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FDA approves drug-coated angioplasty balloon catheter for PAD treatment
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The FDA has approved a percutaneous transluminal angioplasty catheter with a drug-coated balloon for the treatment of peripheral artery disease.
The Lutonix 035 drug-coated balloon (Lutonix DCB; Lutonix Inc./C.R. Bard) is the first of its kind, and is intended to reopen superficial femoral and popliteal arteries that have become narrowed or blocked due to PAD, according to a press release.
Procedures incorporating the Lutonix DCB begin with a non-drug-coated balloon used to initially re-open the narrow or blocked artery. The Lutonix DCB, which includes a balloon coated with paclitaxel to prevent restenosis following the procedure, is then used to completely open the artery and apply paclitaxel to the artery wall, according to the release.
The approval follows results from multiple clinical studies. A multicenter European trial assessed the safety and efficacy of the device in a cohort of 101 patients randomly assigned to Lutonix DCB or conventional balloon angioplasty. In this trial, 71.8% patients who received treatment with Lutonix DCB did not require additional PAD therapy, compared with 48.6% of controls. A similar, single blind, multicenter trial in the US and Europe randomly assigned 476 patients to receive either conventional angioplasty or Lutonix DCB or standard angioplasty, and observed no restenosis in 65.2% of those in the Lutonix DCB group, compared with 52.6% of controls, according to the release.
An ongoing, single-arm safety trial of Lutonix DCB includes 657 patients throughout the US and Europe. Currently available results indicate no unanticipated device- or drug-related adverse events, according to the release. The most commonly reported major events across the studies have included need for additional therapy, pain due to poor blood flow, narrowing of untreated arteries, chest pain and abnormal tissue growth.
William Maisel
“Preventing further blockage of arteries is just as important as removing the initial blockage,” William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health, said in the release. “The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery.”
The FDA will require the company to conduct two post-approval studies, according to the release: A trial assessing safety and efficacy at 5 years in 657 recipients, and a single blind, multicenter trial evaluating Lutonix DCB in a cohort of women.
Perspective
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Gary M. Ansel, MD
With this approval, the United States finally caught up to much of the world in device availability for treatment of patients with PAD. Practicing physicians have eagerly awaited approval of a drug-coated balloon that has been available in Europe for over 6 years. This is a huge step forward in drug-based technology and compliments the availability of drug-eluting stents that were approved just under 2 years ago. The approval of the Lutonix DCB comes after a unanimous approval by the FDA advisory panel. The DCB met its safety and efficacy endpoints and trended to show improved clinical outcomes, which the study was not powered to obtain. This technology allows for improved technology over plain angioplasty without leaving a prosthetic stent device in the artery. Practicing physicians will now need to evaluate the data to decide on what type of blockages can be successfully treated without a prosthetic device, which can complicate retreatment when used.Click Here to Manage Email Alerts