FDA approves Bard’s Lutonix DEB

C.R. Bard (NYSE:BCR) said today that the FDA granted pre-market approval for its Lutonix drug-eluting balloon for treating peripheral artery disease, well ahead of the company’s expectation for approval early next year.

The Lutonix device is the 1st DEB to hit the U.S. market. It’s designed to dilate obstructions in the superficial femoral or popliteal arteries and leave behind a therapeutic dose of paclitaxel, a drug that’s also used to coat drug-eluting stents.

In June, an FDA panel recommended that the watchdog agency approve the Lutonix device, which is designed to treat peripheral artery disease, voting unanimously that it is safe, effective and its benefits outweigh its risks. A month later Bard executives said the company was on track for an early 2015 approval from the FDA.

Dr. Ken Rosenfield, who designed and led the groundbreaking Levant II trial used to back Bard’s PMA bid, told MassDevice.com this morning that the FDA nod is a big step in treating PAD.

“This is the 1st drug-eluting balloon we’ll have access to in the U.S. and that’s definitely important. It’s a whole new class of therapeutic modality that’s available to us now. We’ve been waiting for it and it represents a big step for us here in the U.S. who are treating peripheral disease," Rosenfield told us.

The decision could also have some pull-through implications for Medtronic (NYSE:MDT) and its In.Pact Admiral DEB, which is still awaiting approval from the FDA, he added.

"Once you introduce a whole new class of therapy alternatives, then it probably opens doors for all of them that are in that same class," Rosenfield said. "Obviously the implication is that this type of device is now seen by FDA as having a potential therapeutic advantage."

The Levant II trial should serve as a model for other, similar trials in the future, Rosenfield told us.

"This trial represents a higher level of rigor in the conduct of clinical trials in the vascular space. I’m proud of that, because I helped design and run the trial. There was a lot of blinding built in, although we couldn’t blind the physicians because of the appearance of the balloon," he explained. "That’s the direction we need to go, to have more rigorously conducted trials that set a very high bar. This trial actually sets the highest bar in this space."

"In line with Bard’s commitment to delivering products that improve patient care, we are proud to offer another Bard first-of-its-kind innovation that expands therapy options for this painful, progressive and debilitating disease," Bard CEO Timothy Ring said in prepared remarks. "The Lutonix 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease."