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• For landmarks above the umbilicus the calculated temperature rise was 0.9 °C for a
whole body average SAR value of 2.0 W/kg and a continuous scan time of
15 minutes with perfusion cooling and uncertainty.
• For landmarks below the umbilicus the calculated temperature rise was 3.47 °C for
a whole body average SAR value of 0.41 W/kg and a continuous scan time of
15 minutes with perfusion cooling and uncertainty.
Image Artifact (Per ASTM F2119)
The image artifact extends approximately 5 mm from the perimeter of the device
diameter and 1.5 mm beyond each end of the length of the uncoated ELUVIA Stent
when scanned in non-clinical testing using the sequence, Spin Echo. With a Gradient
Echo sequence the image artifact extends 12 mm from the perimeter of the device
diameter and 1.8 mm beyond each end of the length of the stent with both sequences
partially shielding the lumen in a 3.0 Tesla Achieva (Achieva Upgrade), Philips Medical
Solutions, software version Release 2.5.3.0 2007-09-28 MR system with a Quadrature
transmit/receive head coil. Image artifacts in a body birdcage coil are similar to the
image artifacts in the transmit/receive CP head coil.
Recommendations
It is recommended that patients register the conditions under which the implant
can be scanned safely with the MedicAlert Foundation (www.medicalert.org) or
equivalent organization.
7. ADVERSE EVENTS
Potential adverse events which may be associated with the use of a peripheral stent
include but are not limited to:
• Allergic reaction (to drug/polymer, contrast, device or other)
• Bleeding/Hemorrhage
• Death
• Embolism (air, plaque, thrombus, device, tissue, or other)
• Hematoma
• Hypotension/hypertension
• Ischemia/necrosis
• Need for additional intervention or surgery
• Renal insufficiency or failure
• Restenosis of stented artery
• Sepsis/infection
• Thrombosis/thrombus
• Vasospasm
• Vessel occlusion
• Vessel trauma (perforation, pseudoaneurysm, injury, rupture, and dissection)
Potential adverse events not captured above that may be unique to the Paclitaxel
drug coating:
• Allergic/immunologic reaction to drug (paclitaxel or structurally-related
compounds) or the polymer stent coating (or its individual components)
• Alopecia
• Anemia
• Gastrointestinal symptoms
• Hematologic dyscrasia (including leukopenia, neutropenia, thromboctyopenia)
• Hepatic enzyme changes
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MB Drawing 50573139
• Histologic changes in vessel wall, including inflammation, cellular damage or necrosis
• Myalgia/Arthralgia
• Peripheral neuropathy
• There may be other potential adverse events that are unforeseen at this time
8. CLINICAL STUDIES
8.1 Summary of the Meta-Analysis: Late Mortality Signal for
Paclitaxel-Coated Devices
A meta-analysis of randomized controlled trials published in December 2018 by
Katsanos et. al. identified an increased risk of late mortality at 2 years and beyond for
paclitaxel-coated balloons and paclitaxel-eluting stents used to treat femoropopliteal
arterial disease. In response to these data, FDA performed a patient-level
meta-analysis of long-term follow-up data from the pivotal premarket randomized
trials of paclitaxel-coated devices used to treat femoropopliteal disease using available
clinical data through May 2019. The meta-analysis also showed a late mortality signal in
study subjects treated with paclitaxel-coated devices compared to patients treated with
uncoated devices. Specifically, in the 3 randomized trials with a total of 1090 patients
and available 5-year data, the crude mortality rate was 19.8% (range 15.9% - 23.4%) in
patients treated with paclitaxel-coated devices compared to 12.7% (range 11.2% - 14.0%)
in subjects treated with uncoated devices. The relative risk for increased mortality at
5 years was 1.57 (95% confidence interval 1.16 - 2.13), which corresponds to a 57% relative
increase in mortality in patients treated with paclitaxel-coated devices.
As presented at the June 2019 FDA Advisory Committee Meeting, an independent
meta-analysis of similar patient-level data provided by VIVA Physicians, a vascular
medicine organization, reported similar findings with a hazard ratio of 1.38 (95% confidence
interval 1.06 - 1.80). Additional analyses have been conducted and are underway that are
specifically designed to assess the relationship of mortality to paclitaxel-coated devices.
The presence and magnitude of the late mortality risk should be interpreted with
caution because of multiple limitations in the available data, including wide confidence
intervals due to a small sample size, pooling of studies of different paclitaxel-coated
devices that were not intended to be combined, substantial amounts of missing study
data, no clear evidence of a paclitaxel dose effect on mortality, and no identified
pathophysiologic mechanism for the late deaths.
Paclitaxel-coated balloons and stents improve blood flow to the legs and decrease the
likelihood of repeat procedures to reopen blocked blood vessels compared to uncoated
devices. The benefits of paclitaxel-coated devices (e.g., reduced reinterventions) should
be considered in individual patients along with potential risks (e.g., late mortality).
In the IMPERIAL Trial such mortality signal has not been found at 2 years.
Kaplan Meier mortality estimates at 2 years are 7.1% (95% CI: 4.1%, 10.0%) for
the ELUVIA treatment device and 8.0% (95% CI: 3.7%, 12.4%) for the Zilver PTX
paclitaxel-coated control device, which fall within the expected mortality rates for
this patient population.
9. HOW SUPPLIED
The ELUVIA Drug-Eluting Vascular Stent System is supplied sterile inside a pouch.
The device is sterilized via Ethylene Oxide.
Device Details
Do not use if package is damaged or unintentionally opened before use.
Do not use if labeling is incomplete or illegible.
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