FDA Nixes, for Now, Lutonix Paclitaxel-Coated Balloon in PAD

Patrice Wendling

August 07, 2019

The US Food and Drug Administration (FDA) has rejected a premarket approval (PMA) application for the Lutonix paclitaxel-coated balloon (Becton Dickson & Co.) to treat peripheral artery disease (PAD) below the knee.

The interventional field has been in turmoil since evidence emerged last December of a late mortality signal in patients with PAD treated with paclitaxel-coated balloons and stents.

A June meeting of the FDA's Circulatory System Devices Panel advisory committee concluded that the devices should remain on the market but that the labeling should be changed to reflect the potential risk.

Becton Dickson was notified after the advisory committee meeting that the PMA was not approvable in its current form, BD chair and chief executive officer Vincent Forlenza told investors during an earnings call August 6.

"While this determination was based on the clinical evidence provided to date, we continue to review, collaborate, and align with the FDA on the path forward regarding our submission, including the need to potentially provide additional clinical data," Forlenza said. "As a result, the approval process timeline has extended out from our previous expectations and we no longer expect approval this calendar year."

The Lutonix DCB has been commercially available since 2012 and is indicated in the United States for percutaneous transluminal angioplasty (PTA) and for arteriovenous fistula.

During the FDA advisory committee meeting, BD officials reported a numerical, but not statistically significant, increase in the hazard ratio for mortality in patients treated with the Lutonix DCB vs uncoated PTA based on combined data from several trials. In the L2RCT study alone, the pivotal clinical safety study of the Lutonix DCB, the hazard ratio with treatment increased over time, from 1.14 (95% CI, 0.4 - 3.7) at year 1 to 1.68 (95% CI, 0.47 - 1.86) at year 5.

On the earnings call, company officials declined to specify whether the FDA was requesting a new trial or just longer-term data, but said it remains a very active PMA and that 6-month and interim 12-month data were included in the filed PMA.

"And we have more data to bring to the table," Forlenza said.

Although third-quarter revenues increased 5.2%, company officials noted that the results include a reduction of about 50% in planned DCB-related sales in the quarter.

Forlenza also announced that the company had withdrawn its application for approval of a type 2 insulin patch pump based on "comprehensive feedback" from the FDA and "intricacies" of the product category, but that it has taken on a third-party development partner to work through its options. "In the short run, we remained committed to the patch pump," he said.

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