Royal Philips : Philips’ response to updated FDA letter to healthcare providers on Paclitaxel Devices to treat peripheral artery disease

Stellarex is unlike any other DCB in the industry for the treatment of PAD as it features the EnduraCoat Technology, a unique coating consisting of polyethylene glycol as the base material, the so-called 'excipient', and a combination of amorphous and crystalline paclitaxel particles dispersed in it. EnduraCoat provides efficient drug transfer, effective drug residency with high coating durability and minimal particulate loss, and therefore enables a low therapeutic drug dose.

'Philips appreciates the thoughtful discussions we have had with the FDA, our industry partners, and physician leaders to help clarify the benefits and possible risks of paclitaxel-coated therapies,' said Chris Landon, Business Leader, Image Guided Therapy Devices at Philips. 'The safety of patients is our highest priority and we will continue to work with the FDA and our industry partners on further actions to assess the long-term safety and appropriately inform patients of the potential risk.'

Philips will continue to follow up on all its clinical trials including the ILLUMENATE Pivotal trial, the ILLUMENATE European Randomized Controlled Trial (EU RCT), and the ILLUMENATE SAVER registry. The company is also focused on continued enrollment in its ILLUMENATE Below the Knee (BTK) clinical trial.

Philips is committed to full transparency and cooperation with the FDA and other regulators.

[1] Low-dose DCBs are those that deliver a dose of only 2 micrograms of the drug paclitaxel per square millimeter, which is lower than some other DCBs on the market.

[2] Manuscript pending publication in a peer-reviewed clinical publication.