FDA Device (PMA) Approvals: ASPIRE, GORE VIABAHN
FDA BRIEF: Week of January 30, 2017
ASPIRE Cristalle Digital Breast Tomosynthesis Option
Fujifilm Medical Systems, Stamford, CT, USA
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.
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
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