Dive Brief:

• The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) cast further doubt Tuesday on safety and effectiveness of paclitaxel-administering devices with new recommendations to healthcare providers informed by its expert advisory group (EAG). MHRA formed the investigative group in March to assess the devices' safety, using data from Bard (BD), Biotronik, Cook, Medtronic and others.
• "Do not use paclitaxel drug coated balloons (DCBs) or drug eluting stents (DESs) in the routine treatment of patients with intermittent claudication until further notice, as the potential mortality risk generally outweighs the benefits," the regulatory body said in the notice to surgeons and radiologists.
• MHRA noted the benefits of paclitaxel DCBs and DESs may outweigh risks in patients with critical limb ischaemia, given the population's higher risk of irreversible ischemic damage resulting from restenosis and lower life expectancy. The regulatory body said it will also share a review of results from clinical trials examining use of the devices in patients with arterio-venous fistula once available.

Dive Insight:

The latest MHRA communication comes just two weeks before FDA will hold a two-day meeting addressing the devices' safety profile. A meta-analysis signaling heightened mortality rates tied to paclitaxel DCB and DES-driven treatment, published in December, kicked off scrutiny of the devices. FDA formally recommended against use of the devices in most peripherial arterial disease patients in March.

BD, Boston Scientific and Medtronic all tempered expectations for sales of paclitaxel-administering devices on recent earnings calls, saying numbers could be largely contingent on the outcome of FDA's meeting.

"It is accepted that the causal relationship between paclitaxel coated devices and mortality is not yet understood and requires further evaluation," the MHRA notice said. "However, having taken account of the EAG's findings, together with other relevant information and opinions, MHRA considers the current evidence does not support the routine use of paclitaxel DCBs or DESs in patients with intermittent claudication."

MHRA recommended that if healthcare providers find individual cases support use of a paclitaxel DCB or DES they ensure patients are informed of the uncertainty surrounding long-term outcomes with the devices, and that current evidence indicates an increased mortality rate.

Regulators also emphasized new or existing paclitaxel DCB or DES patients should receive enhanced lifelong follow-up, and that any adverse events be reported appropriately.

The FDA meeting is slated for June 19-20.