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Original research

Sofia intermediate catheter and the SNAKE


technique: safety and efficacy of the Sofia catheter
without guidewire or microcatheter construct
Jeremy J Heit,1 Johnny HY Wong,1 Adrienne M Mofaff,1 Nicholas A Telischak,2
Robert L Dodd,3 Michael P Marks,1 Huy M Do1

►► Additional material is ABSTRACT performed with and without intermediate cathe-


published online only. To view Background  Neurointerventional surgeries (NIS) ters.2
please visit the journal online
(http://d​ x.​doi.o​ rg/​10.​1136/​benefit from supportive endovascular constructs. Sofia is A variety of methods are used to advance inter-
neurintsurg-​2017-​013256). a soft-tipped, flexible, braided single lumen intermediate mediate catheters into the proximal cerebral circu-
catheter designed for NIS. Sofia advancement from the lation. For example, an intermediate catheter may
1
Department of Radiology, cervical to the intracranial circulation without a luminal be advanced over a guidewire or over a microca-
Interventional Neuroradiology theter construct, both of which require equipment
guidewire or microcatheter construct has not been
Division, Stanford University
Hospital, Stanford, California, described. introduction through the intermediate catheter.
USA Objective  To evaluate the efficacy and safety of the Placement of equipment into an intermediate cath-
2
Neurointerventional Surgery, new Sofia Non-wire Advancement techniKE (SNAKE) for eter has greater potential for complications, either
California Pacific Medical advancement of the Sofia into the cerebral circulation. by introducing air into the endovascular construct
Center, San Francisco, California,
USA Methods  Consecutive patients who underwent or thrombus formation within the lumen of the
3
Department of Neurosurgery, NIS using Sofia were identified. Patient information, intermediate catheter, by decreasing luminal dead
Stanford University Hospital, SNAKE use, and patient outcome were determined space.
Stanford, California, USA from electronic medical records. Sofia advancement Here we describe the Sofia Non-wire Advance-
to the cavernous internal carotid artery or the V2/V3 ment techniKE (SNAKE), a new technique by
Correspondence to segment junction of the vertebral artery was the primary which the soft-tipped Sofia intermediate catheter
Dr Jeremy J Heit, Department of
Radiology, Neuroimaging and outcome measure. Secondary outcomes included arterial (MicroVention, Tustin, California, USA) is intro-
Neurointervention, Stanford vasospasm and arterial dissection. duced into the intracranial circulation without the
University Hospital, 300 Pasteur Results  263 Patients (181 females, 69%) who assistance of a guidewire or microcatheter construct
Drive, S0047 Stanford, CA underwent a total of 305 NIS using Sofia were identified. within the Sofia lumen. The safety and efficacy of
94305, USA; ​jheit@​stanford.​edu SNAKE is evaluated relative to conventional means
SNAKE (SNAKE+) was used in 187 procedures (61%).
Received 12 June 2017 Two hundred and ninety-three procedures (96%) were of advancing the Sofia over a guidewire or microca-
Revised 3 July 2017 technically successful, which included 184 SNAKE+ NIS theter construct.
Accepted 6 July 2017 and 109 SNAKE− NIS. Primary outcome was achieved
in all SNAKE+ procedures, but not in five SNAKE− Materials and methods
procedures (2%). No arterial dissections were identified Patient identification and inclusion
among 305 interventions. In the intracranial circulation, Our hospital’s Institutional review board approved
a single SNAKE+ patient (0.5%) had non-flow limiting this study, which complied with the Health Insur-
arterial vasospasm involving the petrous internal carotid. ance Portability and Accountability Act. We retro-
Three SNAKE+ patients (1.6%) and one SNAKE− patient spectively identified all patients who underwent a
(0.8%) demonstrated external carotid artery branch NIS using the 5-French Sofia or 6-French Sofia Plus
artery vasospasm during dural arteriovenous fistula or intermediate catheter (MicroVention, Tustin, Cali-
facial arteriovenous malformation treatment. fornia, USA) between January 1, 2014 and April 1,
Conclusion  SNAKE is a safe and effective technique for 2017 at our neurovascular referral center from a
Sofia advancement. Sofia is a highly effective and safe prospectively collected neurointerventional data-
intermediate catheter for a variety of NIS. base. Patient data were obtained from the electronic
medical record.

