AtheroMed 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 Craig Walker, an interventional cardiologist and Medical Director of the Cardiovascular Institute of the South in Houma, Louisiana. “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” 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 Atherectomy 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.