Jetstream™

Atherectomy System

Jetstream Calcium Study1​

Objective

To better understand the mechanism of lumen gain in calcified lesions when using the Jetstream Atherectomy System.

Lesion Characteristics

Lesion location

Superficial femoral artery​ 76%​
Popliteal artery​ 33%​
Common femoral artery​  5%​
Superficial and popliteal artery​ 10%​
Common and superficial femoral artery​  5%​
De novo lesion​ 90.5%​
Operator visual assessment Calcium grading​

Moderate​

33.3%​

Severe​

66.7%​

Lesion length (mm)​

55 [20, 120]​

Lesion diameter (mm)​

5.0 [4.3, 6.0]​

Diameter stenosis​

Pre-treatment (%)​

82 [80, 90]​

Post-atherectomy(%)​

40 [30, 40]​

Diameter stenosis
Pre-treatment (%)​ 82 [80, 90]​
Post-atherectomy(%)​ 40 [30, 40]

Key Clinical Results​

  • Minimum lumen area increased from 4.3 [3.0, 5.5] mm2 to 7.4 [6.6, 10.3] mm2 (p<0.0001)​
  • Lumen symmetry (minimum/maximum lumen diameter) increased from 0.70 [0.60, 0.78] to 0.79 [0.73, 0.87] (p=0.02) after treatment​
  • Calcium reduction resulted in a 78% [70, 86] increase in lumen area​
  • A convex shape of the superficial calcium was seen in 67% of cases before treatment and in 26% after treatment (p=0.0004)​
  • Although the arc of superficial calcium did not change, the arc of reverberation increased significantly​

1.  Pre-Intervention

Lumen Area = 5.2mm2

 

2.  Post-JETSTREAM

Lumen Area = 6.9mm2

 

3.  Post-Balloon

Lumen Area = 15.2mm2

 


1.  http://www.eventscribe.com/2013/isetcio/PostersTitles.asp?h=Browse by Title “JETSTREAM Atherectomy System Can Remove Superficial Calcium in Severely Calcified Peripheral Arteries” ​


The JETSTREAM Calcium Study was sponsored by Bayer HealthCare.​

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