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JETSTREAM Atherectomy System DELIVERING VERSATILITY TO RESTORE FLOW

Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

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Page 1: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

JETSTREAM™ Atherectomy System

DELIVERING VERSATILITYTO RESTORE FLOW

Page 2: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

Versatility means not having to guess the morphology! Peripheral arterial lesions can present with a range of morphologies from soft thrombus to plaque and difficult calcification – often in the same vessel. The Jetstream™ Atherectomy System is indicated for both thrombectomy and atherectomy and has demonstrated its ability to deliver luminal gain in soft, hard and calcified lesions.1,2

DISCOVER THE VALUE OF VERSATILITY

FEATURE BENEFITJetstream Orbital Directional Laser

Complex lesions and total occlusion often contain mixed morphology lesions, requiring a device capable of managing it all.

Aspiration of liberated debris may minimize the risk of distal embolization.

Total occlusions are common in PAD, front cutting enables engagement of tightest lesions.

Concentric lumens facilitate straight line laminar flow.

Differential cutting targets only the plaque, minimizing the risk of vessel damage.

Expandable blades deliver more versatility, facilitating treatment from SFA to TPT.

Peripheral arterial disease rarely manifests as a single lesion type. A mix of disease morphologies is common, driving the need for a single device capable of addressing them all.

Labeling Indication

Lesion Type

Atherectomy

Thrombectomy

Active Aspiration

Total Occlusions

Thrombus

Calcium

Soft Plaque

Fibrous Plaque

Front Cutting / Rotational Device

Concentric Lumens

Differential Cutting

Expandable Blade Technology

Versatility means not having to switch in the middle of a procedure!The Jetstream™ Atherectomy System offers the XC Catheter for above the knee and the SC Catheter for below the knee. In addition, the XC series has expandable blade technology that can deliver two lumen sizes with the same catheter.

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Page 3: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

Images show result from one case, results may vary.

RESTORE FLOW WITH THE MOST VERSATILE ATHERECTOMY SYSTEM AVAILABLE

Prior to treatment, IVUS shows tight, irregular lesion

After treatment with Jetstream™ XC catheter, IVUS shows concentric luminal gain

Treat It All with One Device1 From thrombus to difficult calcium, both above and below the knee.

Dual Indication Both atherectomy and thrombectomy from the same catheter.

CTOs and Tight Stenoses True front-cutting tips follow the guidewire through tight lesions without pre-dilation.

Increase / Remodel Lumen Area Rotational design supports concentric lumens, which facilitate laminar flow.

Remove the Debris The Jetstream™ System is the only atherectomy device with continuous active aspiration.

Page 4: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

AT

KB

TK

EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE

Jetstream™ XC Atherectomy Catheter

Jetstream™ XC Atherectomy Catheter

Jetstream™ SC Atherectomy Catheter

Jetstream™ SC Atherectomy Catheter

1.6 mmCatheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

145cm 7F 0.014” 1.6mm 73K rpm

2.4 mm 3.4 mmCatheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

120cm 7F 0.014” 2.4mm 3.4mm 70K rpm

1.85 mmCatheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

145cm 7F 0.014” 1.85mm 73K rpm

Catheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

135cm 7F 0.014” 2.1mm 3.0mm 70K rpm

2.1 mm 3.0 mm

Page 5: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

The lighter, more ergonomic XC and SC catheters are designed to enhance ease of use. Control buttons are integrated into the mouse, which can be used either in the pod or removed for remote activation. The improved Wire GARD simplifies wire management.

ERGONOMIC, SINGLE OR DUAL-OPERATOR DESIGN

Catheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

120cm 7F 0.014” 2.4mm 3.4mm 70K rpm

Catheter Length Min. Introducer Size Max. Guidewire Diameter Tip Diameter Target Therapy Speed

145cm 7F 0.014” 1.85mm 73K rpm

Control buttons integrated into mouse

Wire GARD activation button on side of POD

Wire GARD integrated into POD

Lighter and more ergonomically designed control POD

Mouse embedded within POD

• Ergonomic design with 32% smaller* POD enhances user experience

• Intuitive user interface facilitates single or dual operator use

• Improved wire GARD* simplifies wire management

• Advanced package and POD design reduces environmental footprint

*As compared to previous, G3 version catheters.

