August 8, 2019

VIVA Physicians’ Analysis of Paclitaxel-Coated Devices Used to Validate FDA Safety Findings

The latest FDA update on paclitaxel-containing devices highlights VIVA Physicians’ analysis of patient-level safety data as validation of their findings. In their August 7th guidance, FDA states that clinical studies of these devices may continue.

VIVA Physicians is a not-for-profit organization dedicated to PAD education and research.

In March of 2019, VIVA Physicians hosted an invite-only special session of its Vascular Leaders Forum series, "Drug Elution in Peripheral Artery Disease (PAD): A Critical Analysis from a Multispecialty Consortium", in Washington, DC. The goal of this forum was to analyze a recent meta-analysis that associates drug-eluting technologies with increased mortality at 3 and 5 years.

The resulting paper, titled “Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients with Peripheral Artery Disease?”, integrates the data presented at the Vascular Leaders Forum and provides a review of the current evidence base and guidance for the clinical community.

Following the 2019 Vascular Leaders Forum, VIVA Physicians presented findings from their independent, patient-level data analysis of paclitaxel-containing devices at the FDA’s Circulatory System Devices Panel, which met June 19-20, 2019.

The paper, published in the June 2019 online edition of Circulation, is available here:

The entire August 7, 2019, statement from FDA is available here:

For questions specific to the Vascular Leaders Forum or the subsequent data analysis, contact