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
- Non-invasive arterial pressure measurements in the legs including an Ankle-Brachial Index (ABI) or Toe-Brachial Indices (TBI).
- Arterial Doppler and vascular ultrasound.
- Imaging including Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA).
- 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:
- Pain, aches or cramps in legs with walking or exercise, which improves with rest. This is called claudication.
- Muscle weakness or deterioration (atrophy).
- Hair loss on the legs.
- Smooth, shiny skin.
- Decreased or absent pulse in legs or feet.
- Slow-healing sores or ulcers on legs or feet.
- 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:
- Medications such as antiplatelet, cholesterol lowering, and antihypertensive agents.
- Exercise programs.
- Smoking cessation.
- Surgical revascularization.
- 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 email@example.com
- 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.