Page 6: Jetstream System Brochure - Boston Scientific · ATK BTK EFFECTIVELY TREAT LESIONS ABOVE AND BELOW THE KNEE Jetstream™ XC Atherectomy Catheter Jetstream™ XC Atherectomy Catheter

Product Description Catalog Number

Jetstream™ SC Atherectomy Catheter 1.85 mm PV3118F

Jetstream™ SC Atherectomy Catheter 1.6 mm PV3116F

Jetstream™ XC Atherectomy Catheter 2.4 mm / 3.4 mm PV41340

Jetstream™ XC Atherectomy Catheter 2.1 mm / 3.0 mm PV31300

Product Description Catalog Number

Jetstream™ JETWIRE PV014300

ordering information

Jetstream™

JETWIRE

CONSOLE

COMPONENTS

1 Zeller T et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62.

2 http://www.eventscribe.com/2013/posters/isetcio/SplitViewer.asp?PID=MTEwNTg2MjU2 “Jetstream Atherectomy System Can Remove Superficial Calcium in Severely Calcified Peripheral Arteries”

Peripheral Interventions300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com

To order product or for more informationcontact customer service at 1.888.272.1001.

© 2015 Boston Scientific Corporationor its affiliates. All rights reserved.

PI-273812-AB OCT2015

JETSTREAM™ CATHETERS COMBINED WITH CONSOLE

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.Catheter INDICATIONS: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature. Console INDICATIONS: The PV Console is designed for use only with the Jetstream Catheter and Control Pod. See the current revision of the applicable Catheter and Control Pod Instructions for Use for further information. CONTRAINDICATIONS: No known contraindications. Catheter WARNINGS/PRECAUTIONS: • The Jetstream Catheter and Control Pod may only be used with the PV Console. • Take care to avoid being pinched when closing the aspiration and infusion pump doors. • Use room temperature infusate only. Use of heated infusate may lead to wrinkling, ballooning and/or bursting of the outer catheter sheath. • Do not bend or kink the Catheter during setup or during the procedure. This may damage the device and lead to device failure. • Operating the Catheter over a kinked guidewire may cause vessel damage or guidewire fracture. • During treatment, do not allow the Catheter tip within 10.0 cm of spring tip portion of the guidewire. Interaction between the Catheter Tip and this portion of the guidewire may cause damage to or detachment of the guidewire tip or complicate guidewire management. • The guidewire must be in place prior to operating the Catheter in the patient. Absence of the guidewire may lead to inability to steer the Catheter and cause potential vessel damage. • Do not inject contrast while the device is activated. • If the guidewire is accidentally retracted into the device during placement or treatment, stop use, and remove the Catheter and the guidewire from the patient. Verify that the guidewire is not damaged before re-inserting the guidewire. If damage is noticed, replace the guidewire. • Check the infusate bag frequently and replace when needed. Do not run the JETSTREAM System without infusate as this may cause device failure. • Hold the guidewire firmly during Catheter retraction process. Failure to do so may result in guidewire rotation within the vessel. • Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined. • Use only listed compatible guidewires and introducers with the Jetstream System. The use of any supplies not listed as compatible may damage or compromise the performance of the Jetstream System. Prior to use of the Jetstream System, confirm the minimum vessel diameter proximal to the lesion per the following: Jetstream SC Atherectomy Catheter 1.6 Minimum Vessel Diameter Proximal to Lesion 2.5 mm; Jetstream SC Atherectomy Catheter 1.85 Minimum Vessel Diameter Proximal to Lesion 2.75 mm; Jetstream XC Atherectomy Catheter2.1-3.0 Minimum Vessel Diameter, Blades Down 3.0 mm; Minimum Vessel Diameter, Blades Up 4.0 mm; Jetstream XC Atherectomy Catheter2.4-3.4 Minimum Vessel Diameter, Blades Down 3.5 mm; Minimum Vessel Diameter, Blades Up 4.5 mm Console WARNINGS/PRECAUTIONS: • WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation. • Ensure the PV Console display is visible during the entire procedure. • Observe normal safety practices associated with electrical/electronic medical equipment. • Avoid excessive coiling or bending of the power cables during storage. • Store the PV Console using appropriate care to prevent accidental damage. • Do not place objects on the PV Console. • Do not immerse the PV Console in liquids.ADVERSE EVENTS: Potential adverse events associated with use of this device and other interventional catheters include, but are not limited to the following (alphabetical order):• Abrupt or sub-acute closure • Amputation • Bleeding complications, access site • Bleeding complications, non-access site • Death • Dissection • Distal emboli • Hypotension • Infection or fever • Perforation • Restenosis of the treated segment • Vascular complications which may require surgical repair • Thrombus Vasospasm

Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.