Bard Acquires Lutonix

December 20, 2011—CR Bard, Inc. (Murray Hill, NJ) announced that it has acquired Lutonix, Inc. (Maple Grove, MN) for approximately $225 million to be paid at closing, with an additional $100 million to be paid upon United States regulatory approval of Lutonix's drug-coated percutaneous transluminal angioplasty balloon.

Bard stated that Lutonix is conducting the pivotal LEVANT 2 study in support of an anticipated submission for premarket approval (PMA) to the US Food and Drug Administratrion (FDA) for the drug-coated balloon for the treatment of peripheral arterial disease.

LEVANT 2 is an FDA-approved investigational device exemption trial. The prospective, randomized, single-blinded, multicenter trial is comparing the Lutonix drug-coated balloon to standard balloon angioplasty. The trial will enroll 476 patients at 40 sites in the United States and 15 sites in Europe. Eligible patients for the trial have significant stenosis in previously unstented superficial femoral artery or popliteal artery lesions up to 150 mm in length. Patients will be followed for 5 years.

Enrollment in LEVANT 2 commenced in July 2011, as reported in Endovascular Today. To date, Lutonix has enrolled more than 160 patients. Bard stated that the PMA submission will occur after 1 year of follow-up, which the company anticipates will be in 2014.

Lutonix received CE Mark approval in 2011, 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.