SURPASS™ FLOW DIVERTER

SCENT TRIAL UPDATE

Ajay K. Wakhloo, M.D., Ph.D., FAHA Department of , and Division Neuroimaging and Intervention University of Massachusetts

SVIN - Hollywood, FL November 7-9, 2014 23 Participating and Enrolling Centers SCENT Trial • Mayo Clinic, Rochester, MN • Mayo Clinic, Jacksonville, FL • Oregon Health and Science University, OR The Surpass • University of Florida, Gainesville, FL • Rush University Medical Center, IL intraCranial • Johns Hopkins, Baltimore, MD • Thomas Jefferson University, Philadelphia, PA • UT Southwestern, TX EmbolizatioN • University of Utah, Salt Lake City, UT • Vanderbilt University Medical Center, Nashville, TN system pivotal • Columbia, New York, NY • Medical University of South Carolina, Charleston, SC Trial to treat large • University of Nijmegen, Nijmegen, The Netherlands or giant wide neck • Tampa General Hospital, Tampa, FL • University of Massachusetts , 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*

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) 32 Number of marker wires 12 Braided wire material Cobalt chromium alloy Marker wire material 92% platinum, 8% tungsten Mesh density (pores/mm3) 20-32 Delivery System 3mm 4mm 5mm French size (proximal/distal) 3.9/3.7 Minimum recommended microcatheter ID (in) 0.057 Working length (cm) 135

*In the US, the Surpass FD is an investigational device limited by federal law to investigational use Flow Diversion

Consistent Mesh Density = Consistent Occlusion

. With the Surpass™ Flow Diverter, the number of braid wires increases with an +24* +24* +24* increase in device diameter . Result = Consistent Mesh Density across a range of vessel sizes

* pores/mm2 Flow Diversion

Why is Mesh Density important? . Consistent flow diversion across vessels that taper

Red arrow Blue arrow Flow Diversion Why is Mesh Density important? . Mesh density and braid angle affect fluid velocity 48 Wire Braid . Increasing wire count from 48 to 72

– Reduces aneurysm 72 Wire inflow rate by 24% Braid

– Shrinks the impact (Surpass™) 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%

Images courtesy of Gainluca De Santis and Matthieu De Beule, FEOps Surpass™ Device

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

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

Images courtesy of Dr. J Mocco, Images courtesy of Dr. P. Kan, Images courtesy of Dr. K. Lui, Vanderbilt University Med. Ctr. Nashville, TN Tampa General Hosp. Tampa, FL UVA. Charlottesville, VA Surpass™ Delivery System

Designed for consistent deployment while allowing the to maintain wire access StreamlinedHalo™ Delivery System ImprovedDelivery 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 StreamlinedStreamline ™ Delivery System Flexible

•DeliveryNitinol 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 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 (defined as ≤ 50% stenosis) of the parent 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 : . 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 Age (yrs) Mean ± SD 62.8 +/- 9.7 Median (Min, Max) 64.0 (38.0, 79.0) Sex Male 9.9% Female 90.1% Race 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% Height (in) Mean ± SD 65.0 +/- 3.2 Median (Min, Max) 65.0 (57.9, 72.0) Weight (lbs) Mean ± SD 161.2 +/- 41.9 Median (Min, Max) 151.8 (83.6, 275.0) mRS 0 70.4% 1 13.6% 2 11.1% 3 4.9% * Site reported data as of 5/29/2014 4 or greater 0.0% SCENT Trial Aneurysm Characteristics* Parameter Value Dome Height (mm) Mean ± SD 12.9 +/- 5.5 Median (Min, Max) 11.1 (3.4, 27.5) Dome Width (mm) Mean ± SD 14.3 +/- 5.4 Median (Min, Max) 13.2 (5.9, 27.3) Dome Depth - If Not Spherical (mm) Mean ± SD 13.5 +/- 5.5 Median (Min, Max) 12.8 (4.3, 27.4) Neck Width (mm) Mean ± SD 6.1 +/- 2.5 Median (Min, Max) 5.2 (3.3, 14.5) Aneurysm Type+ Saccular 90.7% Fusiform 9.3% Segmental 1.3% Dysplastic 1.3% Aneurysm Location++ Petrous Segment 13.3% Cavernous Segment 29.3% Carotid-Ophthalmic 20.0% Posterior Communicating Artery 16.0% * Core Lab reported data as of 5/29/2014 Supraclinoid Carotid Artery 20.0% + Aneurysms may be more than one type Carotid Cavernous Artery 1.3% ++ Aneurysms may cover more than one location Superior Hypophyseal Artery 6.7% Initial Deployment Post

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 Results from case studies are not predictive of results in other cases. Results in other cases may vary. Initial Deployment Post

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 Results from case studies are not predictive of results in other cases. Results in other cases may vary. Thank You