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JETSTREAMTM

Atherectomy/Thrombectomy in

Infrainguinal Arterial Disease:

What Makes it Different From Other Devices?

Venkatesh G. Ramaiah, MD, FACS

Medical Director Arizona Heart Hospital

Director Peripheral Vascular & Endovascular Research

Arizona Heart Institute

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Bayer HealthCare is sponsoring this

presentation. Dr. Ramaiah is presenting

on behalf of and is a paid consultant of Bayer.

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PAD The Unmet Challenge

Extension / Contraction

Torsion

Compression

Flexion

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Freeze it

Subintimally dissect it

Stent it

Balloon it

Excise it Lase it

PAD

Spin it

Cover it

JET it

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Terrain Challenges in the Lower Extremities

• Long, diffuse lesions

• Often calcified

• Concomitant disease

• Occlusions common

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Stenting of the Femoro-

Popliteal Segment:

“The Dark Side and Implications”

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In the

ABSOLUTE trial,

stents superior

to PTA at 12

months

NEJM 2006;354:1879-88

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J Endovas Ther 2004;11(suppl II):II-107-II-127

Lower Extremity Endovascular Interventions Bates and AbuRahma

Long Term PAD Treatment Results

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Type I Stent Fracture

• Single fracture of

stent strut

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Type II Stent Fracture

• Multiple fracture

of stent struts

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Type III Stent Fracture

• Complete linear stent fracture without displacement

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Type IV Stent Fracture

• Class III with

displacement of

stent

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The challenges of physical force

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SFA STENTING IS A BAILOUT

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Preserve Your Options

“LEAVE NOTHING BEHIND”

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Atherectomy –

A front line therapy

• Preserves future options

• Leaves nothing behind

• Facilitates low pressure angioplasty

• Minimize barotrauma to arterial wall

• Does not prevent surgical bypass or

change surgical distal target

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PAD will Progress

Preserve options/less invasive

Decreasing options/irreversible

Healthy

Leg

PAD screening /

Rx management Death Angioplasty/

Atherectomy Stenting Bypass Amputation

Decisions today have implications tomorrow

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There is Great Debate About Optimal Interventional Therapy

Stenters vs. Debulkers

Atherectomy

Stenting

(Both evolving)

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Why JETSTREAM Atherectomy?

• Facilitates both atherectomy and

thrombectomy-- mixed morphology lesions

• Front Cutting--CTOs

• Expandable blade technology--single device

solution

• Circumferential cutting--concentric lumens

• Reduce risk of embolization--active aspiration

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JETSTREAM Atherectomy System

Console

1.6mm

1.85mm

2.1/3.0mm

Disposable

Catheter

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JETSTREAM Blades up and Down

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• Expandable blades: provide

treatment from CFA-Popliteal

• OTW front cutting

• 135cm

• 0.014"GW / 7F sheath

compatible

JETSTREAM Atherectomy Above the Knee

Blades down Blades up

2.1 mm / 3.0mm

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• 1.6 and 1.85mm

cutting tips

• OTW front cutting

• 135cm working length

• .014GW / 7F sheath

compatible

Jetstream Atherectomy Below the knee

1.85mm

1.6mm

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Initial Experience with The

JETSTREAM Atherectomy

Device for Femoropopliteal

Disease

Imran Javed, MBBS, FCPS; Venkatesh Ramaiah, MD, FACS; David Terry, MD;

Julio Rodriguez, MD, FACS; Matt Nammany, MD

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Patients & Methods

• Duration: Mar 2008 to Nov 2009 (21M).

• Total patients: 86 patients/113 lesions

• Sex: Males 55(64%) Females 31(36%).

• Age range: 36 to 87 Yrs.

• Inclusion Criterion: – All patients underwent JETSTREAM Atherectomy during this

time period regardless of their previous status.

• End point of study: – TLR, ABI’s, Duplex Patency and Safety were monitored

Presented at iCON 2009

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Clinical Findings

• Total No of Lesions: 113

• Site of Lesion:

– SFA: 74 (65.5%)

– Popliteal: 30 (26.6%)

– Other Vessels: 4 (3.5%)

– Instent Restenosis: 4 (3.5%)

– Femropopliteal Bypass: 1 (0.9%)

Presented at iCON 2009

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• Presentation: Claudication: 58 (67.4%)

Rest Pain: 13 (15.1%)

Tissue Loss: 15 (17.5%)

Diabetic patients: 42 (50%)

• Limb Involved: • Right: 32 (37%)

• Left:54 (63%)

Clinical Findings

Presented at iCON 2009

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Classification of Lesions on Basis

of TASC II Guidelines

24 23

18

13

8

0

5

10

15

20

25

30

TASC A TASC B TASC C TASC D Undefined

27.9% 26.7% 20.9% 15.1% 9.4%

Presented at iCON 2009

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Operative Findings

Type of Pathology:

Occlusion: 47 (54.7%)

Stenosis: 27 (31.4%)

Both: 12 (13.9%)

Distal Run Off:

Single Vessel: 43 (50%)

Double Vessel: 31 (36%)

Triple Vessel: 3 (3.5%)

Collaterals: 9 (10.5%)

Presented at iCON 2009

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JETSTREAM Atherectomy of Severe Calcific Popliteal Stenosis

Severe calcific 90%

stenosis of the popliteal

artery across the knee joint

Excellent post JETSTREAM atherectomy results,

without dissection, PTA or embolization

Presented at iCON 2009

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Results

• Freedom from TLR was 78% at one year

• Reintervention was more common in first 3

months after first intervention (learning curve)

• Thrombectomy capabilities were essential in 16%

of cases

• Adjunctive balloon angioplasty was 68% and

stents were used in 7%

• Primary patency was 72% (Duplex) in one year

Presented at iCON 2009

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Types of Re-interventions

Balloon Angioplasty ± Stent: 7 (6.1%)

Remote Endarterectomy/Fem-pop Bypass: 4 (3.5%)

Repeat Atherectomy +Angioplasty: 13(11.5%)

Below Knee Amputation: 1 (0.8%)

Presented at iCON 2009

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Conclusion

• The JETSTREAM device with thrombectomy and

aspiration capabilities has added advantages to femoro-

popliteal atherectomy.

