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August 6, 2019
Medtronic Addresses FDA Update on Paclitaxel Devices to Treat PAD
August 7, 2019—Medtronic, manufacturer of the In.Pact Admiral paclitaxel-coated balloon, issued a statement regarding the FDA's updated Letter to Healthcare Providers in patients with peripheral artery disease (PAD) in the superficial femoral artery.
The company stated the following:
"Medtronic would like to thank FDA and the panel members for their thoughtful deliberations and dedication to providing physicians, patients, and administrators with updated recommendations following the Advisory Committee meeting of the Circulatory System Devices Panel in June. The next steps as outlined by FDA are critical to ensuring that physicians and their patients with PAD retain the option to utilize paclitaxel-coated therapies. The In.Pact Admiral drug-coated balloon (DCB) has demonstrated a clear positive benefit on clinical outcomes and quality of life across multiple randomized controlled clinical trials.
"Medtronic is encouraged by this path forward, but our work to evaluate the root cause of this safety signal is not complete. It is important to remember that causality was not able to be established in the FDA or VIVA/NAMSA analyses. Therefore, it is critical that Medtronic and our industry partners continue to work together to share safety and effectiveness data to further facilitate the benefit-risk conversation. This work is consistent with the Medtronic Mission, and we look forward to continued collaboration with physician societies, FDA, and our industry partners throughout the next phase of this effort."
The company summarized the FDA guidance as allowing:
- Physicians and patients to discuss the benefits and risks of all available PAD treatment options to support an informed treatment decision
- Patients to have continued access to paclitaxel devices as a first-line treatment option, particularly those at high risk of restenosis
- Trial sponsors to continue enrollment in clinical studies to further evaluate the long-term safety and effectiveness of paclitaxel devices
- FDA and industry to analyze of additional randomized controlled trials and registry data sets to help provide more insights into the mortality signal in question
According to Medtronic, the safety and effectiveness of In.Pact Admiral was demonstrated by the IN.PACT SFA trial, in which three out of four DCB patients remained intervention-free through 5 years; additionally, for DCB patients who required a repeat procedure, the time to reintervention was prolonged for more than 2 years. In line with FDA’s recommendations, Medtronic encourages physicians to talk to their patients about the benefits and risks of all available treatment options.
All articles from Endovascular Today's continuing coverage of the paclitaxel safety data review are available online here.
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