Receive our newsletter – data, insights and analysis delivered to you
March 6, 2012

Avinger enrols first US patient in CONNECT II trial

Avinger, a medical device manufacturer of multifunctional catheters, has enrolled the first US patient with peripheral artery disease (PAD) for the CONNECT II global clinical trial conducted at the Arkansas Heart Hospital, US.

By admin-demo

Avinger, a medical device manufacturer of multifunctional catheters, has enrolled the first US patient with peripheral artery disease (PAD) for the CONNECT II global clinical trial conducted at the Arkansas Heart Hospital, US.

Connect II is a multicentre non-randomised global clinical study that will evaluate 100 PAD patients with femoropopliteal chronic total occlusion (CTO) lesions for the safety and efficacy of Ocelot, a CTO crossing catheter.

CE marked, Ocelot is designed for crossing completely blocked arteries in the legs while simultaneously using optical coherence tomography (OCT) to visualise inside the arteries.

The Ocelot employs real-time OCT imaging as a navigation tool to traverse completely blocked arteries precisely where needed, in order to restore blood flow back to normal in the legs. As part of the trial, an independent group of physicians will review the angiography results to determine Ocelot’s crossing efficacy and safety, the company said. Ocelot allows physicians to observe what’s happening inside the arteries during the actual intervention, providing patients with a chance to receive the best treatment possible during a single hospital visit.

Avinger founder and CEO John Simpson said they believe physicians using Ocelot can now help prevent leg amputations in people suffering from PAD. In January 2012, the company received conditional US Food and Drug Administration (FDA) approval to conduct the study.

Co-principal investigators for the trial include Arne Schwindt of St. Franziskus Hospital in Muenster, Germany, and Matthew Selmon of the Austin Heart Hospital in Austin, Texas, US.

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

Avinger develops next-generation catheter-based technologies for the treatment of PAD.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU