Medical device companies that sell paclitaxel-coated balloons or paclitaxel-eluting stents have been waiting to see what action FDA would take to address the late mortality signal associated with these devices. The agency provided some clarity around the issue on Wednesday that could drive a rebound in the utilization of paclitaxel devices.
Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the Circulatory System Devices Panel, FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies.
To see the list of specific questions the advisory panel tackled during the June meeting, click here.
"We believe the updated list broadens the patient population that may benefit from paclitaxel-coated devices," Needham & Co. analyst Mike Matson said in a report Wednesday. "We think that the updated recommendations could allow for paclitaxel-coated device utilization to rebound somewhat but probably not to the levels seen prior to the last FDA recommendations."
Matson estimates that the uncertainty around paclitaxel devices drove about a market decline of about 50%. That is consistent with what Becton, Dickinson and Company (BD) reported earlier this week. FDA rejected BD's application to approve the Lutonix drug-coated balloon to treat patients with below-the-knee peripheral artery disease.
DA said it is working with manufacturers on updates to device labeling and clinical trial informed consent documents to incorporate information about the late mortality signal. The agency said it is also actively working with manufacturers and investigators on additional clinical evidence development for assessment of the long-term safety of paclitaxel-coated devices.
FDA also released the following seven recommendations for doctors treating patients with paclitaxel balloons and stents:
- Continue diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- When making treatment recommendations, and as part of the informed consent process, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
- Discuss the risks and benefits of all available PAD treatment options with your patients. For many patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents provide a more favorable benefit-risk profile based on currently available information.
- For individual patients judged to be at particularly high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.
- In discussing treatment options, physicians should explore their patients' expectations, concerns and treatment preferences.
- Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.
- Report any adverse events or suspected adverse events experienced with the use of paclitaxel-coated balloons and paclitaxel-eluting stents. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.