle, radius, ulna, distal radius, olecranon and fibula. It is also indicated for the treatment of impending and actual pathological fractures of the humerus from metastatic bone disease.

For more detailed procedural information including Warnings, Cautions, Risks & Contraindications, please see the respective IlluminOss IFU’s Surgical Technique Guide, or Package insert.