Heart Hospital of Austin/Austin Heart Enroll First Texas Patient in Study to Determine Effectiveness of Drug-Coated Balloon in Treating Patients with Peripheral Arterial Disease
AUSTIN, Texas—In September 2011, Heart Hospital of Austin and Austin Heart enrolled the first patient in a clinical trial known as the LEVANT 2, a global, multicenter, randomized study evaluating the effectiveness of the Moxy™ Drug Coated Balloon compared to a standard angioplasty balloon for treating patients with Peripheral Arterial Disease (PAD). Heart Hospital of Austin/Austin Heart is one of only 55 global centers selected for this study, and it is the only site in Texas.
“Anytime we perform procedures on diseased vessels, hyperproliferation—a rapid rate of cell division—can occur, leading to the presence of scar tissue that may cause a recurrent blockage in the artery,” Roger Gammon, M.D., interventional cardiologist at Heart Hospital of Austin, director of research at Austin Heart and principal investigator for the Levant 2 study, said. “Earlier studies from Europe suggest that treatment with drug-coated balloons may inhibit the scar tissue and improve the chance the vessel will remain open. This is the first such study in the United States using a drug-coated balloon. We strive to provide the most innovative and progressive care to our patients and are honored to be selected for this landmark trial.”
The Moxy balloon delivers an anti-proliferative drug to the artery in a single, 30-second inflation and is then removed from the body. The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with paclitaxel, which inhibits cell division, and a carrier molecule that facilitates rapid drug transfer upon inflation. This proprietary formulation allows delivery of a therapeutic drug dose to inhibit narrowing of the blood vessels, while permitting restoration of the artery’s inner surface.
According to the National Institutes of Health, 8 to 12 million people in the United States have PAD. Although conventional stent and balloon treatments are available, achieving long-term effectiveness is often a challenge. Many patients develop long areas of plaque deposits or total occlusions in the leg arteries that make walking difficult or impossible. Although conventional balloon procedures may partially open the artery, recurrent blockages are common due to recoil and scar tissue. Stents may provide more complete opening initially, but—by being a permanent implant—cause more scar tissue in the long run. Drug-coated balloons may offer a much-needed, new solution by combining the therapeutic simplicity of balloon angioplasty with the power of drugs to help keep the artery open over time. This technology enables physicians to deliver the drug directly to the artery without leaving a permanent implant, such as a stent, behind.
Lutonix, the manufacturer of the drug-coated balloon, received approval from the U.S. Food and Drug Administration in June to begin enrollment in the LEVANT 2 investigational device exemption clinical trial for the treatment of PAD, along with the receipt of CE Mark (legal requirement for medical devices intended for sale in Europe) for its drug-coated balloon and certification by the International Organization for Standardization.
The Moxy balloon is a therapy only available to participants of the LEVANT 2 clinical trial and is not approved for commercial use in the United States.
Heart Hospital of Austin
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®—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.
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.
About the Moxy Drug Coated Balloon
The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with an anti-restenotic drug designed to help keep arteries open and free from re-blockage. During the procedure, the Moxy balloon is inflated for 30 seconds during which it opens up the artery to restore blood flow, and delivers the drug into the artery wall. The Moxy balloon is then removed from the body leaving nothing behind but the drug coating, which works inside the artery over time to prevent restenosis. The Moxy balloon is an investigational device, which is not approved for, or available for sale in, the United States.
Restenosis refers to the re-narrowing of an artery following angioplasty or stenting. Restenosis is caused by an overgrowth of tissue inside the artery, typically in response to arterial injury at the original treatment site. Restenosis often occurs within the first six months following an intervention, and most often results in re-treatment.