AtheroMed Begins EASE Trial of Phoenix Atherectomy Catheter

September 2, 2010—AtheroMed, Inc. (Menlo Park, CA) announced the start of enrollment in the EASE (Endovascular Atherectomy Safety and Effectiveness) study to evaluate the safety and effectiveness of the Phoenix atherectomy catheter for treating peripheral arterial disease. The EASE clinical trial is approved by the US Food and Drug Administration under an investigational device exemption and will enroll 90 patients at up to 20 clinical sites. The device is limited to investigational use only in the United States and has received CE Mark approval in Europe.


Craig Walker, MD, who treated the first patient in the trial, commented, “The Phoenix atherectomy 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.”

According to the company, the Phoenix atherectomy catheter is designed to cut, capture, and convey arterial plaque into an external bag visible to the physician. The front-cutting catheter has a deflectable tip engineered to treat a range of blood vessel sizes with a single insertion of one single-use device.

EASE Principal Investigator Tom Davis, MD, commented, “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.”