Jetstream™

Atherectomy System

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.

Key Resources

Indications, Safety and Warnings

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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

Number of Passes (average*)

• 2.0 blades down
• 1.8 blades up

Embolic Protection

• 22.4% of cases

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%.

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