Jetstream™

Atherectomy System

The Multicenter Pathway PVD Trial1

Objective

To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions.

Lesion Location

SFA ​134/210 (64%)​
Popliteal artery ​58/210 (28%)​
Tibial artery
(including TPT) ​		18/210 (9%)​
Lesion length, mm ​27.4±23.9 (3.0–100.0) 95% CI 24.2 to 30.7​
SFA (n5134) ​29.9±26.2 (5.0–100.0) 95% CI 25.4 to 34.4​
Anterior tibial (n52) ​22.5±10.6 (15.0–30.0) 95% CI 272.8 to 117.8​
TPT (n513) ​13.9±8.9 (3.0–30.0) 95% CI 8.5 to 19.3​
Posterior tibial (n51) ​15.0​
Popliteal (n557*) ​25.8±19.8 (3.0–100.0) 95% CI 20.5 to 31.0​
Peroneal (n52) ​10.0±0.0 (10.0–10.0)​
Moderate to high calcium ​108/210 (51%)​
Total occlusions ​64/208 (31%)​
Reference vessel diameter, mm ​4.5±0.6 (3.0–6.0) 95% CI 4.4 to 4.6​
SFA (n5134) ​4.6±0.5 (3.5–5.5) 95% CI 4.6 to 4.7​
Anterior tibial (n52) ​3.0±0.0 (3.0–3.0)​
TPT (n513) ​3.7±0.8 (3.0–5.0) 95% CI 3.2 to 4.2​
Posterior tibial (n51) ​3.0​
Popliteal (n558) ​4.5±0.6 (3.5–6.0) 95% CI 4.3 to 4.6​
Peroneal (n52) ​3.0±0.0 (3.0–3.0)

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Key Clinical Results​

  • Device success was 99% (208/210 lesions)​
  • MAE at 30 days was 1% (2 preplanned amputations)​
  • Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively​
  • The 1-year restenosis rate was 38.2% based on duplex imaging​
  • The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p<0.05) at 12 months. ​
  • Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p<0.05).​

Total occlusion of a right superficial femoral artery at (A) baseline, (B) after atherectomy, (C) after adjunctive 5-mm balloon angioplasty, and (D) 30 months post procedure. ​

 

1.  Zeller T et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: themulticenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62.
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