Introduction Procedural technique


Neurointerventional surgeries (NIS) treat a wide All procedures were performed using a Siemens
range of cerebrovascular pathology that includes Artis Zee biplane system in a dedicated neuroan-
cerebral aneurysms, arteriovenous malformations, giography suite. Procedures were performed under
dural arteriovenous fistulae, ischemic stroke, and monitored anesthesia care or general anesthesia.
To cite: Heit JJ, Wong JHY, intracranial atherosclerotic disease among other Neurophysiologic monitoring was used for all
Mofaff AM, et al.
pathologies. Intermediate catheters provide addi- procedures except for tumor embolizations and
J NeuroIntervent Surg
Published Online First: [please tional support to endovascular constructs to facil- stroke interventions.
include Day Month Year]. itate NIS.1–5 While some have found that interme- Neurointerventional procedures were
doi:10.1136/ diate catheters increase the safety of NIS,3 others performed after catheterizing the common
neurintsurg-2017-013256 have found similar complication rates between NIS femoral artery with a 6-French shuttle SL sheath
Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256    1
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(Cook Medical, Bloomington, Indiana, USA) or an 8-French
Table 1  Sofia SNAKE and complications
Brite Tip sheath (Cordis, Milpitas, California, USA). Intrave-
nous heparin was administered to achieve an activated clotting All SNAKE (−) SNAKE (+)
time of 250–300 s after arterial access was obtained. Cerebral Total procedures 305 (100%) 119 (39%) 187 (61%)
digital subtraction angiography (DSA) was performed with a Total patients 263 (100%) 105 (40%) 158 (60%)
5-French Berenstein II catheter (Cook Medical, Bloomington, Female 181 (69%) 111 (61%) 70 (39%)
Indiana, USA) positioned in the common carotid artery, Age
internal carotid artery (ICA) or the vertebral artery. The  Average age (years) 59 57 61*
Berenstein catheter was then replaced with a 5- or 6-French  Age range (years) 47–74 46–73 51–76
Sofia catheter, which was advanced into the supraclinoid ICA, Pathology treated
M1 segment of the middle cerebral artery, V4 segment of the  Ischemic stroke 80 (26%) 30 (38%) 50 (62%)
vertebral artery, or basilar artery for the subsequent NIS. All
 Cerebral aneurysm 92 (30%) 49 (53%) 43 (47%)
sheaths, Berenstein catheters, Sofia catheters, and microcath-
 Cerebral vasospasm 30 (10%) 7 (23%) 23 (77%)
eters were connected to a continuous heparinized saline flush
 Cerebral AVM 44 (14%) 9 (20%) 35 (80%)
with a Tuohy Borst adapator.
 Facial AVM 7 (2%) 1 (14%) 6 (86%)
 Dural arteriovenous fistula 29 (10%) 14 (48%) 15 (52%)
Sofia Non-wire Advancement techniKE (SNAKE)  Carotid-cavernous fistula 6 (2%) 1 (17%) 5 (83%)
There are four neurointerventionalists in our practice, which  Intracranial atherosclerotic
includes two physicians who used SNAKE in every procedure disease 10 (3%) 3 (30%) 7 (70%)
during the time period evaluation and two physicians who did  Tumor 6 (2%) 3 (50%) 3 (50%)
not use SNAKE. The distal end of the Sofia catheter is extremely  Operative internal carotid
soft and pliable, which led us to test whether the Sofia could be artery injury 1 (0.3%) 1 (100%) 0 (0%)
safely advanced into the cerebral circulation without a guiding *p=0.1, Student’s t test.
wire, microcatheter, or microcatheter and microwire construct AVM, arteriovenous malformation.
within it (SNAKE). SNAKE was performed by introducing the
5-French Sofia or 6-French Sofia Plus into the shuttle sheath Results
positioned in the distal common carotid artery, proximal Two hundred and sixty-three patients (181 females, 69%) who
cervical ICA, subclavian artery, or V1 segment of the verte- underwent a total of 305 interventions using the Sofia catheter
bral artery. Under continuous roadmap guidance, the Sofia was were identified within the study period. Mean patient age was
then advanced through the shuttle into the ICA or vertebral 59 years (IQR 47–74). Cerebral aneurysm embolization (92
artery with no additional equipment within the Sofia lumen. procedures, 30%), acute stroke intervention (80 procedures,
Sofia advancement using SNAKE was stopped when moderate 26%), and cerebral arteriovenous malformation embolization
buckling of the Sofia was observed or any significant resistance (44 procedures, 14%) were the most commonly performed
