C.R. Bard (NYSE:BCR) won a date for an FDA panel review next for its Lutonix drug-eluting balloon in treating peripheral artery disease, ahead of its bid for approval to put the device on the U.S. market.
The FDA’s Circulatory System Devices Panel is slated to meet June 12 to review Bard’s pre-market approval application for the Lutonix balloon, which is coated with the anti-restenosis drug paclitaxel.
Bard, which bought Lutonix for $325 million in late 2011, is seeking approval for the Lutonix device for treating occlusions in the femoropopliteal arteries. The company filed the last module in its PMA application in November 2013.
The FDA advisory panel will review data from Bard’s Levant-2 clinical trial, which showed a significant difference in restenosis but no difference in target lesion revascularization at 6 months. Bard held the 12-month data close to its chest, giving the FDA the 1st look at those results as part of its PMA bid.
Medtronic (NYSE:MDT) is hot on Bard’s heels in the peripheral artery disease market with its In.Pact Admiral drug-eluting balloon. Results from the In.Pact SFA trial, announced April 5 at the Charing Cross international symposium in London, showed TLR rates of 1.4% for the In.Pact Admiral device, compared with 6.4% for the control arm. Bard’s Lutonix device and the control arm in its trial both showed TLR rates of about 3% at 6 months.
Although the FDA isn’t bound by the recommendations of its advisory panels, it often goes along with their recommendations.