2
[absolute MLA gain]; clinical improvement at one year
(when available) +/- 2 months, defined as reported by
patients (less swelling and/or pain in the treated limb); and
patency by duplex ultrasound at one month and 1 year
when data was available.
Patient Demographics
The mean age of patients was 61.9 years, and 60.7% were
females. Eighteen percent of patients had a history of deep
vein thrombosis (DVT) and 13.1% of patients had history
of pulmonary embolism (PE). The majority of patients
did not have a history of smoking, diabetes, or peripheral
arterial disease, nor presented with a hypercoagulable state
or deep vein reflux. A majority of patients presented with
heaviness or pain and swelling of the leg. One patient had
an IVC filter.
Patient Demographics
N (N=61)
Mean
Range
Age
Female
37
60.9
23.0-85.0
Male
24
63.3
24.0-87.0
ALL
61
61.9
23.0-87.0
BMI (kg/m2)
Female
37
32.0
19.1-45.3
Male
24
33.5
20.5-49.2
ALL
61
32.6
19.1-49.2
Variable
N (N=61)
%
History of DVT
No
50
82.0%
Yes
11
18.0%
Variable
N (N=11)
%
Location of DVT
*
4
36.4%
Left popliteal
2
18.2%
Bilateral Unnamed
1
9.1%
Left Axillary
1
9.1%
Left Lower Extremity
3
27.3%
Variable
N (N=61)
%
History of PE
No
53
86.9%
Yes
8
13.1%
Hypertension
No
26
42.6%
Yes
35
57.4%
Smoking
No
40
65.6%
Yes
21
34.4%
Diabetes Mellitus
No
52
85.2%
Yes
9
14.8%
Peripheral Arterial
Disease
No
58
95.1%
Yes
3
4.9%
Inferior Vena Cava
Filter
No
60
98.4%
Yes
1
1.6%
Deep Vein Reflux
No
43
70.5%
Yes
9
14.8%
*
9
14.8%
Heaviness/Pain in Leg No
18
29.5%
Unilateral
43
70.5%
Bilateral
0
0.0%
Swelling in Lower Leg No
14
23.0%
Unilateral
47
77.0%
Bilateral
0
0.0%
Hypercoagulation State No
60
98.4%
Yes
1
1.6%
*not recorded
Procedural Variables
Balloons used for pre-dilatation ranged from 12-14 mm
in diameter and were inflated to 3-14 atm. Balloons used
for post-dilatation ranged from 12-18 mm in diameter and
were inflated to 2-20 atm. All patients received a stent.
Results
There were no intraprocedural complications for 96.8% of
patients treated with
Atlas
®
gold
PTA Dilatation Catheter.
One patient experienced stent migration during stent
deployment, which was unrelated to the use of
Atlas
®
gold
PTA Dilatation Catheter. The IVUS MLA at the
confluence post-stenting was markedly improved.
Intraprocedural Complications
Variable
N (N=61)
%
No intraprocedural complications
60
96.8%
Distal embolization (causing
documented PE)
0
0%
Acute thrombotic occlusion
0
0%
Balloon rupture
0
0%
Balloon getting stuck on stent
0
0%
Stent disruption or dislodgement with
balloon insertion
0
0%
Stent disruption not related to study
device
1
1.6%
Intraprocedural IVUS Measurements
Variable
N (patients
with IVUS
recorded)
Mean
Range
MLA at
compression (mm)
40
72.0
27.0-174.0
Percent
compression by
IVUS
40
66.2
15.9-91.1
IVUS Common Iliac
Vein Area Ipsilateral
Distal Reference
(mm
2
)
40
226.7
85.0-455.0
IVUS Post-Stent
Area at Confluence
(mm
2
)
39
218.8
87.0-433.0
Conclusion
The
Atlas
®
gold
PTA Dilatation Catheter met 100%
freedom from intraprocedural adverse events related to
the study device, and exceeded the 95% benchmark for
the primary safety endpoint. No balloon ruptures, vessel
perforations, or balloon-related intravascular events
occurred. At one month and one year there were no
adverse events related to
Atlas
®
gold
PTA Dilatation
Catheter use, with marked symptom improvement in the
majority of patients. Additionally, imaging analysis showed
that stent dilatation yielded excellent stent expansion at
the level of compression and the MLA obtained was nearly
equivalent to the reference diameter.
Warranty
Bard Peripheral Vascular warrants to the first purchaser of
this product, that this product will be free from defects in
materials and workmanship for a period of one year from
the date of first purchase and liability under this limited
product warranty will be limited, to repair or replacement
of the defective product, in Bard Peripheral Vascular's sole
discretion, or refunding your net price paid. Wear and tear
from normal use or defects resulting from misuse of this
product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW,
THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF
ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. IN NO
EVENT WILL BARD PERIPHERAL VASCULAR BE
LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL
OR CONSEQUENTIAL DAMAGES RESULTING FROM
YOUR HANDLING OR USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied
warranties, incidental or consequential damages. You
may be entitled to additional remedies under the laws of
your country.
An issue or revision date and revision number
for these instructions are included for the user’s
information on the last page of this booklet.
In the event 36 months have elapsed between this date
and product use, the user should contact Bard Peripheral
Vascular to see if additional product information is
available.
