The US Food and Drug Administration (FDA) has issued a letter to healthcare providers updating them on the risk of mortality from the use of paclitaxel-coated devices in the treatment of peripheral arterial diseases (PAD).
The devices include paclitaxel-coated balloons and paclitaxel-eluting stents which are used to treat new and repeated atherosclerotic lesions in the femoropopliteal artery in the upper leg by opening blocked blood vessels. According to the FDA, evidence shows these devices can improve blood flow in the legs reducing the need for repetitive surgeries to open the vessels.
Using all the data and analyses available, the FDA came to the conclusion that the data does not support a greater mortality risk in the use of paclitaxel-coated devices.
In a letter to healthcare providers, the FDA recommended they talk about the risks and benefits of PAD care with patients while continuing to monitor patients undergoing treatment with the devices. They also advised them to continue medical therapy for PAD and cardiovascular risk factors while reporting any negative events that the patient may experience.
In 2019, data supported concerns of increased mortality risks from these devices but since then new data from randomised controlled trials (RCTs) has emerged.
Medical device companies have collaborated combining studies using more complete vital status information, and longer-term follow-up compared to prior research.
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Device manufacturers collaborated in an updated meta-analysis, which included additional studies, more complete vital status information, and longer-term follow-up compared to prior studies. Reviewed by FDA clinicians and statisticians, it showed that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.
Other studies reviewed by the FDA include the SWEDEPAD trial interim analysis, the VOYAGER PAD study, the German BARMER Health Insurance study, the US Veterans Health Administration study, and the Medicare SAFE-PAD study. The FDA plans to follow-up on several of these studies which are ongoing.
In February 2023, the FDA granted investigational device exemption (IDE) approval to Concept Medical’s Magic Touch Sirolimus Coated Balloon. The coated balloon catheter is developed to treat below-the-knee (BTK) atherosclerotic lesions in PAD.
According to a report from GlobalData it is estimated that the drug-coated balloons and stents market will grow at a compound annual growth rate (CAGR) of 12% worldwide by 2028. Although this figure could have been subject to change from previous data on mortality risks.