FDA BRIEF: Week of January 30, 2017

FDA approved

ASPIRE Cristalle Digital Breast Tomosynthesis Option

Fujifilm Medical Systems, Stamford, CT, USA

ASPIRE Cristalle by FUJIFILM Medical Systems U.S.A., Inc

INDICATION FOR USE: Acquires and generates full-field digital mammograph (FFDM) and Digital Breast Tomosynthesis (DBT() images, and is intended for use in the screening and diagnosis of breast cancer.


  • Device Generic Name: Digital Breast Tomosynthesis Mammography System Device
  • Product Code: OTE


  • 2 main subsystems & 3 operating modes
  • Main subsystems 1) The FDR-3500DRLH X-ray Stand (Exposure Unit) integrated x-ray delivery system   and 2) The FDR-3000AWS Acquisition Workstation (AWS) controls the exposure unit to acquire and process mammographic images.
  • Operation modes to capture 2D and 3D images


  • Multiple-reader multiple-case (MRMC) study:  Reader performance on average increases 0.053 AUC ROC units with two-sided 95% CI: 0.028, 0.078; p < 0.01.
  • Combined with physical laboratory test results and sample image evaluation, ASPIRE Cristalle DBT option used as an adjunct is superior to FFDM alone
  • Device Risks: Patient direct harm is minimal. Risk posed similar to other screening and diagnostic mammography devices.

Approval Order

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

W. L. Gore & Associates, Flagstaff, AZ, USA


INDICATION FOR USE:  Treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm – 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation


  • Generic name: Stent, Iliac
  • Product Code: NIO


  •  Surgical grade stainless steel balloon expandable stent and fluoropolymer graft
  • The CBAS® Heparin Surface consists of stable, covalent, end-point attached heparin of porcine origin
  • Endoprosthesis premounted on delivery system equipped with balloon
  • Delivery system can be used for initial stent placement and post stent dilatation


  • Single prospective, multicenter, single-arm clinical study e in patients with de novo or restenotic lesions in the common and / or external iliac arteries (n=132)
  • Primary endpoint:   device- or procedure-related death within 30 d, myocardial infarction (MI) within 30 d; amputation above the metatarsals in the treated leg, resulting from a vascular event or target lesion revascularization (TLR) within 9 mo
  • No device- or procedure- related deaths and no MIs within 30d, no major amputations within 9 mo, TLR in 3 subjects



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