June 19, 2019

VIVA Physicians Presents Findings from Patient-Level Data Analysis of Paclitaxel-Containing Devices

VIVA Physicians will present findings from independent, individual patient-level data analysis of paclitaxel-containing device at Circulatory System Devices Panel of the Medical Devices Advisory committee, which will meet June 19-20, 2019.

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.

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

This 1.5-day consortium brought together an international coalition of leading clinicians, including representatives from major medical societies, US regulatory agencies, patient advocacy experts, and representatives from the medical device industry.

The forum, funded solely by VIVA Physicians, brought comprehensive, balanced, and focused attention to historical and current safety and efficacy data; a regulatory perspective on the meta-analysis; and how clinicians and trialists should react to these findings.

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.

The paper, published in the June 2019 online edition of Circulation, is available here: https://www.ahajournals.org/do...

Live stream footage for June 19, 2019: http://fda.yorkcast.com/webcas...

Live stream footage for June 20, 2019: http://fda.yorkcast.com/webcas...

For questions specific to the Vascular Leaders Forum, contact press@vivaphysicians.org.