SURPASS™ FLOW DIVERTER
SCENT TRIAL UPDATE
Ajay K. Wakhloo, M.D., Ph.D., FAHA
Department of Radiology, Neurology and
Neurosurgery
Division Neuroimaging and Intervention
University of Massachusetts
SVIN - Hollywood, FL
November 7-9, 2014
SCENT Trial
The Surpass
intraCranial
aneurysm
EmbolizatioN
system pivotal
Trial to treat large
or giant wide neck
aneurysms
23 Participating and Enrolling Centers
• Mayo Clinic, Rochester, MN
• Mayo Clinic, Jacksonville, FL
• Oregon Health and Science University, OR
• University of Florida, Gainesville, FL
• Rush University Medical Center, IL
• Johns Hopkins, Baltimore, MD
• Thomas Jefferson University, Philadelphia, PA
• UT Southwestern, TX
• University of Utah, Salt Lake City, UT
• Vanderbilt University Medical Center, Nashville, TN
• Columbia, New York, NY
• Medical University of South Carolina, Charleston, SC
• University of Nijmegen, Nijmegen, The Netherlands
• Tampa General Hospital, Tampa, FL
• University of Massachusetts Medical School, Worcester, MA
• Lyerly Clinic, Jacksonville, FL
• Cleveland Clinic Foundation, Cleveland, OH
• University of Virginia, Charlotte, VA
• Fort Sanders Regional Medical Center, Knoxville, TN
• Baptist Cardiovascular Institute, Miami, FL
• Froedtert Medical Center, Milwaukee, MI
• University of New York at Buffalo, Buffalo, NY
• University of Stanford, Stanford, CA
1
Surpass™ FD Product Characteristics*
*In the US, the Surpass FD is an investigational device limited by federal law to
investigational use
Surpass™ Flow Diverter Specifications 3mm 4mm 5mm
Maximum vessel diameter (mm) 3.5 4.4 5.3
Recommended minimum (mm) 2.5 3.4 4.3
Number of total wires 72 72 96
Wire diameter (µm)
Number of marker wires
Braided wire material
Marker wire material
Mesh density (pores/mm3)
Delivery System 3mm 4mm 5mm
French size (proximal/distal)
Minimum recommended microcatheter ID (in)
Working length (cm)
0.057
135
32
12
Cobalt chromium alloy
92% platinum, 8% tungsten
20-32
3.9/3.7
Flow Diversion
Consistent Mesh Density = Consistent Occlusion
With the Surpass™ Flow Diverter, the number of braid wires increases with an increase in device diameter
Result = Consistent Mesh Density across a range of vessel sizes
+24* +24*
* pores/mm2
+24*
Why is Mesh Density important?
Flow Diversion
Consistent flow diversion across vessels that taper
Blue arrow Red arrow
Why is Mesh Density important?
Flow Diversion
Images courtesy of Gainluca De Santis and Matthieu De Beule, FEOps
Mesh density and braid angle affect fluid velocity
Increasing wire count from 48 to 72
– Reduces aneurysm inflow rate by 24%
– Shrinks the impact zone by almost 90%
Inflow Rate (mL/S) Aneurysmal Inflow Turnover Time Impact Zone (mm2 / %)
Before Stenting 2.241 42% 0.099s 137 / 74%
48 wires 33 microns 1.302 25% 0.171s 92 / 50%
72 wires 32 microns 0.991 19% 0.217s 10 / 6%
96 wires 32 microns 0.779 15% 0.277s 10 / 6%
48 Wire Braid
72 Wire Braid
(Surpass™)
Surpass™ Device
Images courtesy of Dr. J Mocco,
Vanderbilt University Med. Ctr. Nashville, TN Images courtesy of Dr. P. Kan,
Tampa General Hosp. Tampa, FL
Images courtesy of Dr. K. Lui,
UVA. Charlottesville, VA
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Designed to Open Consistently
More wires for a stable braid
Cobalt Chromium for a stronger braid
Radial force has been optimized
Continuous opening with no kinking or twisting
OTW System
Independent control of guidewire tip during deployment
Maintain guidewire access
Long length devices
Designed for consistent deployment while allowing the
physician to maintain wire access
Surpass™ Delivery System
Streamlined
Delivery Improved Access in Tortuous Anatomy
• Atraumatic access to distal vasculature using an intermediate catheter
• Improved fit with better climbing performance
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Images courtesy of Dr. Alex Coon, Johns Hopkins Univ. Baltimore, MD
Halo™ Delivery System
Streamlined
Delivery Flexible
• Nitinol reinforced outer catheter • Triple wind proximal to single wind distal
• Multiple polymer segments in distal end to lower track force
Stable
• Reinforced hypotube for increased column strength • Polyimide braided shaft technology
• Continuous stainless steel braid reinforcement from hypotube to pusher tip
Streamline™ Delivery System
Recapture and Redeploy
Designed for precise placement
Designed to enhance vessel apposition
Engineered to be repositioned up to 3x
Note: Device can be recaptured as long as there is a minimum 11mm gap between catheter tip marker and proximal pusher marker
Streamline™ Delivery System
Initial Deployment Post
Streamline™ Delivery System
SCENT Trial
Study Design
• A multi-center, prospective, non-randomized trial to
evaluate the safety and effectiveness of the Surpass™
Flow Diverter compared to a historical control in the
treatment of large or giant wide-neck intracranial
aneurysms.
