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
fujifilm

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.

REG PATHWAY: PMA

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

DESCRIPTION:

  • 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

EFFECTIVENESS & SAFETY:

  • 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

gore

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

REG PATHWAY: PMA

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

DESCRIPTION:

  •  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

EFFECTIVENESS & SAFETY:

  • 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

LABEL


 

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