C. R. Bard has acquired Lutonix for a purchase price of approximately $225 million paid at closing, with an additional $100 million to be paid upon pre-market application (PMA) approval of Lutonix’s drug-coated percutaneous transluminal angioplasty (PTA) balloon.
The transaction is structured as a merger, according to the Murray Hill, N.J.-based Bard.
Lutonix, located in Minneapolis, is conducting an investigational device exemption (IDE) trial approved by the FDA using drug-coated balloons for the treatment of peripheral arterial disease. To date, no such device is approved for use in the U.S.
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 U.S. and 15 in Europe. Lutonix began recruiting patients in the third quarter of 2011 and has enrolled more than 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 FDA 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.
Bard said it expects this transaction to reduce 2012 earnings per share by approximately 25 cents, excluding items that affect comparability.