News | October 22, 2013

EASE Study Successful for Phoenix Atherectomy System in Treating PAD

Study assessed safety and effectiveness of Phoenix System

October 22, 2013 — AtheroMed, a developer of catheter technologies for treating peripheral artery disease (PAD), announced results from its Endovascular Atherectomy Safety and Effectiveness (EASE) study during a late-breaking clinical trials session at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas. Stephen Williams, M.D., director of the Vascular Medicine Center, Johns Hopkins University, presented the results of the study, which demonstrate the safety and effectiveness of the Phoenix atherectomy system in treating PAD.

EASE is a prospective, multicenter, single-arm study of 105 patients (123 lesions) in the United States and Germany that evaluated the Phoenix atherectomy system in the treatment of lesions in the lower extremity arteries. The Phoenix system is an atherectomy device that uses a front-cutting, low profile design to continuously cut, capture and clear atheroma from the patient without requiring specialized capital equipment. Co-principal investigators of the study are Thomas Davis, St. John Hospital, and James McKinsey, Columbia Presbyterian Hospital.

The results presented by Williams highlight that the Phoenix system achieved its pre-defined performance goals to demonstrate safety and effectiveness: 95.1 percent of the lesions treated achieved technical success, and, at 30 days, 94.3 percent of patients were free from major adverse events. Flow-limiting dissections (Grade C or D) were observed in 1.9 percent of lesions with bail-out stenting required in 0.95 percent of lesions. Intervention due to distal embolization was limited to 0.95 percent of lesions.

"The results from the EASE study are very encouraging and are consistent with pivotal trials for other atherectomy devices," said Williams. "With more than 70 percent of the patients in the study suffering from blockages at or below the knee, the Phoenix system is likely to be a promising treatment alternative for these challenging procedures."

"I was pleased to see the positive results of the EASE data released at VIVA," said Thomas Zeller, head of the department of angiology, Herzzentrum University in Bad Krozingen, Germany. "These results are in line with my own experience with the Phoenix catheter, and I look forward to it being made available to my patients in the near future."

For more information:

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Clinical Study | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init