Almost a year ago C.R. Bard announced that it had submitted the final module of its U.S. FDA submission that would see it gain a first approval for a drug coated vascular balloon. Now the dream has become reality as Bard confirms approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA). Indications extend to use after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.
Peripheral Artery Disease (PAD) reportedly affects at least 8 million Americans by narrowing arteries and reducing blood flow to the limbs, and carries a significant risk for lower-extremity amputation, particularly in femoro-popliteal disease in people over the age of 50. PTA is currently the first-line, standard-of-care treatment, despite being limited by its relative lack of long-term patency.
Available commercially in Europe since 2012, the Lutonix® 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel. It also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries. Significantly the FDA’s approval was supported by the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol.
At one year, the LEVANT 2 study showed that the Lutonix® 035 DCB yielded 73.5% patency compared to 56.8% for standard PTA (p<0.001 by Kaplan-Meier time-to-event analysis). 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.
Approval follows a unanimous favourable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014.
“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, 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.”
“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 chief executive officer of C. R. Bard. “The Lutonix® 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease.”
Source: C.R. Bard, Inc., Business Wire