Surpass™ Flow Diverter Specifications 2 3 4 5

Maximum vessel diameter 2.5mm 3.5mm 4.4mm 5.3mm

Recommended minimum 2.0mm 2.5mm 3.4mm 4.3mm

Number of total wires 48 72 72 96

Wire diameter 25µm 32µm

Number of marker wires 12

Braided wire material Cobalt chromium alloy

Marker wire material 92% platinum 8% tungsten

Mesh density (pores/mm2) 20–32

Delivery System 2 3 4 5

Outer Diameter, proximal/distal 3.7F / 3.3F(1.2mm / 1.1mm)

3.9F / 3.7F (1.3mm / 1.2mm)

Minimum recommended microcatheter ID 0.057in (1.447mm)

Working length 150cm 135cm

Copyright © 2013 Stryker90816304.AE

Product Sizes and Catalog Numbers

Longer sizes, as compared to competitive products, may reduce the number of devices needed per aneurysm

Selection GuideSurpass™ Flow Diverter

See package insert for complete indications, contraindications, warnings and instructions for use

DEVICE DESCRIPTIONThe Surpass Flow Diverter System is comprised of a self-expandable braided device preloaded in a Delivery Catheter.The Surpass Flow Diverter System consists of the following components:• Surpass Flow Diverter• Surpass Delivery Catheter• PusherThe Surpass Flow Diverter is preloaded onto the Pusher which in turn is locked in place within the Delivery Catheter via a Y-Valve/Rotating Hemostatic Valve (RHV). Each device is shipped sterile and labeled for single use only.

INTENDED USE/INDICATIONS FOR USE The Surpass Flow Diverter is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter of ≥2 mm and ≤5.3 mm.

CONTRAINDICATIONS Intracranial artery stenting is generally contraindicated in the following patient types: • Patients in whom the parent vessel size does not fall

within the indicated range.• Patients in whom antiplatelet and / or

anticoagulation therapy (aspirin and clopidogrel) is contraindicated.

• Patients who have not received dual anti-platelet agents prior to the procedure.

• Patients with an active bacterial infection.• Patients in whom the angiography demonstrates

the anatomy is not appropriate for endovascular treatment, due to conditions such as:

– Severe intracranial vessel tortuosity or stenoses – Intracranial vasospasm not responsive to medical therapy

WARNINGS• The procedure should be carried out under the

direction of personnel with the requisite interventional training, especially intracranial stent procedures. Appropriate facilities should be available for managing the potential complications of the procedure.

• Complications may occur without warning. At all times a fully equipped emergency cart and resuscitation equipment should be readily available, and personnel competent in recognizing and treating complications of any severity should be on hand.

• Do not use if the inner package is opened or damaged.

• The system is designed to be manipulated while under high-quality fluoroscopic observation. If resistance is met during manipulation, determine the cause of resistance before proceeding.

• Do not torque or rotate the System.• Purge the entire Surpass Delivery System carefully to

avoid the accidental introduction of air into the system.• Ensure optimal positioning of the Surpass Flow

Diverter prior to deployment. Once deployment is initiated, the Surpass Flow Diverter cannot be resheathed or recaptured.

PRECAUTIONS• Experience with device implants indicates that there

is a risk of stenosis. Subsequent stenosis may require dilatation of the vessel segment containing the device. The risks and long-term outcome following dilatation of endothelialized devices is unknown at present.

• Confirm the device labeling reflects the desired size of the target vessel where the device is to be used.

• Do not expose the system to organic solvents (e.g., alcohol).

• Appropriate anti-platelet and anti-coagulation therapy should be employed in accordance with standard medical practice.

• A thrombosing aneurysm may aggravate pre-existing or cause new symptoms of mass effect and may require medical therapy.

• Use product prior to the “Use By” date.• The ability of the device to withstand balloon post-

dilatation has not been established.• Do not remove the Surpass Flow Diverter from its

Delivery Catheter. The device and delivery catheter are intended to perform as a single system and must not be altered.

• Carefully inspect the device packaging and system prior to use. Do not use the Surpass Flow Diverter if any component appears damaged or missing.

• Do not pull up on the Pusher when removing the Surpass Delivery System from its tray. Instead hold the Delivery System by its RHV and hoop to facilitate removal from the tray.

• Select a device length that is at least 10 mm longer than the aneurysm neck to maintain a minimum of 5 mm on either side of aneurysm neck.

• Do not attempt to move the Surpass Flow Diverter more distally once it has begun to appose the vessel walls.

• Use caution when crossing the deployed device with guidewires or other accessory devices.

• Dispose of all used devices in accordance with hospital policy for biohazardous materials.

