Following the latest information presented at the Charing Cross International Symposium related to the meta-analysis of paclitaxel-coated devices (Katsanos et al. JAHA), hear from a multi-specialty panel of global experts who are discussing their current practice and the way they inform patients.
On March 15, the FDA published a letter to US Health Care Providers following an initial review of all available paclitaxel-coated devices. As always, patient safety remains our top priority and we are working with the FDA in a very transparent manner to help answer questions about the safety of these devices.
At Boston Scientific, we have worked diligently over the years to deliver meaningful innovations for your patients supported by Level 1 evidence. We believe paclitaxel is safe and will work transparently with all stakeholders to continue to move the field forward.
Paclitaxel-based endovascular devices have represented a significant advancement in treatment options for patients with peripheral artery disease. These devices have significantly reduced restenosis rates by up to 50% compared to non-coated devices and have helped hundreds of thousands of patients avoid costly and potentially hazardous reinterventions. We continue to believe in both the safety and efficacy of Boston Scientific’s paclitaxel devices, the Eluvia Drug-Eluting Stent and the Ranger Drug-Coated Balloon. Based on all available clinical data specific to Boston Scientific paclitaxel devices out to 3 years, we have not observed any safety signal in all-cause mortality rates .
Patient-level data reveals similar causes of death for paclitaxel-treated and non-paclitaxel treated patients.
CEC, Clinical Events Committee.
*The CEC considered all deaths cardiac unless an unequivocal non-cardiac cause could be established.
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