News | February 27, 2012

First European PAD Patient Enrolled in Forward-Looking OCT Trial

Avinger Inc. announced the enrollment of the first European patient in the CONNECT II global clinical trial. The first patient was enrolled by Dr. Bernhard Reimers at Ospedale di Mirano in Mirano, Italy.

CONNECT II is a multicenter, nonrandomized global clinical study designed to evaluate the safety and efficacy of Ocelot, Avinger’s first therapeutic catheter to incorporate the real-time intravascular imaging technology called optical coherence tomography (OCT). Currently CE-marked, Ocelot is designed for crossing completely blocked arteries, or chronic total occlusions (CTOs), in the legs while simultaneously using OCT to visualize inside the arteries. Ocelot is the first CTO-crossing catheter to incorporate OCT.

“Ocelot and CONNECT II is our first step toward incorporating intravascular imaging into therapeutic catheters. We truly believe this will revolutionize the treatment of vascular disease and amputation prevention,” said Avinger founder and CEO John B. Simpson.

As part of the trial, an independent group of physicians will review the angiography results to determine crossing efficacy and safety. Conditional U.S. Food and Drug Administration (FDA) approval to conduct the study was received Jan. 27, 2012. Co-principal investigators for the trial include Arne Schwindt of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon, M,D,, Austin Heart Hospital in Austin, Texas.

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