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# Hard to Reach Conclusions on Lutonix Catheter: FDA
- URL: https://www.fdaweb.com/hard-to-reach-conclusions-on-lutonix-catheter-fda/
- Published: 2021-02-16T12:00:00.000Z
- Updated: 2026-09-14T16:46:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148672

An FDA briefing document released in advance of a 2/17 meeting of the Cardiovascular Devices Panel that will consider a PMA application submitted by Lutonix for its 014 drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter says that limitations associated with the primary and supplementary data in the application make it challenging to draw conclusions regarding the safety and effectiveness of this device. The document [says](https://www.fda.gov/media/145864/download?ref=fdaweb.com) that to date FDA has not noted any safety concerns associated with using the catheter that would be expected to exceed those of current standard of care with non-drug-containing devices.

“A modest benefit in regard to the primary effectiveness endpoint compared to PTA can be seen at six months but a reversed outcome was noted at 12 months and beyond,” the document says…. “Overall, the study was terminated early and did not meet the pre-specified hypothesis test success criteria. It remains unclear whether the effectiveness differences at six months are clinically meaningful and that the benefits of the paclitaxel-coated Lutonix 014 DCBN outweigh the risks compared to treatment with an uncoated balloon for treatment of atherosclerotic lesions below the knee.”

FDA says that if approved, the Lutonix device would be the first device other than PTA and atherectomy to be indicated for treating below-the-knee critical limb ischemia in the U.S.

An IDE for the catheter was first submitted to FDA 1/2013 and disapproved 2/8/2013\. The agency later conditionally approved the IDE 4/18/2013, with full approval granted 5/30/2013\. The original IDE was approved for 480 subjects with a primary safety endpoint of freedom from below-the-knee major adverse limb events and a primary effectiveness endpoint of a composite of limb salvage and primary patency at 12 months, later changed to six months.

Since the original approval, FDA says, the sponsor submitted 34 IDE supplements requesting modifications to the device design, manufacturing, and clinical study protocol.

The PMA was submitted 10/9/2018\. It has gone through a major deficiency letter, agency directed assignment review, and two not-approvable decisions.