AtheroMed Announces FDA Clearance

ATHEROMED ANNOUNCES FDA CLEARANCE TO MARKET THE PHOENIX ATHERECTOMY SYSTEM® FOR TREATING PERIPHERAL ARTERY DISEASE

MENLO PARK, CA – January 27, 2014 – AtheroMed, a developer of innovative catheter technologies for treating peripheral artery disease (PAD), today announced that it has received FDA clearance to market the Phoenix Atherectomy System®, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.
“Peripheral artery disease, especially lesions located below the knee, can be challenging to treat, even with currently available technologies,” said Dr. Thomas Davis, Director of the Cardiac Catheterization Lab and Director of Peripheral Interventions and Disease at St. John Hospital and Medical Center in Detroit, MI. “My experience with the Phoenix device during the EASE clinical study was extremely positive, and I am excited that the device is now available as it will allow me to debulk small vessels that I may not have been able to treat in the past.”
The Phoenix Atherectomy System is a peripheral atherectomy system that has been designed to provide physicians with a safe, versatile, easy to use, primary therapy for treating PAD to restore blood flow to the ankle and foot. The over-the wire system uses a rotating, front-cutting element located at the distal tip of the catheter to shave material directly into the catheter. The debulked material is then continuously captured and removed by an internal Archimedes Screw running the length of the catheter. The Phoenix Atherectomy System is available in multiple sizes to treat diseased vessels from the thigh to the foot with catheter sizes down to 1.8mm in diameter with a 5F profile.
“FDA clearance to market the Phoenix Atherectomy System marks a significant milestone for our company and allows us to begin improving the lives of patients suffering from PAD,” said Mike MacKinnon, President and CEO of AtheroMed. “The Phoenix Atherectomy System combines a low profile, flexible catheter shaft design with a mechanism of action that continuously clears debris from the body, so physicians can now safely perform atherectomy in vessels that previously may have been out of their reach. We are excited to now bring this treatment option to physicians and their patients.”
About AtheroMed
AtheroMed, Inc., a privately-held medical device company based in Menlo Park, California, is dedicated to developing innovative technology for treating peripheral artery disease to quickly, safely, and effectively restore blood flow and improve the lives of the 18 million Americans suffering with PAD and save the limbs of the 3.5 million Americans with Critical Limb Ischemia (CLI), the most severe form of PAD.
For more information please visit www.atheromedinc.com.
MEDIA CONTACT:
Will Martin
VP, Commercial Operations
(770) 639-2777
wmartin@atheromedinc.com

©2014 AtheroMed®, Inc.  The Phoenix Atherectomy System® is FDA 510(k) cleared for use in United States.  CAUTION:  Federal (US) law restricts this device to sale by or on the order of a physician. The Phoenix Atherectomy System® is also CE marked for international use. INDICATIONS: The Phoenix Atherectomy System® is intended for use in atherectomy of the peripheral vasculature. The System is not intended for use in the coronary, carotid, iliac or renal vasculature.