News | October 08, 2013

Biotronik Announces Completion of Enrollment in the Iliac Arm of the Bioflex-I Study

stents peripheral peripheral artery disease pad clinical trial study bioflex

October 8, 2013 — Biotronik announced it has completed patient enrollment in the iliac arm of its Bioflex-I trial. Under the supervision of Mark Burket, M.D. and chief, Cardiovascular Division at the University of Toledo Medical Center, the trial will evaluate the safety and effectiveness of the Astron and Pulsar-18 stents in the treatment of peripheral vascular disease with a view towards gaining U.S. Food and Drug Administration (FDA) approval.

The Bioflex-I trial is a prospective, non-randomized and multi-center Investigational Device Exemption (IDE) study consisting of two arms: superficial femoral artery (SFA) and iliac. Alongside ongoing enrollment in the SFA arm, the newly completed iliac arm evaluates the use of the Astron stent in the treatment of common or external iliac artery lesions. Astron is CE-marked and commercially available in over 50 countries worldwide. Astron stents were successfully implanted in 160 patients at 34 centers in the United States and Europe, completing enrollment in the iliac arm of the Bioflex-I trial.

For more information: www.clinicaltrials.gov

Related Content

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