NEW HAVEN, CT (July 15, 2015) – Doctors at Yale New Haven Hospital (YNHH) were recently cited in a New England Journal of Medicine article summarizing the results of the LEVANT 2 clinical study, which found that the LUTONIX® 035 Drug Coated Balloon PTA Catheter (DCB) showed superiority compared with standard percutaneous transluminal angioplasty (PTA). The LUTONIX 035 DCB significantly improved the primary patency (openness of the vessel) when compared with standard PTA while also demonstrating safety consistent with the known safety standard for PTA balloons.
“This life-threatening condition affects at least eight million Americans by narrowing arteries and reducing blood flow to the limbs,” said Dr. Carlos Mena, electrocardiologist, Yale New Haven Hospital heart and vascular center. “Minimally-invasive endovascular procedures such as angioplasty balloons and stents, medications and vascular bypass surgery are some of the accepted ways to treat PAD, but these options may be limited depending on the type of arterial blockage.”
The LUTONIX 035 DCB, the first drug coated balloon approved by the U.S. Food and Drug Administration, is a first-line treatment option that can be used as a standalone therapy or in conjunction with existing therapeutic approaches while leaving future treatment options open for patients.
Peripheral Arterial Disease, also called PAD, occurs when blood vessels, tubes that carry blood to and from all parts of the body, are narrowed or blocked by fatty deposits and blood flow to feet and legs decreases. If you have PAD, you have an increased risk for heart attack and stroke, a condition caused by damage to blood vessels in the brain, which may cause loss of the ability to speak or to move parts of the body. An estimated one out of every three people with diabetes over the age of 50 have this condition.
“Our commitment to bringing state-of-the-art treatment options to our patients is reinforced by the recent publication of these data in The New England Journal of Medicine,” said Dr. Mena. “YNHH is the first to offer this treatment in Connecticut as part of our team’s ongoing dedication to helping patients manage this painful, progressive and debilitating disease. This new technology is an important tool for treating those suffering from PAD and we will continue to follow best practice results when making decisions about what devices and treatments work best.”