SCENT Trial Primary Endpoints
• Primary Efficacy Endpoint
The percent of subjects with 100% occlusion (Raymond Class I)
without clinically significant stenosis (defined as ≤ 50% stenosis) of the
parent artery based on core lab evaluation of the 12 month follow-up
angiogram and without any subsequent treatment at the target
aneurysm at the 12-month follow-up visit.
• Primary Safety Endpoint
The percent of subjects experiencing neurologic death or major
ipsilateral stroke through 12 months.
SCENT Trial Inclusion Criteria
• Age 19 to 80 years
• Subject or legal representative willing/able to give informed consent
• Subject has single targeted intracranial aneurysm:
Located in ICA up to terminus
Able to be crossed with standard 0.014” guidewire
Neck >4 mm (or no discernible neck) and aneurysm size >10
mm (including fusiform, saccular, dissecting)
Parent vessel diameter 2.5 mm - 5.3 mm at both proximal and
distal segments
• Subject agrees to return for all scheduled f/u visits
SCENT Trial
Follow-Up
• 1, 6, 12 months post-procedure f/u
• 24, 36, 48, 60 months post-market f/u
Sample-Size
• Protocol allows for up to 45 roll-in subjects
• Minimum/Maximum = 100/180 evaluable subjects
• Adaptive design
Final sample-size calculated based on 6-month data
for first 40 subjects treated
SCENT Trial Demographic Data* Parameter Value
Mean ± SD 62.8 +/- 9.7
Median (Min, Max) 64.0 (38.0, 79.0)
Male 9.9%
Female 90.1%
American Indian/Alaskan Native 0.0%
Asian 4.9%
Black or African American 14.8%
Native Hawaiian/Pacific Islander 0.0%
White 76.5%
Other 1.2%
Not Reported 3.7%
Mean ± SD 65.0 +/- 3.2
Median (Min, Max) 65.0 (57.9, 72.0)
Mean ± SD 161.2 +/- 41.9
Median (Min, Max) 151.8 (83.6, 275.0)
0 70.4%
1 13.6%
2 11.1%
3 4.9%
4 or greater 0.0%
Age (yrs)
Sex
Race
Height (in)
Weight (lbs)
mRS
* Site reported data as of 5/29/2014
SCENT Trial Aneurysm Characteristics*
* Core Lab reported data as of 5/29/2014
+ Aneurysms may be more than one type
++ Aneurysms may cover more than one location
Parameter Value
Mean ± SD 12.9 +/- 5.5
Median (Min, Max) 11.1 (3.4, 27.5)
Mean ± SD 14.3 +/- 5.4
Median (Min, Max) 13.2 (5.9, 27.3)
Mean ± SD 13.5 +/- 5.5
Median (Min, Max) 12.8 (4.3, 27.4)
Mean ± SD 6.1 +/- 2.5
Median (Min, Max) 5.2 (3.3, 14.5)
Saccular 90.7%
Fusiform 9.3%
Segmental 1.3%
Dysplastic 1.3%
Petrous Segment 13.3%
Cavernous Segment 29.3%
Carotid-Ophthalmic 20.0%
Posterior Communicating Artery 16.0%
Supraclinoid Carotid Artery 20.0%
Carotid Cavernous Artery 1.3%
Superior Hypophyseal Artery 6.7%
Dome Height (mm)
Dome Width (mm)
Dome Depth - If Not Spherical (mm)
Neck Width (mm)
Aneurysm Type+
Aneurysm Location++
Case 1: Giant Sacular ICA Aneurysm - could have been classified as fusiform as there was no defined path for GW (4x50 implant)
Delivery - easy past neck of aneurysm (stent positioned appropriately in system pre-deployment despite observing some resistance
distal to aneurysm (180 degree + turn)
Deployment - accurately placed, stent opened - but did take MC through implant and employed post dil for mass effect at distal end and
belly of implant (GW balloon used)
Diversion - excellent
Case Learning:
1. Use unsheathe, advance, unsheathe technique if tortuous turn observed just distal to distal neck of aneurysm
2. If mass effect is observed, be prepared to post-dil to ensure full expansion of implant
Initial Deployment Post
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Case 2: Giant Saccular ICA Aneurysm - could have been classified as fusiform as there was no defined path for GW (two 4x50 implants) Delivery - easy for both systems Deployment - both stents were accurately placed and opened well (post dilation used to address mass effect at belly of stent and at proximal end) Diversion - excellent Case Learning: - telescoping may reduce the risk of the first stent prolapsing into fusiform aneurysm (observation of excessive stent expansion is indicator) - post dilation at belly and/or proximal end of stent can increase foreshortening and pull stent away from sticking out in vessel curves/bends
Initial Deployment Post
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Thank You