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).

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

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
 
The JETSTREAM Calcium Study was sponsored by Bayer HealthCare.?
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