Vascular Interventions & Therapies

Post-Market Registry of Auryon™ Atherectomy System in Subjects Affected with Infrainguinal Peripheral Artery Disease

What is the PATHFINDER I Post-Market Registry?

The PATHFINDER I Post-Market Registry is a multicenter, prospective, observational registry that will collect data on patients with symptomatic Peripheral Artery Disease (PAD) who undergo atherectomy with the Auryon Atherectomy System.

  • PAD can be diagnosed based on the patient’s history and physical examination and testing which can include
    1. Non-invasive arterial pressure measurements in the legs including an Ankle-Brachial Index (ABI) or Toe-Brachial Indices (TBI).
    2. Arterial Doppler and vascular ultrasound.
    3. Imaging including Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA).
    4. Diagnostic percutaneous lower extremity angiography, a procedure where dye is injected in the arteries in the legs to assess for arterial disease under fluoroscopy (x-ray).
  • Increase in Incidence Rate - Approximately 8.5 million people age 40 and older in the United States have PAD.
  • Symptoms of PAD:
    1. Pain, aches or cramps in legs with walking or exercise, which improves with rest. This is called claudication.
    2. Muscle weakness or deterioration (atrophy).
    3. Hair loss on the legs.
    4. Smooth, shiny skin.
    5. Decreased or absent pulse in legs or feet.
    6. Slow-healing sores or ulcers on legs or feet.
    7. Cold or numb toes.
  • PAD Risk Factors: smoking, high blood pressure, atherosclerosis, diabetes, high cholesterol and age above 60 years.
  • Your physician will make treatment recommendations based on the factors including the severity of disease, risk and benefits. Current therapies include:
    1. Medications such as antiplatelet, cholesterol lowering, and antihypertensive agents.
    2. Exercise programs.
    3. Smoking cessation.
    4. Surgical revascularization.
    5. Endovascular revascularization.

How to Learn more?

If you would like to learn more about the PATHFINDER I Post-Market Registry, including information on active hospital sites that are enrolling and patient qualifying information, please email our study support address at pathfinder@angiodynamics.com

References:

  • Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation. 2019;139(10):e56–528.
  • Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published correction appears in J Am Coll Cardiol. 2017 Mar 21;69(11):1521]. J Am Coll Cardiol. 2017;69(11):e71-e126. doi:10.1016/j.jacc.2016.11.007
  • Rooke TW, Wennberg PW. Diagnosis and management of diseases of the peripheral arteries and veins. In: Fuster V, O’Rourke RA, Walsh RA, Poole-Wilson P, eds. Hurst’s The Heart. 12th ed. New York, NY: McGraw-Hill; 2007.
  • Peripheral Arterial Disease. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/PAD.htm#:~:text=If%20you%20have%20PAD%2C%20you,a%20heart%20attack%20or%20stroke.&text=The%20image%20on%20the%20left,courtesy%20of%20Michigan%20Medical%20Report%20. Published December 9, 2019. Accessed July 30, 2020.

GENERAL NOTE: B-Laser was the initial name of the device. In 2020, the name “B-Laser” was replaced by the Auryon Atherectomy System. Both names (B-Laser and the Auryon Atherectomy System, also referred to simply as “Auryon”) refer to the same device. All references for B-Laser on this website, supporting documents including publications and on the device labeling for this study, refer to the Auryon Atherectomy System.

AngioDynamics, Auryon, and B-Laser are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.