Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory

Number of lesions assessed by the angiographic core lab

MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).

Technical Procedural Success was defined as meeting all of the following requirements:

• Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory
• No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)
• No device malfunction causing the procedure to be aborted
• Successful delivery and placement of the SpiderFX™ embolic protection device

Total patient population minus one patient because there was no angiographic post-treatment core lab data available.

This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.

1 lesion not included because there is no angiographic core laboratory post-treatment data available

Presence of debris in deployed SpiderFx™ embolic protection device

Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.

115/133 subjects had the required angiographic images to assess this outcome.