Becton Dickinson and Co. said it is confident in the safety of its Lutonix drug-coated balloon after the U.S. Food and Drug Administration alerted the public to a potentially higher risk of premature death in cardiovascular patients treated with such devices.
The Franklin Lakes, N.J.-based medical device-maker cited evidence from seven separate studies confirming the safety and effectiveness of the paclitaxel-coated Lutonix balloon, which is used to treat narrowed or blocked blood vessels by inflating the balloon to open the vessel.
Becton Dickinson said it will collaborate with the FDA and a nonprofit vascular medicine organization, the VIVA Physicians Group, to support an independent patient-level analysis to be completed before an FDA advisory committee meeting in June.
In January, the FDA said in a letter to physicians that an analysis of trial data published in the Journal of the American Heart Association indicated a potentially higher risk of premature death in patients who had been treated for peripheral arterial disease with paclitaxel-coated devices. The agency noted that no specific cause for the finding had been pinpointed.
Peripheral arterial disease is a circulatory condition in which narrowed arteries reduce blood flow to the patient's limbs. Paclitaxel-coated balloons and stents are known to improve blood flow to the legs and decrease the likelihood of repeat procedures to reopen blocked blood vessels.
The U.S. regulator then conducted a preliminary analysis of long-term data for such products. The FDA's initial analysis covered data from 975 patients in three clinical trials. Becton Dickinson said in its March 21 statement that the three studies were completed by Becton Dickinson, Medtronic PLC and Cook Medical Inc.
In March, the FDA said that analysis suggested a 50% increased risk of mortality in patients treated with paclitaxel-coated products compared with those who received other devices.
The FDA was cautious about the findings, saying the studies were not originally designed to be pooled and the cause and mechanism of increased mortality are unknown. The regulator added that the limited amount of data may skew the results.
The agency plans to conduct additional analyses and also check data on patients treated with these devices for other indications, such as arteriovenous access stenosis or critical limb ischemia.
"We continue to be dubious on the mortality signal," Morgan Stanley analyst David Lewis wrote in a March 21 note to clients. "While we expect additional data sets could come in the coming weeks, we think the FDA panel, expected in June, will be the next key catalyst for the [drug-coated balloons]."
Lewis rates Becton Dickinson stock equal weight and has a price target of $255 a share.