Both Medtronic and BD have released statements in response to the FDA circulatory system devices panel held last week (19–20 June, Washington, DC, USA). The companies reiterate the safety and efficacy of their own paclitaxel devices and state that patient safety is a priority.
For Medtronic, patient safety is our top priority—and has been since our company’s founding more than 60 years ago. These panel deliberations are critically important as the Food and Drug Administration (FDA), societies, physicians, and industry consider and address the recent questions around the safety of paclitaxel devices in peripheral arterial disease (PAD) above-the-knee. As an industry leader, we take our responsibility to patients and physicians very seriously and look forward to further collaboration on a response to the panel’s recommended next steps.
The Medtronic presentation included the independent, patient-level analysis from our two randomized controlled trials (RCTs)—IN.PACT SFA and IN.PACT Japan. This analysis also accounts for vital status data on 97% of patients from our RCTs, representing the highest rate obtained across all industry clinical data presented at the panel. Results demonstrate:
- No drug-related mechanism for observed transient mortality signal
- No observed dose relationship with mortality
- No pattern of adverse events or cause of death to suggest unifying mechanism
- No relatedness between deaths and paclitaxel, as adjudicated by a newly convened independent Clinical Events Committee (CEC) with paclitaxel toxicity expertise
Additionally, Peter A Schneider, MD, professor of Surgery, Division of Vascular & Endovascular Surgery, University of California San Francisco and principal investigator of the IN.PACT SFA trial, presented the clinical benefit of IN.PACT Admiral. In the IN.PACT SFA trial, three out of four DCB patients remained intervention-free through five years, and for DCB patients who required a repeat procedure, the time to reintervention was prolonged for more than two years. Medtronic remains confident that the IN.PACT Admiral benefit-risk profile is positive and supports IN.PACT Admiral DCB as a first-line strategy for the treatment of PAD.
The panel presentations and deliberations addressed a wide range of considerations related to paclitaxel drug-coated balloons (DCB) and drug-eluting stents (DES). Laura Mauri, MD, vice president, Global Clinical Research & Analytics, Medtronic also presented alongside Dan Clair, MD, chair of the Department of Surgery for the University of South Carolina (USC) and the Palmetto Health-USC Medical Group and Eric A Secemsky, MD, MSc, RPVI, FACC, FVSM, Beth Israel Deaconess Medical Center, Harvard Medical as part of an unprecedented pan-industry presentation.
Medtronic remains steadfast in our leadership and commitment to data transparency and continues to encourage collaboration across industry and regulatory stakeholders around the world to further address this issue.
The full statement from BD:
The panel discussed the benefits of paclitaxel-coated devices relative to the potential risks and noted strong evidence of benefit and recommended additional efforts to evaluate long-term safety. Additionally, BD presented its own data confirming that the benefits outweigh the risks for LUTONIX drug-coated balloons (DCBs) in SFA. Over the past several months, BD has been working diligently to obtain all available patient follow up data and collaborating with FDA, professional clinical organisations and industry to investigate the important issue of DCB safety. BD continues to stand behind the safety of its LUTONIX DCBs and is committed to improving the quality of life for patients with PAD. BD will continue to collaborate with FDA, industry and professional organisations to collect and analyse data for the benefit of patients. To ensure patients with PAD continue to receive the best care possible, BD will continue to ensure physicians and patients have access to BD’s broad range of treatment options for this serious disease.