C.R. Bard (NYSE:BCR) said its application for pre-market approval of the Lutonix drug-eluting balloon is complete now that the final module has been filed with the FDA.
The Lutonix balloon is designed to treat peripheral artery disease by delivering the drug paclitaxel to the arterial wall. The device met its safety and efficacy endpoints in clinical trial results released last month, but questions remain regarding its efficacy compared with standard balloon angioplasty.
Endpoints for the Levant-2 trial are patency of the target lesion and lack of restenosis after a year. Six-month data, presented at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco, revealed that 92.3% of the Lutonix cohort showed primary patency, compared with 82.7% of the control group. But TLR rates for both arms were about 3%, casting doubt on the chances for FDA approval if the 12-month results are similar.
Bard executives are confident that the 12-month data from Levant-2 will alleviate those concerns. Bard’s senior vice president of science technology & clinical affairs, John DeFord, told analysts last month that the 12-month results met both the safety and efficacy endpoints. But Bard hasn’t released the 12-month results yet, saying it wants to give the FDA the 1st outsider’s look at the data.
"[W]e completed the 1-year follow-up of the Levant 2 study for the treatment of [superficial femoral artery disease] and popliteal disease in Q3. Though we continue to work through this data to finalize our analysis and the clinical study report, we are very pleased to say that at this point, the results indicate that we met both our primary safety and efficacy endpoints," DeFord said in October. "We know everyone’s anxious to know more about our results. However, we’re sticking with the plan we articulated several months ago to preserve the 12-month randomized data for a first look by the FDA."
With the final module submitted, it’s now up to the federal watchdog agency to determine whether the Lutonix device, which Bard acquired for $325 million in late 2011, is safe and effective enough for the U.S. market.
"This submission marks a key milestone in our drug-coated balloon program, which continues to progress as expected. We look forward to interfacing with the FDA for the purpose of making this important technology available to U.S. patients," chairman & CEO Timothy Ring said in prepared remarks.