ADVERSE EVENTSRisks that may be associated with the use of the Surpass Flow Diverter System in the intracranial arteries include:• Aneurysm recanalization• Aneurysm enlargement• Allergic reaction including, but not limited to,

contrast, cobalt chromium or platinum tungsten metal, and medications

• Arrhythmia• Arteriovenous fistula• Confusion, coma, loss of consciousness or other

change in mental status• Death• Detachment of a component of the system• Emboli (air, tissue or thrombotic emboli)• Emergent neurosurgery• Failure to deliver the device to the intended site• Headache• Hemorrhage (including intracranial, vascular,

peritoneal, and groin)• Hematoma• Hypotension / Hypertension• Hydrocephalous• Incomplete Aneurysm Occlusion• Infection• Injury to normal vessels or tissue• Ischemia• Occlusion of side branch• Mass effect• Myocardial infarction• Nausea• Neurologic deficit• Pain at insertion site• Perforation of aneurysm• Pseudoaneurysm• Reactions due to radiation exposure• Renal failure• Rupture, vessel or aneurysm• Seizures• Stenosis of treated segment• Device migration / embolization• Device thrombosis / occlusion• Stroke /TIA/ cerebrovascular accident – new or

worsening of symptoms• Total occlusion of treated segment• Vasospasm• Vessel dissection or perforation• Vessel thrombosis/occlusion• Visual impairment/blindess• Vomiting

Class III RAQA ManagerStryker France S.A.S.ZAC-Avenue de Satolas Green69330 PusignanFrance

Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515

stryker.com/neurovascularstryker.com/emea/neurovascular

Date of Release: 15/AUG/2013

0344

Diameter (mm)

2 3 4 5

Len

gth

(m

m)

12 502FPP

15 503FPP 100FPP 115FPP

20 504FPP 101FPP 110FPP 124FPP

25 102FPP 111FPP 120FPP

30 112FPP 121FPP

40 113FPP 122FPP

50 114FPP 123FPP

Consistency Matters

Stroke: Our Only Focus. Our Ongoing Promise.

Consistent...OCCLUSIONThe number of braid wires increases with the device diameter, maintaining consistent mesh density for increased efficacy. Maintaining consistent mesh density may lead to faster aneurysm occlusion.

COVERAGELonger device lengths offered across multiple diameters, designed to effectively bridge wide-necked aneurysms and reduce the need for multiple devices.

DEPLOYMENTCustomized over-the-wire delivery system improves device delivery and detachment.

Higher Mesh Density. Consistent Occlusion.

Unique preloaded delivery system. Consistent Deployment.

Schematic showing equal

porosities (50%) but

different mesh densities.

Diagram A has 16 times

higher mesh density than

Diagram B.*

No Surpass Flow Diverter has a mesh density of <20 pores/mm2 even in larger vessel diameters

Mes

h D

EN

SIT

Y (p

ores

/mm

2 )

1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6

ARTERY DIAMETER (mm)

33

30

27

24

21

18

15

12

39

36

Mesh Density Comparison

Product A4.0mm 48w

Product B4.0mm 48w

Surpass™ Flow Diverter

3.0mm 72w

Surpass Flow Diverter

5.0mm 96w

Surpass Flow Diverter

4.0mm 72w

The SurpassTM Flow Diverter comes preloaded onto its own microcatheter.

The pusher is housed in the delivery catheter and pushes the Surpass Flow Diverter

out of the catheter and into the parent artery. The pusher stabilizes the position of

the Surpass Flow Diverter in the delivery catheter.

*Stroke October 1, 2010 vol. 41 no. 10 suppl 1 S21-S25Bench test results may not necessarily be indicative of clinical performance. Testing completed by Stryker Neurovascular. Data on file and available upon request.Results from case studies are not predictive of results in other cases. Results in other cases may vary.

PUSHER Y-VALVE DELIVERY CATHETER SEE DETAIL A

PUSHER TIP MARKER

DETAIL A

PROXIMAL PUSHER MARKER

FLOW DIVERTER

DELIVERY CATHETER

10mm

DISTAL TIP OF DELIVERY MARKER

Images courtesy of Matthew J. Gounis, PhD. Associate Professor, Director: New England Centre for Stroke Research, University of Massachusetts, USA

Images courtesy of Dr. Joost de Vries, Department of Neurosurgery, Radboud University Nijmegen, The Netherlands

left supra-ophthalmic segment of the internal carotid artery

PRE-PROCEDURE

3-D angiogram shows diseased left ICA prior to placement of a Surpass Flow Diverter

6 MONTH FOLLOW-UP

Angiogram showing:

• Complete remodeling of the ICA and obliteration of aneurysms

• Patency of ophthalmic and posterior cerebral arteries that were covered with 4x20mm Surpass Flow Diverter

Radiography shows excellent visibility of 12 braided platinum markers. SurpassTM Flow Diverter 4x20mm

SIDE BRANCH PATENCY

FIGURE 1

A Scanning electron microscopy (SEM) image of a rabbit abdominal aorta implanted with a Surpass Flow Diverter

B Magnified view (40x) at 6 months showing multiple struts which do not compromise the patency of the renal artery

FIGURE 2

A backscatter EM image of a rabbit aorta at 6 months. This shows smooth and complete endothelial coverage of the Surpass Flow Diverter and highlights the patency of a very small artery (154x)

A B

A B