• Sterile and Compliant Lens - Canada
System Image FDA film(1)

Sterile and Compliant Lens - Canada

Sterile and compliant lens for Eagle V1.2 Imaging System™ with LEXAN™ 8040 Film

Approximately 1 in 5 women still require a second surgery, following their index breast conserving surgery, in order to achieve clean surgical margins.

The Eagle V1.2 Imaging System™ is an investigational intra-operative fluorescence imaging device, which will be used to visualize the distinct red fluorescence produced by cancer cells, against the natural green fluorescence of healthy breast tissues.

PRODUCT SOLUTION: 

 

Our FDA approved LEXAN™ 8040 film is used as a disposable lens cover placed on the system to overcome the high refractive index of glass which was causing distortions in the images seen in real time.

Extensive testing was executed on different kind of plastics, on:

  • Light refraction performance
  • Imperfections (black specs)
  • Compliant to FDA regulations and meets USP-VI criteria
  • Optical clarity
  • Bio-compatibility (ISO 10993)
  • Thermoformability
  • Autoclave stability

 

* The Eagle V1.2 Imaging System™ is still in phase III clinical trial

PRODUCT BENEFITS:

  • Excellent light transmission with evenly and efficiently spread of light
  • Very easy to form and shaped in any preferable design

 

  • Complies with FDA regulations and meets USP-VI criteria
  • Meets packaging standards for efficient sterilisation
Tipo de recurso
Região
Idioma
TITULO Tipo de recurso Idioma Região

Partners / Distributors:

Client:

  • ABOUT SBI ALApharma

It is their mission to address this requirement in care - by providing breast cancer surgeons with the ability to visualize residual disease in real-time during index breast cancer surgeries. Driven by this mission, SBI ALApharma Canada Inc. is conducting a pivotal Phase III clinical trial to assess the use of fluorescence-guided surgery for breast cancer patients.

Partner:

SBI ALApharma Canada Inc. | LinkedIn