was felt by the neurointerventionalist. If more distal naviga- interventions (table 1). The 5-French Sofia was used for the
tion of the Sofia was necessary, the SNAKE was terminated majority of procedures (219 procedures, 72%) compared with
and a microcatheter and microwire were then introduced into the 6-French Sofia (86 procedures, 28%) (table 1). However,
the Sofia and advanced more distally. The Sofia was then navi- the 6-French Sofia (69 procedures, 75%) was more commonly
gated over the microwire and microcatheter to the desired used for cerebral aneurysm treatment, which was frequently
position in the intracranial circulation. performed using a balloon microcatheter (30 procedures; 33%)
or stent (12 procedures, 13%) assistance.
Imaging and outcome analysis SNAKE was used in 186 procedures (SNAKE+ group), which
All DSA images from NIS in the study were reviewed by two included 148 procedures with the 5-French Sofia (79%) and 38
neurointerventional radiologists with 4 and 20 years of experi- procedures with the 6-French Sofia Plus (20%). By contrast,
ence. The primary outcome measure was defined as successful conventional Sofia advancement with a guidewire or microcath-
advancement of Sofia to at least the posterior genu of the eter construct (SNAKE− group) was used in 119 patients, which
cavernous ICA in the anterior circulation or to at least the V2/ included 71 procedures with the 5-French Sofia (60%) and 48
V3 segment junction of the vertebral artery in the posterior procedures with the 6-French Sofia Plus (40%). Ischemic stroke
circulation. The secondary outcome measure was complica- treatment (50 procedures), cerebral aneurysm embolization (43
tions that included angiographic evidence of arterial dissection procedures), and cerebral AVM embolization (35 procedures)
or vasospasm following Sofia introduction. The procedure were the most commonly performed NIS that used SNAKE
reports for all studies were reviewed for mention of dissection (table 1). The slight differences in NIS performed between the
or vasospasm. The reports were also reviewed for the use of SNAKE+ and SNAKE− groups reflected variations in physi-
intraprocedural nitroglycerin, which was considered a proxy cian practice pattern rather than a preference for SNAKE when
for non-imaged vasospasm. treating certain types of pathology.
Two hundred and ninety-three procedures (96%) in this study
were technically successful, which included 109 procedures in
Statistical analysis the SNAKE− group (92%) and 184 procedures in the SNAKE+
Statistical analysis was performed using XLSTAT (Addinsoft, group (98%). In the anterior circulation, SNAKE was used to
New York, USA). Χ2 Analysis was used for discontinuous advance the Sofia to at least the posterior genu of the cavernous
variables, and Student’s t test for continuous variables. The ICA (figures 1 and 2 and online supplementary videos 1 and
expected procedural success rate was 95% for the effective- 2) and as distal as the M1 segment of the ICA in all NIS. In
ness analysis. A p value of 0.05 was considered statistically the posterior circulation, SNAKE advanced the Sofia to at least
significant. the distal V2 segment of the vertebral artery and as distal as the
2 Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256
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Figure 1  Elderly patient with an acute ischemic stroke due to occlusion of the M1 segment of the left middle cerebral artery (MCA). (A) Diffusion-
weighted imaging shows a small acute infarction in the left caudate and lentiform nucleus (arrow). (B) Axial maximum intensity projection
image from MR angiography shows occlusion of the M1 segment of the left MCA (arrow). (C) Perfusion-weighted imaging identifies a large
penumbra (arrow) on the time-to-maximum maps. (D) Lateral roadmap image following injection of the left common carotid artery demonstrates
multiple acute turns within the left internal carotid artery (ICA; dashed arrows). This vessel was traversed with a 5-French Sofia using SNAKE (see
online supplementary video 1). (E) Anteroposterior view after left ICA injection demonstrates occlusion of the M1 segment of the left MCA (arrow). (F)
Complete reperfusion of the left MCA (arrow) is present after combined suction and mechanical thrombectomy.

