LITTLE ROCK, Ark. & REDWOOD CITY, Calif.–(BUSINESS WIRE)–Avinger, Inc., a medical device manufacturer of innovative,
multi-functional catheters for treating patients with Peripheral Artery Disease
(PAD), announces the enrollment of the first U.S. patient in the CONNECT II
global clinical trial. Dr. Ian Cawich of Arkansas
Heart Hospital
enrolled the first U.S.
patient this morning. This announcement comes just two weeks after Dr. Bernhard
Reimers enrolled the first European patient in the CONNECT II trial at Ospedale
di Mirano in Mirano, Italy.
CONNECT II is a multi-center, non-randomized global clinical
study designed to evaluate the safety and efficacy of Ocelot, the first-ever CTO
crossing catheter to use real-time intravascular imaging technology called
Optical Coherence Tomography, or 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 navigate inside the arteries.
“We hope that physicians using Ocelot can now help prevent
even more leg amputations in people suffering from PAD,” said Avingers founder
and CEO John B. Simpson, PhD, MD. “The team here at Avinger has been working
really hard and Im excited to see our efforts now go directly towards helping
these patients.”
The Ocelot catheter uses OCT technology as a navigation tool
with the goal of traversing CTOs more safely and effectively as part of a
procedure to restore blood flow back to normal in the legs. It allows
physicians, in real time, to see whats happening inside the arteries during
the actual intervention, giving patients a better chance to receive the best
treatment possible during a single hospital visit.
“We are participating in CONNECT II because our patient, if
treated with other current options on the medical market, could face amputation
and death,” said Dr. Ian Cawich at the Arkansas Heart
Hospital. “With Avingers
Ocelot, we believe this patient can be saved right now from both. The timing of
this trial feels like a bit of miracle to our patient.”
More about CONNECT II Clinical Trial
CONNECT II is a prospective, multi-center, non-randomized global clinical study
that will evaluate 100 PAD patients with femoropopliteal CTO lesions at 17
sites, including three in the EU, where Ocelot received CE Mark in 2011.
As part of the trial, an independent group of physicians
will review the angiography results to determine Ocelots crossing efficacy and
safety.
Conditional FDA approval to conduct this study was received
on January 27, 2012. Co-principal investigators for the trial include Arne
Schwindt, MD of St. Franziskus Hospital in Muenster,
Germany, and Matthew Selmon,
MD, Austin Heart
Hospital in Austin, TX.
Avingers global product portfolio has already helped
physicians treat more than 7,900 patients suffering from PAD. Major causes of
PAD include smoking, obesity, high cholesterol, high blood pressure, diabetes,
inactivity, and poor diet. It is estimated that PAD currently affects between 8
and 12 million adults in the United
States and is the leading cause of
amputation in patients over 50.
About Avinger
Founded in 2007 by renowned cardiologist and medical device entrepreneur Dr.
John B. Simpson, Avinger develops next-generation catheter-based technologies
for the treatment of peripheral artery disease (PAD). Leveraging core
competencies in medical device catheter engineering and intravascular Optical
Coherence Tomography (OCT), Avinger markets Wildcat and Kittycat catheters, and
recently received CE Mark to market Ocelot, the first ever real-time OCT crossing catheter. www.avinger.com
