jetstream atherectomy system...*eurointervention 2015;11:96-103, jetstream calcium study 4...

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Jetstream™ Atherectomy SystemIn-Service Presentation

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Jetstream™ Atherectomy System

IMPORTANT INFORMATION

These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain conditions. Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case. As always, decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand.

BSC does not promote or encourage the use of its devices outside their approved labeling.

Prior to use, please refer to full DFU for indications, contraindications, warnings/precautions, adverse events and complete operating instructions.

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Jetstream Atherectomy System

The industry’s most versatile debulking solution• Demonstrated effectiveness in most lesion morphologies – including severe

calcium*

• Indicated for atherectomy and thrombectomy in peripheral arteries

• The only atherectomy device with active aspiration

• Front cutting – provides an effective solution for total occlusions

• Rotational Cutting – Facilitates creation of concentric lumens

and laminar flow

*EuroIntervention 2015;11:96-103, Jetstream Calcium Study

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Managing PAD

The Progression Of PAD and The Options For Treatment

Preserving options for the PAD Patient

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PVD Treatment Zones

Above-the-Knee Disease

• Mixed Morphology

(calcium, plaque & thrombus)

• Tortuous, challenging anatomy

• Medium to large vessels

(4-9mm)

Below-the-Knee Disease

• Calcium is highly prevalent

• CLI patients, often trying to avoid

amputation

• Small vessels (3.5 – 1.5 mm)

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Jetstream XC Systems

Two sizing options in a single device

(eXpandable Cutter)

Rotational/differential cutting tip removes all plaque types

Active Aspiration ports collect plaque & thrombus

135 cm and 120 cm OTW lengths

.014GW / 7F sheath compatible

Ergonomic design for enhanced

user controls

Intuitive user interface facilitates single operator use

Improved wire GARD* simplifies wire management

XC 2.1/3.0 mm

XC 2.4/3.4 mm

XC 2.1/3.0 mm

XC 2.4/3.4 mm

eXpandable Cutter

* Compared to previous generation

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Jetstream SC Catheters

Single Cutter technology for

tortuosity

Rotational/differential cutting tip removes all plaque types

Aspiration ports collect plaque & thrombus

145 cm OTW

.014GW / 7F sheath compatible

SC 1.85 mm

SC 1.6 mm

SC 1.85 m

SC 1.6 mm Ergonomic design for

enhanced user experience

Intuitive user interface facilitates single operator use

Improved wire GARD*

simplifies wire management

Single Cutter


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JETSTREAM Catheter

Minimum Vessel Diameters

Confirm the Minimum Vessel Diameter Proximal to the Lesion

Minimum Vessel Diameter Blades Down 3.0 mm

Minimum Vessel Diameter Blades Up 4.0 mm


Minimum Vessel Diameter Blades Up 4.5 mm



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Jetstream System Setup

Prior to use, please refer to full DFU for indications, contraindications, warnings/precautions, adverse events and

complete operating instructions.

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Jetstream XC and SC Atherectomy

Systems Instructions for Use

Review of key items

Procedures supplies

• Use room temperature saline only

Catheter and Control POD Set-up

• Verify that no air bubbles are exiting the distal catheter tip at the end of the prime cycle

Procedure (note)

• Maintain flat surfaces of Control POD oriented horizontally. Some leakage from Control POD vent holes on bottom flat surfaces is normal.

Treatment

• Caution: 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 region of the guidewire may

cause damage to or detachment of the guidewire tip or complicate guidewire management.

• (Step 3) Using fluoroscopic guidance, advance the Catheter Tip deliberately and slowly across

the treatment area at a rate of approximately 1 mm per second. The Catheter should never be

forced or pushed through the lesion.

