News | June 08, 2012

Austin Heart Enrolls PAD Patients in Avinger’s CONNECT II Global Clinical Trial

Interventional Cardiologists Conduct Patient Cases to Help Decrease Unnecessary Amputations

June 8, 2012 — Austin Heart, the largest provider of cardiac and vascular services in central Texas, announced its participation in CONNECT II, a global clinical trial conditionally approved by the U.S. Food and Drug Administration (FDA) that gives physicians access to a new imaging technology tool to fight peripheral arterial disease (PAD). The technology, called Ocelot, helps to eliminate the need for bypass surgeries and/or amputations in patients with the disease. Each year, nearly 200,000 amputations occur as a result of PAD.

The Ocelot system uses forward-looking intravascular optical coherence tomography (OCT) to visualize where the tip of the catheter is going. This enables it to cross chronic total occlusions (CTOs) that typically block arteries in PAD and restore blood flow.

Matthew Selmon, Roger Gammon, Marc Picone and Frank Zidar are the interventional cardiologists at Austin Heart participating in the CONNECT II trial. During the procedures, Austin Heart doctors will use Ocelot to help restore blood flow in completely blocked arteries in patients’ legs through a simple 2 mm skin incision, helping to avoid amputation.

PAD, affecting between 8 and 12 million adults in the United States alone, is caused by a build-up of plaque in the arteries that blocks blood flow to the legs and feet. Because some blockages can become so severe and difficult to penetrate with traditional catheters, patients unaware of other options often resort to undergo extremely invasive bypass surgeries that result in even higher health risks and lengthy, painful recoveries. Patients over 50 often face amputation, the worst-case scenario associated with PAD.

“Avinger’s John B. Simpson has invented a technology that enables Austin Heart’s team of interventional cardiologists to treat PAD patients with more precision than ever before possible,” said Selmon, national principle investigator. “The trial is hoping to help patients regain mobility and improve quality of life, and in the process many patients might be spared unnecessary amputations. Austin Heart is committed to saving the legs of our PAD patients so they can return to a healthy life.”

Ocelot is the first CTO-crossing catheter that can access exact regions of the peripheral vasculature where the blockages occur, while simultaneously providing physicians with visualization for real-time navigation during an intervention.

CONNECT II trial procedures using Ocelot are minimally invasive and designed to allow patients to leave the hospital within hours, and return to normal activities within a few days.

For more information: www.avinger.com

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