basilar artery (figure 3 and online supplementary video 3) in all Discussion


NIS. SNAKE was used to advance Sofia through 360 degree loops Cerebrovascular diseases, such as aneurysms, AVMs, ischemic
in the cervical common carotid artery and ICA without diffi- stroke, and dural arteriovenous fistulae, are increasingly treated
culty (online  supplementary video 2). In the SNAKE−  group, by endovascular approaches.6 The technological advancements
Sofia could not be advanced to at least the posterior genu of the in guide catheters, intermediate catheters, microcatheters, and
cavernous ICA in four patients and to the V2/V3 junction in one other neurointerventional equipment contribute to the ability
patient owing to excessive vascular tortuosity. A stable endovas- to treat these complex lesions. Intermediate catheters have
cular construct that could safely facilitate embolization could not emerged as an important technological advance that facilitate
be established in these five SNAKE− procedures, which  were more efficient treatment of cerebrovascular disease.2 They
all  aborted. Four procedures in the SNAKE− group and three provide flexibility to the neurointeventionalist, who can adapt
in the SNAKE+ group were aborted owing to unfavorable the stability, support, and length of the endovascular construct
anatomy for endovascular aneurysm embolization or lack of a to his or her needs.1–3 In addition, intermediate catheters may
suitable embolization target. Although SNAKE was more likely reduce procedure time and likely reduce the risk of arterial
to be associated with procedural success (p=0.02), this differ- dissection given the ability to re-access the cerebral circu-
ence most likely reflects patient anatomic differences rather than lation by traversing fewer vascular segments multiple times
the use of this technique. and improving the stability of support of the endovascular
Complications related to Sofia and SNAKE use were construct.3 Despite these purported advantages of intermediate
extremely uncommon. No arterial dissections were identified catheters, NIS complication rates are similar to historical proce-
among 305 interventions. Non-flow limiting arterial vaso- dures without intermediate catheters.2
spasm involving the petrous ICA secondary to a 6-French Sofia The Sofia (Soft torqueable catheter Optimized For Intracranial
was identified in a single SNAKE+ patient, and no other Sofia Access; MicroVention, Tustin, California, USA) is an interme-
related vasospasm instances were identified in the anterior or diate catheter approved for intracranial use. It has an extremely
posterior circulations in either group (table 2). One SNAKE− soft distal tip and has been shown to be an effective tool for isch-
patient and three SNAKE+ patients demonstrated external emic stroke treatment and stent-assisted aneurysm coiling,4 7–10
carotid artery branch artery vasospasm after placement of although its effectiveness for other NIS has not been reported.
a 5-French Sofia for treatment of dural arteriovenous fistula Early in our experience with Sofia, we discovered that Sofia’s
or facial arteriovenous malformations. None of the instances soft distal tip allowed this intermediate catheter to be advanced
of vasospasm was symptomatic, procedurally significant, or into the intracranial circulation without a guidewire, microcath-
clinically significant. There was no significant difference in the eter, or other luminal device (SNAKE). In this study, we describe
complication rate between the SNAKE− and SNAKE+ groups SNAKE as an effective and safe technique for Sofia advancement
(p=0.5). during NIS. In addition, this study is the largest series to evaluate
Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256 3
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New devices
A third advantage of SNAKE is a possible reduction in the
number of times equipment is introduced into the Sofia. Guide-
wire and microcatheter placement within an intermediate cath-
eter introduces the possibility of air entering the closed system.
Furthermore, equipment placement within an intermediate cath-
eter increases the likelihood of thrombus formation within the
construct due to increased foreign material surface area that may
contact blood, blood stasis within the intermediate catheter due
to interruption of heparinized saline flush, and reduced luminal
dead space. Although SNAKE does not reduce these variables
throughout the duration of the procedure, it does minimize the
risk of one step of the procedure, which may increase the safety
of the procedure.
Lastly, our results raise the possibility of reduced equipment
costs in NIS if the need for guidewires, microcatheters, and/or
microwires can be eliminated. Although most procedures will
still require these pieces of equipment, one can imagine how a
stroke intervention performed using an aspiration thrombec-
tomy approach might not require this equipment if Sofia can be
advanced to the thrombus interface using SNAKE.
Sofia was a highly effective as an intermediate catheter in
our study, and 96% of the 305 NIS were technically successful.
Figure 2  Elderly patient with subarachnoid hemorrhage due to Sofia performed well in both the SNAKE− and SNAKE+
rupture of a recurrent left posterior communicating artery aneurysm groups, and the minor differences in procedural success
after prior coil embolization. The aneurysm was re-treated by balloon- between these groups reflected patient anatomic variations
assisted coiling. (A) Non-contrast head CT shows diffuse subarachnoid rather than technical differences in the procedure. Sofia was
hemorrhage (SAH) throughout the basal cisterns (arrow). (B) successfully navigated through significant vascular tortuosity
Roadmap image following injection of the left common carotid artery and into the desired position in the intracranial circulation in
demonstrates a 360 degree loop in the proximal common carotid all but five procedures. It is difficult to compare the effec-
artery (arrow). This vessel was traversed with a 6-French Sofia Plus tiveness of Sofia with prior studies of intermediate catheters
using SNAKE (see online supplementary video 2). (C) Lateral DSA because technical success was either not described or was
image following injection of the cervical left internal carotid artery described for stroke interventions only.1–4 8 9 11 12 However,
demonstrates a broad-based posterior communicating artery aneurysm we have found that Sofia’s trackability into the intracranial
(arrow) that is the cause of the patient’s SAH. (D) The posterior circulation is excellent, and the technical success of this study
communicating artery aneurysm no longer fills following balloon- compares favorably with prior studies of Sofia for stroke inter-
assisted coil embolization (arrow). vention.4 12
Both Sofia and SNAKE had an excellent safety profile, and
no instances of arterial dissection, flow limiting vasospasm, or
the technical success and complication rates related to the Sofia other complications were seen in our study. This safety profile
intermediate catheter across a variety of NIS. is superior to older generation intermediate catheters.2 The
SNAKE was rapid and highly effective in introducing both the external carotid artery braches were more prone to vasospasm
5-French and 6-French Sofia into the intracranial circulation. than the vasculature of the anterior and posterior circulations
The Sofia was advanced to the posterior genu of the cavernous (four patients versus one patient), which likely reflects the
ICA or the V3 segment of the vertebral artery without any resis- anecdotal propensity of the external carotid artery branches
tance or difficulty in all cases. In one stroke intervention, the for vasospasm during angiography.
Sofia was advanced using SNAKE to a clot interface in the M1 Sofia intermediate catheters have a couple of disadvantages.
segment of the middle cerebral artery, which facilitated rapid First, although the softness of the distal tip allows for SNAKE, it
revascularization in this patient. is less supportive than stiffer intermediate catheters. This slight
The main advantage of SNAKE is more rapid access to the decrease in support results in a need for more frequent relax-
intracranial circulation without having to introduce a guidewire ation and addition of tension in the endovascular construct.
or microcatheter construct. Routinely in our practice, one oper- While the authors of this study have become accustomed to
ator advances the Sofia into the intracranial circulation using interacting more with Sofia relative to other intermediate cath-
SNAKE, while a second operator prepares the microcatheter and eters to adjust for this difference, others may find this property
microwire for the planned NIS on the back table. Thus, SNAKE is a limitation in their practice. Next, the slightly larger outer
allows the procedure to proceed efficiently, which provides diameter of the 6-French Sofia (0.0825 in) may lead to incom-
benefit to all NIS in the reduction of in-dwelling catheter times patibility with some endovascular constructs, particularly those
and in particular, for stroke interventions. We did not compare used for ischemic stroke treatment. We routinely placed the
procedure times between the SNAKE− and SNAKE+ groups 6-French Sofia (Sofia Plus) through a 6-French shuttle sheath
because our non-randomized study design, but a future study (Cook Medical) without difficulty, but neurointerventionalists
might assess time as an outcome measure. should note equipment sizes to ensure endovascular construct
A second potential advantage of SNAKE is a reduction in the compatibility with the larger Sofia Plus. We expect that future
distance of intracranial artery that must be traversed by a micro- generations of the Sofia may deal with these shortcomings.
catheter and microwire, which may reduce the risk of arterial The study has several limitations. First, this is a non-ran-
dissection and vasospasm. domized study for comparison of the SNAKE− and SNAKE+
4 Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256
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Figure 3  Young patient with an acute ischemic stroke due to occlusion of the mid-basilar artery. (A) Diffusion-weighted imaging shows acute
infarction in the left pons (arrow). (B) Axial maximum intensity projection image from MR angiography (MRA) shows minimal flow-related signal
within the basilar artery (arrow). (C) Reconstructed MRA image in the lateral project demonstrates occlusion of the mid-basilar artery (arrow). The
patient has widely patient posterior communicating arteries (arrowhead) that supply the posterior cerebral arteries (dashed arrow). (D) Lateral
roadmap image following injection of the left vertebral artery demonstrates multiple acute turns within this vessel (dashed arrows). This vessel was
traversed with a 5-French Sofia using SNAKE (see online supplementary video 3). (E) Lateral view after left vertebral artery injection demonstrates
occlusion of the mid-basilar artery (arrow). (F) Complete reperfusion of the basilar artery (arrow) is present after combined suction and mechanical
thrombectomy.