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Catheter Selection

Jetstream Catheters – 4 models to choose from

• XC – Expandable Cutter – 2.4/3.4

– 2.1/3.0

• SC – Single Cutter – 1.85

– 1.6

Jetstream Catheters offer

Active aspiration

Concentric cutting solution

Differential cutting

XC catheters offer expandable blades option Indication for Atherectomy and Thrombectomy

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Opening the Jetstream Catheter

Sterile Packaging

Using standard sterile technique, open

by peeling back outer packaging

barrier and hand off to sterile person

Removing the Tyvek® Lid

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After Tyvek® Lid is peeled back

Place tray on procedure table

EITHER

• Lift Control POD and catheter out of

the tray, keeping in the sterile field

and handing off the remaining components in the tray to the

circulator

Or

• Empty contents on sterile field

(consider tray orientation to

minimize POD drop)

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Review – Jetstream Setup

1. Attach the Jetstream console to an IV pole

2. Plug in – power up

3. Load the baton into the pump

4. Spike the saline

5. Connect the catheter and waste bag

6. Prime the catheter

7. Load the catheter over the guidewire, deliver to treatment

zone* and position guidewire in the GARD

* Unit will not operate without Guidewire

in the GARD

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Jetstream Console Setup

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Schematic Illustration

The console provides power to the

POD and saline for infusion. It also

manages infusion and aspiration

with monitoring run time.

• The console does not require

preventative maintenance or

calibrations.

• The console plugs into a standard 120V outlet.

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Mount console on IV pole

The console requires an IV pole to

position it near the patient, yet outside

the sterile-field

• Console is mounted on IV pole with

clamp located on the back of the unit.

IV poles with 5 “feet” at the bottom provide

best stability.

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1. Bubble Detector Reset and Infusion LED

Resets the Bubble Detector. Infusion LED turns green when Prime

is complete

2. Display Mode Button

Toggles the information on the display between: total run time, min

run time, max run time, and milliamps

3. Main Power ON/OFF

Press to turn Console ON and OFF

4. Prime Button and Indicator LED

Initiates and pauses the priming process. LED flashes orange to

prompt priming and turns off when prime is complete

5. Minimum Tip Size Indicator

Catheter tip is at Minimum Size (2.1mm)

6. Maximum Tip Size Indicator

Catheter tip is at Maximum Size (3.0mm)

7. Elapsed Run Time Display

Timer displays the elapsed run time for the Catheter

Jetstream Console Interface Symbols

1

45 6

7

3

2

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Setting up the Console

• With the Jetstream Catheter selected – Turn on the Jetstream Console with the doors closed

– Open the doors and insert the baton insuring the tubing fits over the roller pumps

– Close the doors and spike the room temperature saline bag

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Install tubing into the bubble detector

With the catheter installed and the saline spiked, install the tubing into the bubble

detector – use a flossing motion to insure that the tubing is fitted securely and to

the back

Bubble detector

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Connecting the Catheter

With the Baton in place, and saline spiked…

Next-

Hang the waste bag on the console pegs

And

Connect the power cord,

Red Dot to Red Dot

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Prime the System

• With the catheter loaded and saline spiked, the prime light will be lit

• Place the tip of the catheter in a bowl of saline keeping the tip of the

catheter away from the sides and the bottom of the bowl

• Depress the PRIME button – the system will begin the prime cycle,

stopping when complete

Following prime, the system is ready to be back-

loaded over the wire for the procedure

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Jetstream Catheter and POD

Design and Operation

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The Jetstream Catheter and POD

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Jetstream XC and SC Catheter PODS

POD design

• Ergonomically designed for ease of use

• Clearly labeled buttons for activation

• Removable tethered controls for operational flexibility

• Convenient access to controls – Blades

up/Down, activation and REX

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Activation Handle Interface Symbols

For Jetstream XC and SC Catheter

Jetstream XC Jetstream SC

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Jetstream Atherectomy Systems

Caution• 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.

Compatible Introducers• 7F or larger with minimum inner diameter of .098 in or 2.5 mm

• Do not use Tuohy Borst valve type introducers

Sheath Compatibility

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Guidewire Compatibility

Wire Compatibility

Caution

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.

Compatible Boston Scientific Guidewires

• Boston Scientific Thruway™ .014 in (.36 mm) 300 cm

• Boston Scientific Jetwire™ .014 in (.36 mm) 300 cm

• Use over an approved 0.014 exchange length guidewire

• Do not use over a wire if kink is present

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Loading over the wire and insertion into the

Guidewire Anti-Rotational Device (GARD)

1. Backload the Jetstream Atherectomy Catheter

over the wire

2. With the wire exiting the back of the POD

• Grasp the POD from below, depressing

the silver GARD button to enable

guidewire insertion angled channel

• Fully insert the wire into the angled

channel from the back of the POD and release the GARD button

• Insure the wire is secure and the loop is

tight

Do not to kink the wire during loading, operating

over a kinked wire may cause the device to lock

on the wire.

