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Jetstream™ Atherectomy System
- Overview
- Case studies
- Clinical data
- Technical specifications
- Ordering information
- Training
- Resources
JetStream Atherectomy System
Jetstream rotational atherectomy is engineered to predictably treat real-world lesions. Patients with PAD display a wide range of lesion characteristics such as long, diffuse disease and CTOs — which often include mixed morphologies like calcium, plaque and thrombus. Jetstream is the only atherectomy device designed to treat it all.
How it works
JetStream mechanism of action explained
Why choose JetStream
- Active Aspiration: extracts debris without device removal, minimizing embolization risk.
- Debulking: to treat multiple lesion morphologies, including calcium, plaque or thrombus.
- Luminal Gain: As reported in the Calcium Study, Jetstream's front-cutting, expandable blades created statistically significant luminal gain in severe and moderate calcium (post versus baseline IVUS measurements)1.
- Front-cutting: to immediately engage tight or occluded lesions.
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References:
1. Jetstream Calcium Study.
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
CLI Case Studies
CLI Case Study 1: Complex Revascularization of Critical Limb Ischemia Patient Using Rotational Atherectomy
Dr. Jihad Mustapha demonstrates treatment of a 220 mm CTO in patient with history of CLI, utilizing antegrade and retrograde dual access with rotational atherectomy.
CLI Case Study 2: SFA Total Occlusion in Patient with Non-Healing Ulcer
Dr. Fadi Saab demonstrates atherectomy of a CLI patient presenting with a long SFA chronic total occlusion in the left leg, which reconstituted at the proximal popliteal.1
CLI Case Study 3: Thrombotic Lesion in Popliteal Artery and Tibial Vessels
Dr. Fadi Saab demonstrates atherectomy of a CLI patient presenting with rest pain in right lower extremity. Atherectomy with aspiration was used to remove thrombus in the Popliteal Artery and Tibial vessels, utilizing alterative access techniques. 30-day arterial duplex showed normalization of patient's ABI and triphasic blood flow through SFA/Popliteal and PT arteries.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
References:
1. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Clinical information
- The JET Registry
- The JET-SCE
- Jetstream Calcium Study
The JET Registry1
Objective
The JET Registry observed the treatment effects of the Jetstream™ Atherectomy System in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries.
Patient and Lesion Characteristics
JET Registry patients had real-world, long, femoropopliteal lesions and slightly over one-third were occluded. Calcium was visible in 90% of the lesions and grade 3 and 4 calcium was present in 47.7% of lesions.
Lesion Calcium Grades
| 19.5% | 4 is dense circumferential calcification along the segment length |
| 28.2% | 3 is aggregate calcification representing >50% of the segment length |
| 24.1% | 2 is aggregate calcification representing <50% of the segment length |
| 16.2% | 1 is one individual segment of vessel calcification representing <25% of the length of the entire segment |
| 10.0% | 0 is no visible calcification |
Efficacy and Outcomes
At 12 months, results showed:
* Patency based on a DUS PSVR ≤2.5; Binary Restenosis was reported as 22.8%. The JET Registry had limited DUS follow-up at 12 months (57/241 patients)
Patient Safety
JET Registry results demonstrated a strong safety profile.
Procedural Details
Catheter Sizes
- 47.2% used 2.1/3.0 mm
- 49.4% used 2.4/3.4 mm
Embolic Protection
- 22.4% of cases
Number of Passes (average*)
- 2.0 blades down
- 1.8 blades up
Jetstream Runtime (average*)
- 4.7 minutes
* Jetstream Runtime: 4.7 minutes ± 3.5 minutes; Number of Passes: 2.0 blades down ± 1.5 passes and 1.8 blades up ± 1.4 passes. There were no clear stenting parameters set, stent placement was performed at operator’s discretion, and 84 patients (35%) received adjunctive stents.
Subgroup Results
At 12 months, results showed:
Number of Patients: Non-Stent (157), Stent (84), Diabetic (99). Patency based on a DUS PSVR ≤2.5; Binary Restenosis Reported: Non-Stent: 20.5%; Stent: 27.8%; Diabetic Patients: 33.3%. The study was not powered to show differences between groups.
Summary
JET Registry data demonstrated:
- The JET Registry saw a 77.2% patency†† rate in patients with real-world, long femoropopliteal lesions (16.4 cm). No DCBs were used in this study
- There was a high freedom from TLR rate of 81.7% at 12 months
- There was a low distal embolization rate, 1.4% or 3 events
- Calcium was present in most of the lesions and grade 3 and 4 calcium was present in 47.7% of lesions
- The Jetstream Atherectomy System had a high procedural success rate, 98.3% of patients had ≤30% residual diameter stenosis post-procedure
†† Patency based on a DUS PSVR ≤2.5; Binary Restenosis was reported as 22.8%.
References:
1. Garcia, L. (2017). Jetstream atherectomy in treating de novo or non-stent restenotic femoropopliteal disease: One-year results from the JET registry. Registry results presented at the Leipzig Interventional Course (LINC), Leipzig, Germany.
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
The JET-SCE1
Long Term Outcomes with Jetstream Atherectomy System with or without Drug Coated Balloons in Treating Femoropopliteal Arteries: A Single Center Experience
Objective
The JET-SCE observed the long-term outcomes in treating femoropopliteal arteries with drug coated balloons versus plain old balloon angioplasty post Jetstream™ Atherectomy.
