C.R. Bard has purchased Lutonix, manufacturer of a drug-coated
percutaneous transluminal angioplasty balloon, for approximately $225 million,
with an additional $100 million to be paid to Lutonix with the pre-market
approval of the percutaneous balloon.
According to a press release, the acquisition is structured as a merger,
which C.R. Bard expects will reduce 2012 earnings per share by approximately 25
cents, excluding items that affect comparability.
Currently, Lutonix is conducting an investigational device exemption
trial testing drug-coated balloons for the treatment of peripheral arterial
disease, an indication currently untreated by any such device in the United
States. The randomized, prospective, single blind, multicenter LEVANT 2 trial
will compare the drug-coated balloon to standard balloon angioplasty in 476
patients with significant stenosis of the superficial femoral artery or
popliteal artery with lesions up to 150 mm in length. The trial will be
conducted in 55 sites in the United States and Europe.
In 2011, Lutonix received CE mark approval for its drug-coated balloon,
and C.R. Bard expects to begin selling the device in Europe in the second half
of 2012. C.R. Bard has also begun planning a larger registry study concurrent
with the launch in Europe to gather additional clinical data and support
broader marketing claims.