• Low embolization (1.7%) and dissection (0.88) rates

• Adjunctive stenting remains very low in this difficult

segment

• Long term follow up will definitely be needed for

durability and patency

Presented at iCON 2009

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The Credo in SFA Total Occlusions

Debulk rather than displace obstructive

material creating an increase in luminal gain.

Leaving options open for future treatment

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Pathway PVD Study

Patient Characteristics (n=172)

Mean age (years) 71.9

Male 49%

Diabetes mellitus 47%

Smoking within last 90 days 31%

Hypercholesterolemia 69%

Family Hx Coronary artery disease 23%

Hypertension 94%

Prior lower limb revascularization 51%

Rutherford Classification:

1 5%

2 17%

3 64%

4 5%

5 10%

J ENDOVASC THER 2009;16:653–662

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Pathway PVD Study

Lesion Characteristics (n=210)

Average reference vessel 3.7mm (2.1mm-6.1mm)

Average lesion length 3.5cm (0.7cm-14.7cm)

Moderate to high calcium 51%

Total occlusion 31%

Target Lesion Location:

SFA 64%

Popliteal 28%

Tibial/Peroneal 9%

J ENDOVASC THER 2009;16:653–662

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Pathway PVD Study

Procedural Outcomes (n=210)

Device success rate^ 99%

Mean PVS activation time 3.5 min (range 0.5-12.9)

Average diameter stenosis*

Pre-treatment 79%

Post Pathway 35%

Post adjunctive 21%

Adjunctive treatment

None 34%

Balloon angioplasty 59%

Stent 7% ^ Defined as crossing and debulking lesion (208/210 lesions) * Per lesion based on angiographic results measured by core lab

J ENDOVASC THER 2009;16:653–662

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Outcomes

Pathway PVD Study ABI improvement

N Mean

Baseline 159 0.59

Discharge 150 0.88

30 Day 149 0.90

6 Month 138 0.77

12 Month 109 0.82

N Mean

Baseline 169 3.0

30 days 142 1.2

6 months 135 1.5

12 months 110 1.5

Pathway PVD Study - Rutherford Classification

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J ENDOVASC THER 2009;16:653–662

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6 and 12 Month Freedom From TLR

85%

74%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

6 months

12 months

Mean time follow-up (months)10.5

J ENDOVASC THER 2009;16:653–662

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Diabetic vs. Non Diabetic Results

12 Month

0%

5%

10%

15%

20%

25%

30%

Diabetics 1.30% 1.30% 20.00% 3.80% 2.50%

Non- Diabetics 1.10% 1.10% 28.30% 5.40% 0.00%

Death MI TLR TVR Amputation

Ann Vasc Surg 2011; 25: 520-529

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12 Month Freedom from TLR-

Diabetic vs Non-Diabetic

80.00%

71.70%

66%

68%

70%

72%

74%

76%

78%

80%

82%

12 month

Non-DM DM

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Ann Vasc Surg 2011; 25: 520-529

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PVD Study Conclusion

• The device appeared to be safe based on a low incidence

of MAE.

• 99% device success rate

• High procedural success and significant improvement in

Rutherford and ABI at 30 days, 6 months and 1 year.

• 93% of cases performed as a stand-alone or adjunctive

balloon-angioplasty procedure.

• The device was effective with an 85 and 74 percent

freedom from TLR at 6 and 12 months respectively.

• Results similar for diabetic and non-diabetics

J ENDOVASC THER 2009;16:653–662

Ann Vasc Surg 2011; 25: 520-529

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Atherectomy – When to use

Conclusions

• Different for all lesion morphologies – preserving

future options

• Debulking reduces the need of stents

• Initial diabetics data shows benefit from debulking

• Debulking prior to local drug delivery might become

the future of endovascular treatment

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JETSTREAM Atherectomy – Where to use

• Calcified lesions

• Total occlusions with mixed composition

of occlusive material (e.g. thrombus)

• Diabetic patients

• Preparation of the artery for definitive

therapy

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SO !!! WHY JETSTREAM??

• One device to treat different plaque morphologies (calcium/plaque/thrombus)

• Treat multivessel disease with single catheter (aspiration and cutting)

• Quickly restoring flow

• Debulking – preserve future options

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SFA CTO

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No-Stent Zone

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Another No-Stent Zone

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Recorded Live Case

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JETSTREAM Case of the Day Dr. Venkatesh Ramaiah, Arizona Heart Institute 11/18/2008

• 5mm Occluded Popliteal.

• 3 Passes Blades-up, 2 Passes Blades-down.

• 5x40 mm POBA Post-Dilation.

• JETSTREAM Runtime 5:41

Post 5x20mm POBA

Post 5x20mm POBA

Popliteal

Occlusion

Post

Jetstream

Post 5x40mm

POBA

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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. See product Information for Use for specific and complete

prescribing information.

Indications, operating specifications and availability may vary by country. Check with

local product representation and country-specific Information for Use for your

country

Bayer, the Bayer Cross, JETSTREAM, Navitus and JETSTREAM G3 are

trademarks of the Bayer group of companies.

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Questions?

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