Patient and Lesion Characteristics
Patient Characteristics
- 81 patients
- 49.4% male
- 68.3 average age
- 53.1 % diabetic
Lesion Characteristics
- 25.9% CTOs
- 14.9 cm average lesion length in PTA cohort
- 12.0 cm average lesion length in DCB cohort
The JET-SCE included patients with de novo or restenotic femoropopliteal lesions whose symptoms were classified as Rutherford Category I-V
Results
At 12-months results demonstrated 95.2% freedom from TLR with Jetstream + DCB
Jetstream Device and Procedural Success
- 87% Device Success (<50% stenosis post Jetstream alone)
- 94% Procedural Success (<30% residual final treatment)
Minimal Luminal Diameter
- Baseline: 1.5 mm ± 1.4 mm
- Post Jetstream: 3.1 mm ± 1.2 mm
- Post Final Treatment: 4.2 mm ± 0.9 mm
Patient Procedure Details and Outcomes
- 12-months: Jetstream + DCB 95.2% freedom from TLR
- 12-months: Jetstream + PTA 69.8% freedom from TLR
- 18-months: Jetstream + DCB 91.1% freedom from TLR
- 18-months: Jetstream + PTA 63.7% freedom from TLR
- 28 patients received adjunctive DCB
- 53 patients received adjunctive PTA
References:
1. Shammas, N (2017). Long Term Outcomes with Jetstream Atherectomy System with or without Drug Coated Balloons in Treating Femoropopliteal Arteries: A Single Center Experience (JET-SCE). JET-SCE results presented as a poster at Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions, New Orleans, LA.
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Importance of Calcium Removal
- Arterial Dissections are commonly associated with plaques containing significant calcium deposits1
- Diabetic Patients have a tendency for higher calcification2
- Drug-Coated Balloon Efficacy could be impacted by calcium3
Jetstream Calcium Study4
Objective
To better understand the mechanism of lumen gain when using the Jetstream Atherectomy System to treat calcified peripheral artery lesions, i.e., patients with claudication and lesions with superficial calcium >90° and >5 mm in length as determined by intravascular ultrasound (IVUS).
Study design
Journal Articles
Key Learnings from the Calcium Study
Why is an IVUS Study Unique?
- Sensitivity to detect calcium by IVUS reported at 90%5
- Statistical ability to measure luminal gain
Primary Endpoint
Calcium removal and luminal gain, measured by comparing pre-intervention to post-atherectomy IVUS images
Treatment Device
The 2.1/3.0mm Jetstream catheter was used in all cases
Details
Results
Conclusion
Case Example from Jetstream Calcium Study
Distal SFA/Proximal Popliteal*
Successful debulking with the Jetstream Atherectomy System in a distal right SFA/proximal popliteal artery lesion. The pre-atherectomy IVUS image reveals a lumen area of 2.5 mm². The post-atherectomy images reveal a lumen area of 7.6 mm² and impressive debulking with Jetstream Atherectomy even before adjunctive therapy.
*Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
Pre-procedure CTO of right distal SFA/proximal popliteal
Final angiogram: post-Jetstream atherectomy and adjunctive PTA
Pre-procedure CTO of right distal SFA/proximal popliteal. Baseline IVUS measurement reveals area of 2.5 mm²
Standalone Jetstream result (prior to PTA) reveals an IVUS measurement of 7.6 mm²
The JETSTREAM Calcium Study was sponsored by Bayer HealthCare.
References:
1. Fitzgerald, et al. Circulation. 1992;86(1):64-70
2. Bishop PD, et al. Ann Vasc Surgery. 2008 ; 22: 799-805
3. Fanelli F, et al. Cardiovasc Intervent Radiol. 2014 ;37(4):898-907
4. Maehara A, Mintz G, Shimshak T, Ricotta J, Ramaiah V, Foster M, Davis T, Gray W. Intravascular ultrasound evaluation of JETSTREAM atherectomy removal of superficial calcium in peripheral arteries. EuroIntervention 2015;11:96-103
5. Friedrich GJ. Am Heart J. 1994;128:435-41
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Product details
The system is an innovative peripheral revascularization platform designed to restore flow through the many types of lesion morphologies encountered in peripheral arterial disease (PAD). System consists of a single-use catheter with control pod and a reusable, compact console power source that mounts to a standard I.V. stand.
Catheter and control pod
PV Console
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Ordering information
| Product Description | UPN/Order Code | Catalog Number | GTIN | Unit | Qty |
|---|---|---|---|---|---|
| Jetstream Console | 050599-001 | PVCN100 | 08714729890430 | Each | 1 |
| Jetstream SC Atherectomy Catheter 1.85 mm | 112262-001 | PV3118F | 08714729889861 | Each | 1 |
| Jetstream SC Atherectomy Catheter 1.6 mm | 112260-001 | PV3116F | 08714789889830 | Each | 1 |
| Jetstream XC Atherectomy Catheter 2.4 mm / 3.4 mm | 112266-001 | PV41340 | 08714729889922 | Each | 1 |
| Jetstream XC Atherectomy Catheter 2.1 mm / 3.0 mm | 112264-001 | PV31300 | 08714729889892 | Each | 1 |
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Online medical training and education courses
The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Downloads
Jetstream is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. All rights reserved.
CAUTION: The law restricts these devices to sale by or on the order of a physician.