FDA BRIEF: Week of August 15, 2016

SAPIEN XT and SAPIEN 3 Transcatheter Heart Valves 

 Edwards Lifesciences, Irvine, CA, USA

EXPANDED INDICATION FOR USE:

Relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

ADDRESSING UNMET NEED:

• Aortic valve stenosis increases with age –  need for heart valve replacement to improve blood flow through their aortic valve
• Gold standard –  open-heart surgery.  ~ 30% patients at “intermediate risk”
• Transcatheter aortic valve replacement (TAVR) minimally invasive procedure
• First time in  U.S. for a transcatheter aortic valve  use in intermediate risk patients
• Significantly expands access to patients for less invasive procedure

REG. PATHWAY:

• PMA approved in 2015
• Supplemental PMA for expanded indication
• Priority Review status because availability is in the best interest of the patients

EFFECTIVENESS:

• First Study: Randomized, intermediate risk aortic stenosis patient, SAPIEN3 TAVR (n=1,011) vs traditional aortic valve replacement during open-heart surgery (n=1,021)
• Second study : Intermediate risk patients (n=1,078)  implanted with the Sapien 3 vs.  surgical control patients in study 1
• Primary endpoint:  Non-hierarchical composite of all-cause death, all stroke, or aortic insufficiency (AI) ≥ moderate at 1 year.s 13.0% vs. 23.2%
• Sapien 3 group showed significantly lower rates of mortality (1.1%), disabling stroke at 30 d (1.0%), and moderate or severe aortic regurgitation after one year
• Also improvement in valve hemodynamics  – improvements in 6MWT distance, NYHA classification and QoL

SAFETY:

• Potential risk: Serious complications from device/implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker
• Contraindication: Patients who cannot tolerate blood thinning medication, being treated for a bacterial or other infection

POST-APPROVAL REQUIREMENT: Monitor safety and effectiveness in patients in both studies for 10 years.

LABEL

 

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Zika Virus Emergency Use Authorization

ZIKV DetectTM IgM Capture ELISA

InBios International, Seattle, WA, USA

INTENDED USE: Presumptive detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria  and/or CDC Zika virus epidemiological criteria. Intended for use in US CLIA certified laboratories, or by similarly qualified non-U.S. laboratories

REG PATHWAY: Emergency Use Authorization (EUA)

DEVICE DESCRIPTION:

• Uses purified antibody specific for human IgM that is immobilized on a test plate to capture IgM antibodies from human specimen
• Kit contains:  Coated Microtiter Test Strips for IgM, ZIKV Sample Dilution Buffer, Ready-To-Use ZIKV Recombinant Antigen for IgM (Zika Ag), Cross-reactive Control Antigen for ZIKV IgM (CCA),  Normal Cell Antigen for ZIKV IgM,  100X Conjugate, Conjugate Diluent for ZIKV,  10X Wash Buffer, Liquid Tetramethylbenzidine Substrate, Stop Solution, ZIKV IgM Positive Control:&  ZIKV IgM Negative Control

LIMITATIONS:

• Possibility of false positive results
• Additional testing and/or consideration of test results for other patient-matched specimens, using the latest CDC guideline

LABEL

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