Lutonix, located in Minneapolis, Minnesota, is conducting the first and only investigational device exemption (IDE) trial approved by the FDA using drug-coated balloons for the treatment of peripheral arterial disease. Drug-coated balloons have received growing attention in recent years as physicians look for effective ways to treat diseased arteries without having to leave a permanent implant behind. Independent forecasts suggest that the global peripheral vascular market for drug-coated balloons could approach $1 billion annually over the next decade. To date, no such device is approved for use in the United States.
The Lutonix LEVANT 2 study is a prospective, randomized, single-blinded, multi-center pivotal IDE trial comparing the Lutonix drug-coated balloon to standard balloon angioplasty. The trial will enroll 476 patients across 55 sites, including 40 in the United States and 15 in Europe. Lutonix began recruiting patients in the third quarter of 2011 and has enrolled over 160 patients to date. Eligible patients suffer from significant stenosis in previously unstented superficial femoral artery or popliteal artery lesions up to 150 mm in length. These patients will be followed for five years, with PMA submission after one year of follow-up. At this time, the company anticipates that submission could occur in 2014.
Lutonix received CE mark approval this year and Bard expects to start selling the device in Europe in the second half of 2012. The company plans to begin a larger registry study concurrent with the European launch to support broader marketing claims and obtain additional clinical data.
Timothy M. Ring, Bards chairman and CEO, commented, "In our evaluations, Lutonix has the only third-generation drug-coated balloon technology. They also have a significant lead with respect to U.S. launch, outstanding quality and depth of pre-clinical science, a strong clinical program, a very skilled and motivated team, and a coating technology we believe will demonstrate superior safety and efficacy. This position of leadership in a large potential market, combined with our current market leadership in PTA, makes this acquisition a compelling strategic fit for Bard."
Bard expects this transaction to reduce 2012 earnings per share by approximately 25 cents, excluding items that affect comparability.
C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.
Posted by Sean Fenske, Editor-in-Chief, MDT