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