97 patients. 107 lesions. No problem.

The Auryon System demonstrated clinically proven performance in a broad range of disease severity.

Individual results may vary.

Efficacy

A multinational pivotal trial* involved 97 symptomatic (Rutherford 2-4) patients with peripheral artery disease (PAD) (107 lesions) from both office-based labs and hospitals.1,2

PATIENT AND LESION CHARACTERISTICS1
74% femoral, 8% popliteal, and 18% tibial
22% occluded
21% restenotic
86% stenotic
77% Had calcification
(38% had moderate to severe calcium)
Studied in a real-word patient population
Population included patients with comorbidities, including 42% with diabetes.1,2
KEY 6-MONTH CLINICAL EFFICACY RESULTS1,2*
31% TO 38% Reduction in stenosis prior to any adjunctive therapy regardless of calcification level, lesion type, lesion length, or catheter used†
Final stenosis after percutaneous transluminal angioplasty (PTA) 17.7%
3% Of lesions had clinically driven target lesion revascularizations (CD-TLRs)
0 were in-stent restenosis (ISR)
93% Of patients showed improvement in Rutherford
2-point average improvement
Consistency despite calcification
Improvements in stenosis and patency were consistent across all levels of calcification and types of lesions.1,2

*Study design: EX-PAD-03 (clinicaltrials.gov identifier: NCT03157531) was a pivotal study under investigational device exemption from the FDA. EX-PAD-03 was a prospective, single-arm, international, multicenter, open-label clinical study that assessed the safety and efficacy of the Auryon System in subjects with symptomatic (Rutherford 2-4) infrainguinal PAD at 8 US and 3 EU sites.

† Segments analyzed by Core Lab and included calcification level: none, mild, moderate, severe; lesion type: general, ISR, chronic.

Comparable reduction in stenosis regardless of calcification level1

Bar graph showing the comparable reduction in stenosis regardless of calcification levelVertical grey bar that is part of the bar graphVertical blue bar that is part of the bar graphVertical grey bar that is part of the bar graphVertical blue bar that is part of the bar graphVertical grey bar that is part of the bar graphVertical blue bar that is part of the bar graphVertical grey bar that is part of the bar graphVertical blue bar that is part of the bar graphContent of bar graph explaining the reduction in stenosis regardless of calcification level
Key of bar graph showing baseline and post Auryon
Grey and blue bars that are part of the bar graph
Comparable reduction mild
Grey and blue bars that are part of the bar graph
Grey and blue bars that are part of the bar graph
33.3% average reduction across all levels of calcification

Low incidence of adverse events 6 months post procedure1

A multinational pivotal trial* involved 97 symptomatic (Rutherford 2-4) patients with peripheral artery disease (PAD) (107 lesions) from both office-based labs and hospitals.1,2

The Auryon System catheters for peripheral atherectomy in PAD treatment

Key 6-month safety results (107 lesions)1

  • 0%

    Flow-limiting dissections

  • 0%

    Device-related complications requiring intervention

  • 0%

    Distal embolizations

  • 3%

    CD-TLRs; none were ISR

  • 1%

    Major adverse event (non-device-related death)

See real-world examples of the Auryon System in action

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References: 1. Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study. Catheter Cardiovasc Interv. 2019;1-8. 2. Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-Laser™, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92.