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Jetstream Guidewire loop size

• When loading the

Guidewire into the

GARD, ensure that

the wire loop is tight

• Wire loop will grow

and shrink in length

as the catheter is

advanced and

withdrawn

• No adjustment

should be

necessary during

procedure

Example of starting wire

loop too large Starting size for wire loop

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Wire holder for proximal wire management

Wire placed in wire holder

to control direction of excess wire

Wire out of the holder

Wire holder helps direct the excess wire segment down, keeping it

in the sterile field and not interfering with the operator

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Jetstream Catheters

4 catheters to choose from

• Jetstream XC 2.4/3.4 120cm• Dual Cutting Expandable Blades

• Active Aspiration

• ATK larger vessels

• Jetstream XC 2.1/3.0 135cm• Dual Cutting Expandable Blades


• ATK distal

• Jetstream SC 1.85 145cm • Single Cutter – Front end cutting


• BTK use

• Jetstream SC 1.6 145cm • Single Cutter – Front end cutting


• BTK use

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Jetstream Catheter design

Infusion Front End Cutting

Jetstream XC

Jetstream SC

Expandable Blades

Aspiration

Jetstream Catheters offer:

• Differential cutting

• XC Expandable blade technology


• Circumferential rotational clearance

• Front end cutting

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Procedural Recommendations

• Always operate the Jetstream Catheter over an approved 0.014 exchange length guidewire

• When activating the Jetstream Catheter in a cutting mode advance only in a proximal to distal motion

• Complete two passes blades down followed by two passes blades up

• Advancement speed should be no faster than 1mm per second or using an engage –disengage technique listening to the motor RPMs

• REX back following each forward pass, providing active aspiration

• Avoid stalling the device when treating the occlusion

• Monitor the outflow of the device – if outflow is lost, stop and clear before continuing procedure

• Always keep the tip of the Jetstream Catheter back 10cm from the guidewire spring tip

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Troubleshooting

• The Jetstream console monitors the system during operation. If an error occurs, the display will note an error code. Always refer to the set-up guide to identify the error and steps to resolve

Examples

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Jetstream System Advantage

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Catheter Evolution

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Thruway™ Guidewire .014"

• Thruway .014 in 300 cm (M001492971) has been added to the Jetstream System DFUs as a compatible wire

(Section 8.1 “Procedure Supplies”)

• Product details:– Tip design: flexible spring coil tip

– Core: highly supportive stainless steel shaft

– Coating: Silicone (non-hydrophilic)

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Rotaglide™ Lubricant

Atherectomy Lubricants are now indicated for use with the Jetstream Atherectomy System, for the purpose of increasing lubricity of the system.

– Injected into flush bag (20 cc vial per 1000 cc saline bag)

– Intended to reduce Aspiration Line Clogging

– Ingredients: Olive oil, egg yolk

phopholipids, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, water

– Does not require refrigeration

– Contraindicated if patient is allergic to eggs or olive oil

*Testing completed by Boston Scientific Corp. Data on file (D1991). Bench test results may not necessarily be indicative of clinical

performance.

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Indications & Contraindications

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.

CONTRAINDICATIONS

• No known contraindications

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Special Patient Populations

The safety and effectiveness of the Jetstream System has not been established in

the following patient populations:

• Patients with an uncontrollable allergy to nitinol, stainless steel, other stent materials or to contrast agents.

• Patients unable to take appropriate anti-platelet therapy.

• Patients with no distal run-off.

• Patients with in-stent restenosis at the peripheral vascular site.

• Patients with target vessels that have moderate or severe angulation (e.g. >30 degrees) or tortuosity at the treatment segment.

• Patients with a history of coagulopathy or hypercoagulable blood disorder.

• Patients receiving hemodialysis or with impaired renal function (creatinine is > 2.5 mg/dl) at

the time of treatment.

• Patients with evidence of intracranial or gastrointestinal bleeding within the past three months.

