AHH Blog

Arkansas Heart Hospital Enrolls First U.S. PAD Patient In CONNECT II Global Clinical Trial

Mar 07, 2012

Contact: Rachelle Lamphere
Director of Marketing
Arkansas Heart Hospital

Landmark treatment successful in first U.S. patient

Little Rock, AR March 6, 2012— Arkansas Heart Hospital announces its participation in CONNECT II, a global clinical trial conditionally approved by the FDA that gives physicians access to a sophisticated 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 and many of them can be avoided.

PAD, affecting between 8 and 12 million adults in the U.S. 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.

Ian Cawich, M.D., Interventional Cardiologist and David Mego, M.D., Interventional Cardiologist and Director of Interventional Cardiology at Arkansas Heart Hospital, as part of CONNECT II, will use Ocelot on enrolled patients to help restore blood flow in completely blocked arteries in patients’ legs through a simple two-millimeter skin incision, helping to avoid amputation.  They are also leading other co-investigators at Arkansas Heart Hospital.

“This technology is a big leap forward, combining inside the artery imaging and tools to deal with the blockage. For the first time, we’ve been able to combine imaging inside the artery while treating the vessel at the same time,” said Dr. Bruce Murphy, M.D., PhD, President and CEO of Arkansas Heart Hospital. “That advanced technology enables the cardiologist to visualize their progress in real time. The imaging technology is on the catheter, which is inserted into the patient.”

Ocelot is the first-ever 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 will permit patients to leave the hospital within hours of the minimally invasive procedure and return to normal activities within a few days.

More about CONNECT II and Ocelot

CONNECT II is a prospective, multi-center, non-randomized global clinical study that will evaluate Ocelot on 100 PAD patients with femoropopliteal CTO lesions at 17 sites, including three in the EU, where Ocelot received CE Mark in 2011. To learn more about CONNECT II and the first global patients enrolled, visit: http://avinger.com/newsroom.

More about PAD, Importance of Early Detection

Often dismissed as normal signs of aging, symptoms of PAD include painful cramping, numbness, or discoloration in the legs or feet. Hospitalization costs of PAD alone are estimated to exceed $21 billion annually, largely due to late detection and patients experiencing a decreased quality of life from invasive bypass surgery and/or amputation. 

Arkansas Heart Hospital encourages those that are experiencing any of the above symptoms to ask their doctor about their risks for PAD, as early detection is the key to saving limbs.

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 received CE Mark in 2011 to market Ocelot, the first ever real-time OCT crossing catheter. www.avinger.com.