AtheroMed has started 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.
AtheroMed said that the 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 Phoenix Atherectomy catheter is designed to cut, capture and convey arterial plaque into an external bag visible to the physician and has a deflectable tip engineered to treat a range of blood vessel sizes with a single insertion of one, single-use device.
AtheroMed president and CEO Will McGuire said that the Phoenix Atherectomy catheter has been developed to provide physicians with a safe, versatile, easy to use alternative for treating PAD in the legs and he was pleased to begin enrollment in the EASE study and appreciate the support provided by Dr. Walker and his team in initiating this clinical trial.
EASE study principal investigator Tom Davis said that they are excited to enroll the first patient in the EASE study to evaluate this promising new atherectomy technology.
“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,” Davis said.