• Patients with severe trauma, fracture, major surgery or biopsy of a parenchymal organ within

the past 14 days.

• Patients who are pregnant or nursing a child.

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Jetstream™ Atherectomy System

Abbreviated Statement

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.

JETSTREAM CATHETERS COMBINED WITH CONSOLE

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 low er 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 w ith 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 know n

contraindications. CATHETER WARNINGS/PRECAUTIONS: • The Jetstream Catheter and Control Pod may only be used w ith the PV Console. • Take care to avoid being pinched

w hen closing the aspiration and infusion pump doors. Use room temperature infusate only. Use of heated infusate may lead to w rinkling, 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 guidew ire may cause vessel damage or guidew ire fracture. • During treatment, do not allow the Catheter tip w ithin 10.0 cm of spring tip portion of the guidew ire. Interaction betw een the

Catheter Tip and this portion of the guidew ire may cause damage to or detachment of the guidew ire tip or complicate guidew ire management. • The guidew ire must be in place prior to

operating the Catheter in the patient. Absence of the guidew ire may lead to inability to steer the Catheter and cause potential vessel damage. • Do not inject contrast w hile the device is

activated. • If the guidew ire is accidentally retracted into the device during placement or treatment, stop use, and remove the Catheter and the guidew ire from the patient. Verify that the

guidew ire is not damaged before re-inserting the guidew ire. If damage is noticed, replace the guidew ire. • Check the infusate bag frequently and replace w hen needed. Do not run the JETSTREAM System w ithout infusate as this may cause device failure. • Hold the guidew ire f irmly during Catheter retraction process. Failure to do so may result in guidew ire rotation

w ithin the vessel. • Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined. • Use only listed compatible guidew ires and introducers

w ith 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

Dow n 3.0 mm; Minimum Vessel Diameter, Blades Up 4.0 mm; Jetstream XC Atherectomy Catheter2.4-3.4 Minimum Vessel Diameter, Blades Dow n 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 w ith 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 w ill halt device activation. • Ensure the PV Console display is visible during the entire procedure. • Observe normal safety practices associated with electrical/electronic medical equipment. • Avo id excessive coiling or bending of the pow er 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 follow ing (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 w hich may require surgical repair • Thrombus • Vasospasm

Jetstream is a registered or unregistered trademark of Boston Scientif ic Corporation or its aff iliates.

© 2015 Boston Scientif ic Corporation or its aff iliates. All rights reserved.

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Rotablator™ Rotational Atherectomy System

Abbreviated Statement

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 “Directions for Use” for more information on

Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Rotalink Plus INTENDED USE/INDICATIONS FOR USE

The Rotablator Rotational Atherectomy System is intended for percutaneous use in the peripheral vessels in patients w ith occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.

RotaWire: INDICATIONS FOR USE/INTENDED USE

These guidew ires are intended for use w ith the Rotablator Rotational Atherectomy System.

Lubricant INDICATIONS FOR USE

Rotaglide lubricant is intended for use w ith the Rotablator atherectomy system, for the purpose of increasing the lubricity of the system.

CONTRAINDICATIONS AND RESTRICTIONS

Contraindications

1. Occlusions through w hich a guidew ire will not pass.

2. Use in coronary arteries.

3. Long (≥ 20 cm) total occlusions.

4. Angiographic evidence of thrombus prior to treatment w ith the Rotablator Rotational Atherectomy System. Such patients may be treated w ith thrombolytics (e.g., Urokinase). When the thrombus has been resolved for tw o to four weeks, the lesion may be treated w ith the Rotablator Rotational Atherectomy System.

5. Angiographic evidence of signif icant dissection at the treatment site. The patient may be treated conservatively for approximately four weeks to permit the dissection to heal before treating the lesion w ith the Rotablator Rotational Atherectomy System.

Lubricant CONTRAINDICATIONS

Rotaglide™ lubricant is contraindicated in patients w ith know n allergies to the lubricant ingredients: olive oil, egg yolk phospholipids, glycerin, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and w ater.

Restrictions

• Federal (USA) law restricts the use of this system to physicians w ho are credentialed in peripheral angioplasty and w ho have attended the Rotablator System Physician Training Program.

