Vascular Interventions & Therapies

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

PATHFINDER I Post-Market Registry Background

The PATHFINDER I Post-Market Registry is a prospective, non-randomized, single arm, multicenter observational study that will evaluate the performance of the Auryon Atherectomy System during standard of care procedures and measure clinical outcomes, both intermediate and long-term. Initial findings from the pilot registry study will inform and help shape a subsequent larger registry that is expected to include approximately 1,000 patients. Visit www.clinicaltrials.gov/ct2/show/NCT04229563 for more information about the PATHFINDER I Post-Market Registry.

What is PAD?

If you were diagnosed with PAD (Peripheral Artery Disease), you are suffering from narrowing or blocking of artery (“atherosclerosis”) in your leg(s). Atherosclerosis is caused by the buildup of fatty and fibrotic material within the walls of the arteries, called atherosclerotic plaques. These atherosclerotic plaques can cause narrowing of the arteries, which results in a diminished blood supply to legs and feet.

Symptoms of PAD can include:

  • Pain, aches or cramps in your buttocks, thighs, calf muscles or feet with walking or exercise which improves with rest. This is called claudication.
  • Muscle weakness or deterioration (atrophy).
  • Hair loss to the legs.
  • Smooth, shiny skin.
  • Decreased or absent pulses in legs or feet.
  • Slow-healing sores or ulcers on the legs or feet.
  • Cold or numb toes.

Risk factors for PAD Include:

  • Smoking
  • High blood pressure
  • Cardiovascular disease and/or diabetes
  • High cholesterol
  • Age above 60 years

Your physician will make treatment recommendations based on the factors including the severity of your disease and potential risk and benefits of treatment options. Treatment options may include one or more of the following:

  • Medications such as antiplatelet, cholesterol-lowering, and antihypertensive agents.
  • Exercise programs.
  • Smoking cessation.
  • Surgical revascularization.
  • Endovascular revascularization.

What is Auryon Atherectomy System?

The Auryon Atherectomy System is an FDA cleared laser technology that is used in the treatment of PAD. The Auryon System is designed to remove atherosclerotic plaques or blockages and increase blood flow without damaging the artery.


References

  • 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
  • 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.

AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. GL/ON/WP/105 Rev 01 02/20