Advanced Medical Technology Treats Arterial Disease Safely & Effectively1
Kansas City, Mo., October 19, 2020 The Healient Physician Group has announced the completion of their first
atherectomy procedure by board certified interventional radiologist, David Burkart, MD, using the Auryon Atherectomy System, a newly-developed, safe1, and innovative technology that helps deliver improved outcomes for patients with Peripheral Artery Disease (PAD) and related conditions.
The Auryon Atherectomy System is the next generation of peripheral atherectomy technology: the first laser atherectomy system that efficiently treats any lesion type, any lesion length, at any lesion location, with minimal impact on vessel walls. The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is FDA cleared with an indication for treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).
The Auryon Atherectomy System’s targeted biological reactions address the risk of perforation and preserve the ability to vaporize lesions without thermal ablation. The Auryon Atherectomy System uses a 355nm wavelength laser platform which enables the use of longer wavelengths and shorter pulses2 to produce groundbreaking delivery of short UV laser pulses. The Auryon Atherectomy System is produced by AngioDynamics, Inc. For more information, please visit www.angiodynamics. com/products/66/Auryon/. For important risk information, visit www.angiodynamics.com/about- us/risk-information/.
PAD is a disease typically caused by the buildup of fatty plaque (known as atherosclerosis) in the arteries which carry blood to the extremities, although PAD is not always caused by atherosclerosis. PAD affects over 8.5 million people in the United States, and more than 200 million worldwide3. The prevalence of PAD for men and women increases with age and other factors such as high blood pressure, smoking, diabetes, and high cholesterol. Left untreated, PAD can progress to cause life- threatening conditions such as coronary artery disease and cerebrovascular disease4.
About The Healient Physician Group
The Healient Physician Group is a multi-specialty group of physicians who treat heart, vascular and wound conditions. They have been practicing for over 20 years in the Kansas City area and are located on the St. Joseph Medical Center campus. In addition to preventative care and cardiac risk assessments, they also treat Coronary Artery Disease, Peripheral Artery Disease, Cardiac Dysrhythmia, and Wound Care. To learn more visit www.healient.com .
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology.
AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.
- Rundback J, Chandra P, Brodmann M et al. Novel laser‐based catheter for peripheral atherectomy: 6‐month results from the Eximo Medical B‐Laser™ IDE study. Catheterization and Cardiovascular Interventions. 2019;94(7):1010-1017. doi:10.1002/ccd.28435
- Herzog A, Oszkinis G, Planer D, et al. Atherectomy using a solid-state laser at 355 nm wavelength. J Biophotonics. 2017;10(10):1271-1278.
- American Heart Association – PAD Resources. www.heart.org. https://www. heart.org/en/health-topics/peripheral-artery-disease/pad-resources. Published 2019. Accessed July 27, 2020.
- Peripheral Arterial Disease (PAD) | cdc.gov. Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/PAD.htm. Accessed September 3, 2020.
Important Risk Information
Caution: Federal (USA) law restricts the use of the system by or on the order of a physician.
INDICATION FOR USE: The AURYON Atherectomy System is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).
CONTRAINDICATIONS: The use of AURYON Atherectomy System is contraindicated where patients are contraindicated for intravascular
rating is marked on the back panel of the laser controller. Operating the system at the incorrect voltage may result in damage to the system units.
- The system is not intended to be used during a defibrillation event.
- Skin exposure to laser radiation should be avoided.
- Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases. The laser beam may ignite solvents of adhesives and flammable solutions. Allow
intervention for PAD.
- The AURYON Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. Improper use of the AURYON
Atherectomy System could result in serious personal injury. Observe all safety precautions for use of Class IV laser equipment.
- The AURYON Atherectomy System contains high voltages which are
potentially lethal. To avoid electrical shock, do not open the AURYON Atherectomy System cover. Internal maintenance of the system must be performed only by personnel from AngioDynamics.
- Ensure the system is connected to the proper voltage. The voltage
flammable materials to evaporate before the laser is used.
- Only catheters approved by AngioDynamics are allowed to be used in the AURYON Atherectomy System. AngioDynamics supplies sterile fiber optic catheters. Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date.
- Pay attention when handling the AURYON OTW catheter to ensure
that the fibers at the distal and proximal ends are not damaged.
- When moving the AURYON Atherectomy System be careful to avoid crashing or sudden impacts. Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor.
USA > 14 Plaza Drive, Latham, NY 12110 > tel: 800-772-6446 or 518-798-1215 > fax: 518-798-1360
International > Haaksbergweg 75 (Margriettoren), 1101 BR, Amsterdam Z-O > The Netherlands www.angiodynamics.com | Auryon-PAD.com
AngioDynamics, the AngioDynamics logo, Auryon, and the Auryon logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. GL/PA/MS/312 Rev 01 09/2020