44 PI-280308-AA SEPT2015


Abbreviated Statement (Continued)

WARNINGS

• The risks of Rotational Atherectomy can be reduced if the device and associated accessories are used in the appropriate pat ient population by a physician w ho has had adequate

training.

• If the Peripheral RotaLink Plus show s evidence of mechanical failure at any time prior to or during the angioplasty procedure, immediately discontinue use of the device and return it to

Customer Service for evaluation. Do NOT attempt to use a damaged Peripheral RotaLink Plus; use may result in device malfunction and/or patient injury.• Never operate the Peripheral RotaLink Plus w ithout saline infusion. Flow ing saline is essential for cooling and lubricating the w orking parts of the advancer. Operation of the advancer

w ithout proper saline infusion may result in permanent damage to the advancer.

• Never operate the Peripheral RotaLink Plus w ith the Rotablator Rotational Atherectomy System in Dynaglide™ mode or operate the guidew ire brake defeat button unless you have a

f irm grip on the guidew ire using the w ireClip™ Torquer. The w ireClip Torquer may be held w ith the f ingers or inserted completely into the docking port after the brake button is

depressed. Defeating the brake, or operating the Peripheral RotaLink Plus w ith the Rotablator Rotational Atherectomy System in Dynaglide mode, w ithout securing the guidew ire may result in rotation and entanglement of the guidew ire.

• During setup of the Peripheral RotaLink Plus never grip or pull on the f lexible shaft.

• The burr at the distal tip of the Peripheral RotaLink Plus is capable of rotating at very high speeds. Do NOT allow parts of the body or clothing to come in contact w ith the burr. Contact

may result in physical injury or entanglement.

• Never advance the rotating burr to the point of contact w ith the guidew ire spring tip. Such contact could result in distal detachment and embolization of the tip.• If the Peripheral RotaLink Plus stops and the red STALL light on the console illuminates, retract the burr and immediately discontinue treatment. Check the advancer for proper

connection to the console. If the connections are correct, use f luoroscopy to analyze the situation. Never force the system w hen rotational or translational resistance occurs, as vessel

perforation may occur.

• Never advance the rotating burr by advancing the sheath. Guidew ire buckling may occur and perforation or vascular trauma may result. Alw ays advance the rotating burr by using the

advancer knob.• If resistance is encountered, retract the burr and stop treatment immediately. Use f luoroscopy to analyze the situation. Never force the Peripheral RotaLink Plus w hen rotational or

translational resistance occurs, as vessel perforation, vessel trauma or embolism due to burr detachment or fractured wire may occur and in rare instances may result in surgical

intervention and death.

• The use of Rotablator Rotational Atherectomy System for in-stent restenosis might lead to damage of stent components and/or Peripheral RotaLink Plus, w hich may lead to patient

injury.• Alw ays keep the burr advancing or retracting w hile it is rotating. Maintaining the burr in one location w hile it is rotating may lead to excessive tissue removal or damage to the

Peripheral RotaLink Plus or entrapment of the Peripheral RotaLink Plus. It is best to advance and retreat the burr no more than 3 cm at a time in a smooth pecking motion, being careful

to engage the lesion only minimally w hen resistance is met. Do not allow the individual burr run time to exceed 30 seconds w ith total rotational procedure time not to exceed five

minutes.

RotaWire WARNINGS

Use extreme caution and careful judgment in patients for w hom anticoagulation is not indicated. Console WARNINGS

• Never use oxygen as the propellant for the Rotablator Rotational Atherectomy System.

• The use of accessories, transducers and cables other than those specif ied, w ith the exception of transducers and cables sold by the manufacturer of the Rotablator System as

replacement parts for internal components, may result in increased emissions or decreased immunity of the Rotablator System.• This device is not to be used in the presence of f lammable anesthetics.

• Do NOT operate the Rotablator Console w ith gas pressures in excess of 758.4 kPa (110 psi).

• Do not modify or repair.

Lubricant WARNINGS Discard v ial if there are particulates in the emulsion or if an oiling-out of emulsion has occurred.

