Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

Tension over stents and balloons that are either coated with or are designed to release paclitaxel has eased up in the United States, but across the pond may be a different story. The meta-analysis published in late 2018 that showed an increased risk of death for patients treated with paclitaxel devices seems to have given European regulators pause with regards to these devices. Eden Prairie, MN-based Surmodics submitted all the required modules for its SurVeil drug-coated balloon (DCB) to the European notified body before the end of the company's fiscal year 2019, but CEO Gary Maharaj said the organization has temporarily halted CE mark reviews for new paclitaxel devices pending more follow-up data from studies on current paclitaxel devices. "We have had ongoing communications with the notified body, but do not yet have a clear line of sight on the timing and probabilities of obtaining the CE mark," We do, however, remain quite confident in the strength of data that support the granting of a CE mark for SurVeil," Maharaj said during the company's fiscal first-quarter earnings call, according to SeekingAlpha transcripts. As MD+DI previously reported, Surmodics has completed enrollment of its TRANSCEND clinical study, which enrolled 446 patients across 65 global sites. The study is designed to evaluate the safety and efficacy of the SurVeil DCB compared with Medtronic's commercially available In.Pact DCB in treating peripheral ar...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news