Trial results for a post-market registry investigating the AURYON Atherectomy System in patients with Infrainguinal Peripheral Artery Disease were posted on ClinicalTrials.gov on 2026-05-18, reporting that 97 participants were free from peri-procedural major adverse events.
Background
Peripheral Artery Disease (PAD), particularly in the infrainguinal region, is a common circulatory problem where narrowed arteries reduce blood flow to the limbs. This can cause leg pain when walking (claudication), non-healing wounds, and in severe cases, critical limb ischemia, potentially leading to amputation. Atherectomy is a minimally invasive procedure used to remove plaque from arteries, aiming to restore blood flow and alleviate symptoms. Post-market registries like PATHFINDER are crucial for evaluating the real-world performance and safety of new or recently launched devices, such as the AURYON Atherectomy System, in a broader patient population beyond initial clinical trials.
Trial design
The PATHFINDER Registry (NCT04229563) was a completed prospective, non-randomized, single-arm, multicenter observational study that enrolled 102 participants. The study focused on patients diagnosed with Infrainguinal Peripheral Artery Disease and Peripheral Arterial Disease (PAD). Its primary objective was to evaluate the performance and clinical outcomes of the AURYON Atherectomy System during its initial market launch phase. Key outcomes assessed included acute procedural success and freedom from peri-procedural major adverse events.
Key results
The registry reported several key measurements regarding the performance and safety of the AURYON Atherectomy System:
- For primary efficacy, acute procedural success was observed in 69 Lesions.
- For primary safety, freedom from peri-procedural Major Adverse Events (PPMAE) was achieved in 97 Participants.
- The number of participants with device-related complications requiring intervention was 5 Participants.
- Major Adverse Events (MAEs) over time were reported as:
- 3 Participants at 30 Days
- 9 Participants at 6 Months
- 10 Participants at 12 Months
- 13 Participants at 24 Months
- The number of patent lesions was reported as:
- 49 Lesions at 6 Months
- 48 Lesions at 12 Months
- 37 Lesions at 24 Months
- Freedom from occlusion was observed in:
- 17 Lesions at 6 Months
- 15 Lesions at 12 Months
What this means
The results from the PATHFINDER Registry provide insights into the real-world performance of the AURYON Atherectomy System for patients with infrainguinal peripheral artery disease. The high rate of freedom from peri-procedural major adverse events, reported in 97 out of 102 participants, suggests a favorable acute safety profile for the device. Acute procedural success in 69 lesions indicates the device's effectiveness in achieving its immediate therapeutic goal. While major adverse events increased over time, reaching 13 participants at 24 months, and patency rates decreased, these long-term outcomes are typical considerations in PAD management. The data offers clinicians valuable information on both the immediate safety and the intermediate-term outcomes associated with the AURYON Atherectomy System in a post-market setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04229563, titled "Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease", were posted on 2026-05-18 on clinicaltrials.gov.