groups, which might have introduced operator bias. This Conclusions


study design introduces the possibility of other variables that The Sofia Non-wire Advancement techniKE (SNAKE) is a safe
influence the technical success and safety outcome measures. and effective technique for Sofia advancement into the intracra-
Additionally, the size of our cohorts, self-reported results, nial circulation. Sofia is a highly effective and safe intermediate
and inclusion of patients from a single neurovascular referral catheter during a variety of NIS.
center might have biased our results. These shortcomings
could be overcome through a larger, randomized trial. Lastly, Contributors  All authors made substantial contributions to the conception and
design of the study, acquisition of data, or analysis and interpretation of data.
we describe SNAKE as a technique for advancement of the
Sofia intermediate catheter. We have not applied this tech- Funding  This research received no specific grant from any funding agency in the
public, commercial or not-for-profit sectors.
nique routinely to other intermediate catheters, but such a
Competing interests  JJH and HMD are consultants for MicroVention, Inc.
study could certainly be performed. We would advocate that
the application of SNAKE to other catheters be undertaken Ethics approval  Institutional review board.
with caution as intermediate catheters have varying degrees of Provenance and peer review  Not commissioned; externally peer reviewed.
softness, which may affect the risk of vessel dissection during Data sharing statement  Published and unpublished data may be shared for
non-wire advancement. additional publications pending the authors’ agreement to a research collaboration
when appropriate.

Table 2  Complications due to sofia and SNAKE © Article author(s) (or their employer(s) unless otherwise stated in the text of the
article) 2017. All rights reserved. No commercial use is permitted unless otherwise
Complica- Sofia Sofia expressly granted.
tions Sofia (All) (5-Fr) (6-Fr) SNAKE (−) SNAKE (+)
Vessel
dissection 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) References
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Vertebral two center experience and a proposed taxonomy. J Neurointerv Surg 2014;6:618–23.
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Neuroradiol 2016;26:325–8.
External
4 Wong JHY, Do HM, Telischak NA, et al. Initial experience with SOFIA as an
carotid
intermediate catheter in mechanical thrombectomy for acute ischemic stroke. J
vasospasm 4 (1%) 4 (1.8%) 0 (0%) 1 (0.8%) 3 (1.6%)
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Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256 5


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6 Heit JJ, et al. J NeuroIntervent Surg 2017;0:1–6. doi:10.1136/neurintsurg-2017-013256


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Sofia intermediate catheter and the SNAKE


technique: safety and efficacy of the Sofia
catheter without guidewire or microcatheter
construct
Jeremy J Heit, Johnny HY Wong, Adrienne M Mofaff, Nicholas A
Telischak, Robert L Dodd, Michael P Marks and Huy M Do

J NeuroIntervent Surg published online August 2, 2017

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