US-based medical device maker C R Bard Inc yesterday said that it had purchased privately-owned Lutonix Inc for about $225 million, in order to acquire the technology for drug-coated balloons used in the treatment of peripheral arterial disease.
Lutonix, based in Minneapolis, Minnesota, is conducting the first and only investigational device exemption (IDE) trial approved by the US Food and Drug Administration (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 US.
Researchers are conducting the Levant 2 study which is a randomised, single-blinded, multi-centre pivotal IDE trial comparing the Lutonix drug-coated balloon to standard balloon angioplasty.
Lutonix received CE mark approval this year and Bard expects to start selling the device in Europe in the second half of 2012.