Boston Scientific Announces Position on FDA Update About use of Paclitaxel-coated Devices to Treat PAD

Marlborough, Massachusetts (12 July 2023) — Following yesterday’s news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD), Boston Scientific has announced its position on the update. The company’s full statement reads as follows:

On 11 July 2023, the FDA published a letter to healthcare providers stating that, based on its review of the totality of the available data and analyses, the excess risk of mortality associated with paclitaxel-coated devices to treat PAD is no longer supported. The letter recognises the safety of paclitaxel-coated devices and provides updated guidance that eliminates the requirement for device manufacturers to include specific warning language within device labelling.

“We are pleased that, after continued analysis of data and collaboration among a broad set of stakeholders, the FDA has determined the large body of long-term clinical data do not support an excess mortality risk for paclitaxel-coated devices used to treat patients with PAD,” said Michael R Jaff, chief medical officer and vice president, Peripheral Interventions, Boston Scientific. “We remain dedicated to helping physicians provide the best care possible for their patients through access to life-changing technologies, including the Eluvia drug-eluting vascular stent system (DES) and the Ranger drug-coated balloon (DCB), both of which have demonstrated excellent safety profiles and very low revascularisation rates in the hundreds of thousands of patients treated worldwide with these devices.”

Approximately 200 million people around the world are affected by PAD, a common circulatory problem in which plaque builds up and narrows arteries, consequently reducing blood flow to limbs.

The Ranger DCB has a low therapeutic drug dose and proprietary coating, which efficiently transfers the drug into the tissue, resulting in the highest primary patency rates from prior studies examining other peripheral DCBs. The low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy.

The Eluvia DES, which features sustained release of the lowest dose of paclitaxel for peripheral drug-eluting devices, re-opens blocked arteries and restores blood flow while utilising a drug-polymer combination to prevent excessive tissue regrowth. Eluvia has the highest primary patency and lowest revascularisation rates among stents used to treat PAD in the superior femoral artery (SFA) and has shown superiority in two randomised controlled comparative effectiveness trials.