St. Dominic's to be One of the First Hospitals in the Nation to Participate in Avinger's CONNECT II Global Clinical Trial

(March 22, 2012, Jackson, Miss.) St. Dominic's will become the first hospital in Mississippi and only the second in the country to participate in CONNECT II, a global clinical trial conditionally approved by the FDA that gives physicians access to a sophisticated new imaging technology tool, called Ocelot, to fight Peripheral Arterial Disease (PAD). Each year, nearly 200,000 amputations occur as a result of PAD and many of those can be avoided with this new technology.

The Ocelot is the first-ever 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.

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

Gray Bennett, M.D., William Crowder, M.D. and Huey McDaniel, M.D. as part of CONNECT II, will use Ocelot on enrolled patients to help restore blood flow to completely blocked arteries in patients’ legs through a simple two-millimeter skin incision, helping to avoid amputation.

"One of the most challenging techniques we face in the treatment of PAD is to cross chronically, totally occluded vessels," says Gray Bennett, M.D., Interventional Cardiologist, St. Dominic Hospital. "This device will make that technique easier for the physician and will give better patient outcomes through faster procedure times."

Huey McDaniel, Vascular Surgeon, St. Dominic Hospital said, "This innovative device gives the physician sight into the vessel where he or she could not see before. While the technique treating totally blocked arteries before the Ocelot was safe and in many cases effective, this new technology will allow a physician to treat a patient with a more severe case of PAD that would have been bound for amputation."

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.

"The patients enrolled in this trial have completely blocked leg arteries which have not been treated easily with traditional catheter procedures. Treatment would have been difficult and in some cases impossible without this new technology. This new procedure allows a minimally invasive approach to restore blood flow" said William Crowder, M.D., Interventional Cardiologist, St. Dominic Hospital. "Now patients who would have otherwise experienced the worst case scenario of amputation, may have hope for normal function in their legs."

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

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.  St. Dominic's 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 St. Dominic’s

St. Dominic’s is more than just a hospital. It is a family of services focused on fulfilling a mission of Christian healing to those in need. St. Dominic Health Services, Inc. is the parent company for a large group of subsidiary organizations and programs dedicated to the same mission. These include St. Dominic Hospital, the Community Health Services Clinic, St. Dominic Medical Associates (physician network), New Directions for Over 55, MEA Clinics, The Club at St. Dominic’s, the School Nurse Program, St. Dominic’s Foundation, St. Catherine’s Village and Care-A-Van.

St. Dominic Hospital is a 535-bed tertiary care hospital located in Jackson, MS serving all of central Mississippi and employs approximately 3,000 nurses, physicians, and skilled caregivers. The medical staff, of nearly 500 leading physicians and specialists, makes St. Dominic’s one of the most comprehensive hospitals in Mississippi. Through 65 years of growth, St. Dominic’s has remained true to its vision. We are St. Dominic’s – a Christian healing community called to provide quality, compassionate care and an Exceptional Encounter Everytime.

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.