AUSTIN, Texas--(BUSINESS WIRE)--Jun 1, 2012-- Austin Heart, the largest provider of cardiac and vascular services in Central Texasannounces 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.
Dr. Matthew Selmon, Dr. Roger Gammon, Dr. Marc Picone and Dr. Frank Zidar are interventional cardiologists at Austin Heart participating in the CONNECT II trial. Several patient cases have taken place at Heart Hospital of Austin this week and four are taking place today.
During the procedures, Austin Heart doctors will use Ocelot to help restore blood flow in completely blocked arteries in patients' legs through a simple two-millimeter skin incision, helping to avoid amputation.
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.
"Avinger's Dr. 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 national principle investigator, Dr. Matthew Selmon. "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-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 are minimally invasive and designed to allow patients to leave the hospital within hours, 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.
Austin Heart 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.
Austin Heart Austin Heart is the largest provider of cardiac and vascular services in Central Texas with 12 full-time office locations, 17 outreach clinics, and 45 cardiologists. Austin Heart has been serving the Central Texas area since 1973. Austin Heart's cardiologists sub-specialize in every diagnostic and treatment area of cardiovascular disease, America's No. 1 killer-interventional cardiology, electrophysiology, congestive heart failure, peripheral vascular disease, vein disease, sleep disorders, erectile dysfunction, imaging, women's cardiovascular health and a nationally recognized research department. To learn more about Austin Heart physicians, or to schedule an appointment, visit AustinHeart.com.
Heart Hospital of Austin Heart Hospital of Austin, located at 3801 North Lamar Boulevard, is part of St. David's HealthCare, one of the largest health systems in Texas, which was recognized as one of the top 15 health systems in the U.S. by Thomson Reuters in January 2012. Specializing in the diagnosis and treatment of cardiovascular disease, Heart Hospital of Austin is a shared vision of local cardiologists and cardiovascular surgeons.
Working with hospital leadership, the physicians created an atmosphere of quality, resulting in the leading cardiac program in Texas for six consecutive years as ranked by HealthGrades(R)-a leading independent health ratings organization. In July 2009, a study funded by the Centers for Medicare and Medicaid Services revealed that Heart Hospital of Austin was the leading hospital in the United States for treatment of a heart attack. Heart Hospital of Austin has also been named a top cardiovascular hospital in the nation by Thomson Reuters for six years, most recently being named to the list of 50 Top Cardiovascular Hospitals in 2011. In addition to providing a full range of cardiovascular services and an advanced Executive Wellness Program, Heart Hospital of Austin has a comprehensive 24-hour emergency department. For more information, please visit HeartHospitalofAustin.com.
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.
CONTACT: Austin Heart Shelley Reed, 512-610-2448 Shelley.Reed@HCAhealthcare.com or Mortar for Avinger Allyson Stinchfield, 415-772-9907 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA TEXAS INDUSTRY KEYWORD: HEALTH CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES FDA SOURCE: Avinger Copyright Business Wire 2012 PUB: 06/01/2012 09:00 AM/DISC: 06/01/2012 09:00 AM http://www.businesswire.com/news/home/20120601005204/