FDA Approves Drug-Coated Balloon from C.R. Bard to Treat Peripheral Artery Disease

C. R. Bard Inc. received U.S. Food and Drug Administration (FDA) approval of the Lutonix 035 drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty (PTA, opening blocked arteries in the leg), after pre-dilatation, for the treatment of de novo or restenotic (re-blocked) lesions up to 150 millimeters (mm) in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix 035 DCB—according to the company, the first and only FDA-approved DCB in the United States—is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also uses standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoro-popliteal arteries.

Mount Sinai Hospital in New York, N.Y., was first in the United States to use the technology.

“I am excited to be first in providing this FDA approved technology to our peripheral arterial disease patients at The Mount Sinai Hospital,” said Prakash Krishnan, M.D., director of endovascular services at Mount Sinai Heart who performed the first case post-FDA approval on October 11 with Jose Wiley, M.D., and Bhaskar Purushottam, M.D., of Mount Sinai. “This drug coated balloon may be a game changer in the management of patients with peripheral arterial disease. It can effectively reduce the recurrence of blockages in patients, which can help prevent limb amputations, improve a patient’s quality of life, and also be lifesaving.”

The device is used during an angioplasty procedure in the cardiac catheterization laboratory for patients with peripheral arterial disease who have severely blocked femoro-popliteal arteries, major arteries that supply blood throughout the legs.  The balloon works to dilate a blocked artery restoring blood flow to the limb, while administering a therapeutic dose of the drug paclitaxel inside the artery to prevent it from narrowing in the future.

FDA was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol. At one year, the LEVANT 2 study demonstrated improved patency of the Lutonix 035 DCB compared to standard PTA: 73.5 percent vs. 56.8 percent.

It also demonstrated clinical benefits of sustained improvement in Rutherford Class and improved walking distance scores. The LEVANT 2 study followed a rigorous blinding protocol designed to reduce bias in the results to accurately and scientifically assess and compare the long-term performance of key clinical measures. The LEVANT clinical program, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to PTA, including the same low rate of distal embolic events and rate of reintervention for thrombotic events.

“The Lutonix 035 DCB provides physicians with an opportunity to enhance the treatment protocol for patients with occlusive disease of the femoropopliteal artery with a safe, effective method of delivering paclitaxel directly to stenosed vessels,” said Kenneth Rosenfield, M.D., section head, vascular medicine and intervention chairman, Massachusetts General Hospital, and professor of medicine, Harvard University School of Medicine and LEVANT 2 principal investigator. “This DCB is a new first-line therapy for treating blockages, without closing the door to other treatment options down the road. I envision also using the Lutonix 035 DCB to complement existing therapy options.”

The American Heart Association (AHA) estimates that PAD, a life-threatening condition, affects at least 8 million Americans by narrowing arteries and reducing blood flow to the limbs. Patients with PAD in the femoro-popliteal arteries are at risk for lower-extremity amputation, particularly in people over the age of 50. Successful treatment of PAD in the femoro-popliteal arteries requires improved blood flow (patency) for longer periods of time. While there are both non-invasive and invasive treatment options for these arteries available, each has associated limitations. PTA is currently the first-line, standard-of-care treatment for PAD, according to the American College of Cardiology and AHA 2011 guidelines; however, it is limited by its relative lack of long-term patency.

“In line with Bard’s commitment to delivering products that improve patient care, we are proud to offer another Bard first-of-its-kind innovation that expands therapy options for this painful, progressive and debilitating disease,” said Timothy M. Ring, chairman and CEO of C. R. Bard. “The Lutonix 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoro-popliteal occlusive disease.”

“Preventing future artery blockages is as important as opening the initial blockage,” said Krishnan. “This drug-coated balloon technology can help prevent further blockage in the artery.”

Mount Sinai was one of 54 sites in the world participating in the LEVANT 2 study, in which Krishnan served as principal investigator at Mount Sinai. He also is a consultant for C.R. Bard.        
                               
The Lutonix 035 DCB has been available in Europe since 2012.

C. R. Bard is headquartered in Murray Hill, N.J., and makes medical technologies in the fields of vascular, urology, oncology and surgical specialty products.