FDA Resets PAD Guidelines: The Road Ahead for Device Makers

Following the FDA’s last-week announcement of its renewed guidance on the treatment of peripheral artery disease (PAD), medical device companies sound upbeat about the development so far.

More precisely, the updated guidance for the physicians is related to the benefit-risk profile of peripheral paclitaxel devices intended for the treatment of PAD.

The FDA Statement

Earlier in 2019, the FDA had notified health care providers about a late mortality signal in patients treated for PAD in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents.

In its revised guidance, the regulatory body has provided the advisory panel’s analyses and recommendations for healthcare providers. It has also laid an emphasis on taking additional steps to address this signal including coordination with manufacturers on updates to device labeling and clinical trial informed consent documents for incorporating information about the late mortality signal.

Among the recommendations, the FDA noted that health care providers should discuss the risks and benefits of all available PAD treatment options with patients. This is because for many patients, alternative treatment alternatives like paclitaxel-coated balloons and paclitaxel-eluting stents mete out a more favorable benefit-risk profile.

The FDA has also asked the clinicians to determine whether the benefits of using a paclitaxel-coated device (in patients at particularly high risk for restenosis and repeat femoropopliteal interventions) outweigh the risks of late mortality.

MedTech Makers’ Rejoinder

Medical device major Boston Scientific Corporation BSX is pleased about the FDA’s recommendation as this will allow physicians to continue accessing the company’s Eluvia Drug-Eluting Vascular Stent (DES) System. Per Boston Scientific, Eluvia has already demonstrated an excellent safety profile and a very low revascularization rate of 12.9% at two years in the pivotal IMPERIAL trial including many complex PAD patients.

Medtronic MDT too is optimistic about the FDA’s guidance, which it claimed has fueled the company’s growth in the PAD treatment market. According to the company, its IN.PACT Admiral drug-coated balloons (DCB) have clear benefited the clinical outcomes and improved the quality of life across multiple randomised controlled clinical trials. Per the IN.PACT SFA trial result, three of the four DCB patients remained intervention-free through five years. While those requiring a repeat procedure, the time to reintervention was more than two years.

However, as a major setback, Becton Dickinson & Co. BDX has announced that post the FDA Advisory Committee meeting on paclitaxel, the regulatory agency has notified that it is not going to grant any PMA (Premarket Approval)to the company’s Lutonix drug-coated balloon catheter for use below the knee.

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