45 PI-280308-AA SEPT2015


Abbreviated Statement (Continued)PRECAUTIONS

• Percutaneous rotational angioplasty with the Rotablator Rotational Atherectomy Sy stem should only be carried out at hospita ls where emergency by pass surgery can be immediately perf ormed in the ev ent of a

potentially injurious or lif ethreatening complication.

• Appropriate drug therapy including (but not limited to) anticoagulant and v asodilator therapy must be prov ided to the patient during all phases of patient care.

• When the Peripheral RotaWire™ Guidewires and/or Peripheral RotaLink Plus are in the body , they should only be manipulated while they are under f luoroscopic observ ation with radiographic equipment that

prov ides high resolution images.

• Use only normal saline as the inf usate. Nev er inject contrast agent, or any other substance that is not approv ed as part of the Rotablator Rotational Atherectomy Sy stem, into the inf usion port or saline inf usion

bag as this may cause permanent damage to the Peripheral RotaLink Plus.

Console PRECAUTIONS

• User should take precautions when using the console in conjunction with other medical electrical equipment.

• The Rotablator Console needs special precautions regarding EMC and needs to be installed and put into serv ice according to the EMC inf ormation prov ided in Appendix D in the DFU.

ADVERSE EVENTS

Potential adv erse reactions which may result f rom the use of this dev ice include but are not limited to:

• Additional interv ention

• Allergic reaction

• Amputation

• Death

• Embolism

• Hematoma/Hemorrhage

• Hemody namic changes

• Hemoglobinuria

• Inf ection

• Restenosis

• Stroke

• Slow, no f low, abrupt v essel closure

• Surgery including arterial by pass

• Thrombosis and v essel occlusion

• Vessel trauma (dissection, perf oration, psudoaneury sm, arteriov enous f istula)

There may also be complications associated with distortion, kinks, and f racture of the guidewire and phy sical deterioration or malf unction of the dev ice, which can lead to patient injury or death.

Rotablator, RotaLink, and RotaWire are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.© 2015 Boston Scientific Corporation or its affiliates. All

rights reserved.

46 PI-280308-AA SEPT2015

Rotaglide Lubricant Abbreviated Statement

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 “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE

• Rotaglide lubricant is intended for use with the Rotablator atherectomy system, for the purpose of increasing the lubricity of the system.

• The Indications for Use of the Rotablator system remain unchanged.

CONTRAINDICATIONS

• Rotaglide™ lubricant is contraindicated in patients with known allergies to the lubricant ingredients: olive oil, egg yolk phospholipids, glycerin, sodium deoxycholate, L-histidine, disodium EDTA, sodium hydroxide, and water.

WARNINGS

• Discard if any are found. Discard vial if there are particulates in the emulsion or if an oiling-out of emulsion has occurred.

PRECAUTIONS

• Careful consideration should be given to additions of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability.

