WASHINGTON, D.C. – Cardiovascular Research Technologies (CRT) 2019 will feature a Drug-Coated Balloon Mortality Town Hall, which will include a panel of experts who will discuss the impact of the latest data on all-cause mortality associated with paclitaxel-coated devices, CRT Course Chairman Ron Waksman, MD, announced.
Investigators, industry and the U.S. Food and Drug Administration (FDA) will participate in the daylong town hall, scheduled for Tuesday, March 5, 2019. Jeffrey J. Popma, MD, FACC, of Beth Israel Deaconess Medical Center, Boston, Massachusetts, will chair the panel, which will feature discussion on a range of topics, including:
- Are there enough data to support concerns of paclitaxel toxicity with the use of paclitaxel-coated balloons or paclitaxel-eluting stents for clinical use in the superficial femoral artery (SFA) below the knee or in coronary arteries?
- Should the current labeling for drug-coated balloons (DCB) and drug-eluting stents (DES) in the U.S. for the treatment of occlusive SFA disease be restricted or changed? If so, how should the labeling be modified?
- What post-application studies should be recommended to assure safety and efficacy of DCB and DES with paclitaxel for the treatment of peripheral occlusive disease?
Afterward, the panel will vote on recommendations for how to proceed with paclitaxel devices in the treatment of peripheral artery disease.
The town hall will be open to CRT attendees. CRT is calling for presentations from academicians, industry and the FDA.
Interested presenters should click here by Feb. 5, 2019. CRT and the town hall chairs will select the appropriate presentations for the hearing.
Selected presenters will be notified by Feb. 12 and will need to submit their draft presentations by Feb. 25.
CRT 2019 will take place from Saturday, March 2, through Tuesday, March 5, at the Omni Shoreham Hotel in Washington, D.C. For more information on the interventional cardiology conference, please visit http://www.crtmeeting.org.