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Jetstream™

Atherectomy System

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).

Key Resources

Indications, Safety and Warnings
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Study Design

Jetstream Calcium Study - Design
 

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 

Journal Articles

Download Key Learnings from the Calcium Study
Key Learnings from the Calcium Study

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Details

56% diabetic patients; 0 distal protection utilized

Results

Lumen area increased from 6.6mm2 pre-IVUS to 10mm2 post-IVUS; P=0.001
Study Results show 86% of lumen gain was directly attributed to calcium reduction
0 major adverse events at 30 days

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.

Jetstream Calcium Study: Image 1a (Angio): Pre-procedure CTO of right distal SFA/proximal popliteal
Pre-procedure CTO of right distal SFA/proximal popliteal
Jetstream Calcium Study: Image 1b (Angio): Final angiogram: post-Jetstream atherectomy and adjunctive PTA
Final angiogram: post-Jetstream atherectomy and adjunctive PTA
Jetstream Calcium Study: Image 2a (IVUS):Pre-procedure CTO of right distal SFA/proximal popliteal. Baseline IVUS measurement reveals area of 2.5 mm2
Pre-procedure CTO of right distal SFA/proximal popliteal. Baseline IVUS measurement reveals area of 2.5 mm2
Jetstream Calcium Study: Image 2b (IVUS): Standalone Jetstream result (prior to PTA) reveals an IVUS measurement of 7.6 mm<sup>2</sup>
Standalone Jetstream result (prior to PTA) reveals an IVUS measurement of 7.6 mm2
 
View Calcium Study IVUS Case Library
The JETSTREAM Calcium Study was sponsored by Bayer HealthCare.​
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