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
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 SCENT Trial The Surpass intracranial aneurysm EmbolizatioN system pivotal Trial to treat large or giant wide neck aneurysms
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) 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) 32 12 Cobalt chromium alloy 92% platinum, 8% tungsten 20-32 3.9/3.7 0.057 135 *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 increase in device diameter Result = Consistent Mesh Density across a range of vessel sizes +24* * pores/mm 2 +24* +24*
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 Increasing wire count from 48 to 72 Reduces aneurysm inflow rate by 24% Shrinks the impact zone by almost 90% Images courtesy of Gainluca De Santis and Matthieu De Beule, FEOps 48 Wire Braid 72 Wire Braid (Surpass ) 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%
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.
Surpass Delivery System Designed for consistent deployment while allowing the physician to maintain wire access
Streamlined Halo Delivery System 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
Streamlined Streamline Delivery System Flexible Delivery 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
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
SCENT Trial * Site reported data as of 5/29/2014 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% 4 or greater 0.0%
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 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% Supraclinoid Carotid Artery 20.0% Carotid Cavernous Artery 1.3% 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.
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