AtheroMed, Inc. Launches EASE Clinical Trial to Evaluate PAD Treatment
Phoenix Atherectomy(tm) Catheter Treats Atherosclerotic Disease in the Legs
MENLO PARK, Calif. - AtheroMed, Inc. announced the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy™ catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs. EASE — Endovascular Atherectomy Safety and Effectiveness — is an FDA-approved Investigational Device Exemption (IDE) clinical trial that will enroll 90 patients at up to 20 clinical sites.
The first patient was treated by Dr. Craig Walker, an interventional cardiologist and Medical Director of the Cardiovascular Institute of the South in Houma, Louisiana. "The Phoenix Atherectomy(tm) device created a large, smooth channel in a totally occluded anterior tibial artery with no evidence of distal debris. The device was easy to prep and quite easy to use. I am optimistic that this will be a useful tool in the treatment of atherosclerotic disease" commented Dr. Walker.
The Phoenix Atherectomy catheter is designed to cut, capture and convey arterial plaque into an external bag visible to the physician. The catheter is front-cutting and has a unique deflectable tip engineered to treat a range of blood vessel sizes with a single insertion of one, single-use device. "The Phoenix AtherectomyÔ catheter has been developed to provide physicians with a safe, versatile, easy to use alternative for treating PAD in the legs" said Will McGuire, President and CEO of AtheroMed, Inc. "I am pleased to begin enrollment in the EASE study and appreciate the support provided by Dr. Walker and his team in initiating this clinical trial."
"We are excited to enroll the first patient in the EASE study to evaluate this promising new atherectomy technology," said Dr. Tom Davis, interventional cardiologist and Director of Peripheral Interventions and Disease at St. John's Hospital in Detroit, Michigan and the Principal Investigator for the EASE study. "I am enthusiastic about the potential for the Phoenix catheter to treat a wider range of arteries and disease with a single catheter. This technology could play a very impactful role in treating limb salvage patients and reducing leg amputations."
About AtheroMed, Inc.
Founded in 2006 and headquartered in Menlo Park, California, AtheroMed, Inc. is a private company focused on advancing the treatment of PAD. AtheroMed's first product in development is the proprietary, minimally invasive Phoenix AtherectomyÔ catheter.
In the U.S., the Phoenix Atherectomy catheter is an investigational device limited by applicable law to investigational use only and is not available for sale. The Phoenix AtherectomyÔ catheter has a CE mark.
Source: AtheroMed, Inc. www.atheromedinc.com