47 PI-280308-AA SEPT2015

Appendix

48 PI-280308-AA SEPT2015

Jetstream XC

Product Specifications

SpecificationsJetstream XC

2.1/3.0mm

Jetstream XC 2.4/3.4mm

Infusion Rate Blades Down (mL/min) 43* 47*

Infusion Rate Blades Up (mL/min) 33* 36*

Aspiration Rate, Blades Down (mL/min) 40* 51*

Aspiration Rate, Blades Up (mL/min) 44* 49*

Target Operating Speed (kRPM) 70 70

Tip Size (mm) 2.1/3.0 2.4/3.4

Catheter Length (cm) 135 120

Maximum Catheter Profile (mm) 2.5 2.4

Introducer Compatibility (Fr) 7 (.098 min ID) 7

Max Guidewire Diameter (inches) .014 .014

* Nominal

49 PI-280308-AA SEPT2015

Jetstream SC

Product Specifications

SpecificationsJetstream SC

1.6 and 1.85mm

Infusion Rate Blades Down (mL/min) 20*

Infusion Rate Blades Up (mL/min) n/a

Aspiration Rate, Blades Down (mL/min) 16*

Aspiration Rate, Blades Up (mL/min) n/a

Default Operating Speed BD (kRPM) 73

Default Operating Speed BU (kRPM) n/a

Tip Size (mm) 1.85 and 1.6

Catheter Length (cm) 145

Maximum Catheter Profile (mm) 2.33

Introducer Compatibility (Fr) 7

Max Guidewire Diameter (inches) .014

50 PI-280308-AA SEPT2015

Instructions for Use –

PREPARATION FOR USE

CONSOLE SETUP

1. Remove the device tray from the packaging using aseptic technique and place in the sterile field.

2. Carefully remove the lid on the tray.

3. Hand off the electrical connector, tubing and Baton to the circulating assistant outside the sterile field.

4. Remove any packaging coils and retainers from the Catheter.

5. Press the Main Power On/Off button on the upper right front comer of the PV Console to tum the main power on.

6. Connect the electrical cable from the Control Pod to the Control Pod Power Connector on the PV Console. Verify that the dot on the Control Pod Power Connector is aligned with the dot on the PV Console Connector.

7. Open the pump doors and insert the Baton such that the tubing is located over the pump rollers. Press the tubing onto the center of the pump rollers. See TUBING INSERTION DIAGRAM. The Collection Bag should be hanging down if the Baton is oriented properly.

8. Close the pump doors and hang the Collection Bag from the hooks located below the pumps . Caution: Take care to avoid being pinched when closing the aspiration and infusion pump doors.

9. Insert the infusion tubing's bag spike into a bag of normal saline solution using aseptic technique and hang the bag from the pegs on the IV stand.

10. Caution: Use room temperature saline only. Use of heated saline may lead to wrinkling, ballooning and/or bursting of the outer Catheter sheath.

11. Insert the infusion tubing into the Bubble Detector. See BUBBLE DETECTOR INSERTION.

12. Be sure that the aspiration and infusion tubing is free of kinks and pinch points.

13. Confirm that the Catheter is set to Minimum Tip diameter (Blades Down) by verifying the Min Tip Size indicator is lit on the PV Console.

Caution: Do not bend or kink the Catheter during setup or during the procedure. This may damage the device and lead to device failure.

51 PI-280308-AA SEPT2015

Instructions for Use

Priming the System

1. Carefully place the Catheter Tip in a sterile bowl of saline. Do not allow the Catheter Tip to touch the bottom or sides of the bowl. Damage may occur if the tip comes in contact with the bowl during priming.

2. Press the Prime button on the PV Console. The tip of the Catheter must remain immersed in saline during the entire priming cycle. Whenthe priming cycle is complete, the PV Console will beep and the Infusion LED on the PV Console will be green.

3. Verify that no air bubbles are exiting the distal catheter tip at the end of the prime cycle.

4. If the priming cycle does not complete successful, press the Prime button on the PV Console again and repeat the priming cycle.

5. Insert a guidewire into the GARD clamp. The Jetstream System will not operate if a guidewire is not placed in the GARD clamp.

6. Press the Max Switch and verify the Maximum Tip Size indicator on the PV Console is illuminated.

7. Press the Min Switch and verify the Minimum Tip Size indicator on the PV Console is illuminated.

8. With the Catheter lip immersed in saline, depress and hold down the Activation Switch. Confirm that the Catheter lip is spinning b y observing movement of saline in the bowl.

9. Release the Activation Switch. To avoid introducing air into the system, do not remove the Catheter lip from the bowl of saline until flow has completely stopped moving in the aspiration tubing.

10. Once flow has stopped moving in the aspiration tubing, the Catheter Tip can be removed from the bowl of saline.

52 PI-280308-AA SEPT2015

Confirm integrity of collection

bag connection

• Confirm integrity of Luer Lock connection between collection tubing and collection bag prior to priming the device

53 PI-280308-AA SEPT2015

Jetstream XC and SC Catheters

54 PI-280308-AA SEPT2015

Jetstream SC/XC Family

• Ergonomic design with 32% smaller POD* to enhance the user experience

• Intuitive user interface facilitates single operator use

• Improved wire GARD* simplifies wire management

• Package and POD design reduces environmental footprint


55 PI-280308-AA SEPT2015

Guidewire Management

• Load wire, keeping a tight loop• Wire will grow and shrink in length as

the catheter is advanced and withdrawn

• Keep loop size as tight as possible –no more guessing on loop size

• No adjustment should be necessary during operation

jetstream atherectomy system...*eurointervention 2015;11:96-103, jetstream calcium study 4...

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