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Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices Image by S. Hermann & F. Richter on Pixabay
"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," Surmodics CEO Gary Maharaj said about the company's SurVeil drug-coated balloon. Abbott will have exclusive worldwide commercialization rights for the device once it is approved.

Paclitaxel Controversy Is Causing CE Mark Delays for New Paclitaxel Devices

The fate of Surmodics' SurVeil CE mark submission is unclear as the European notified body has temporarily halted review of 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 arter disease in the upper leg.

"The results from TRANSCEND will ultimately provide insight into clinically important questions regarding long-term patient-level data out to five years, which is especially important given the current matter concerning paclitaxel-containing devices," Maharaj said.

Completion of the TRANSCEND enrollment triggered a $10 million milestone payment from Abbott Laboratories. The agreement between the two companies was formed in February 2018 and provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB. Abbott also paid Surmodics $25 million upfront.

Michael Petusky, an analyst at Barrington Research Associates, asked Maharaj if the holdup with the CE mark has changed the company's strategy at all in terms of how Surmodics will allocate capital to R&D projects this year and beyond.

"For the drug delivery programs, I mean, the European Union, clearly, is a significant market," Maharaj said. "And clearly, our commercialization partner, that's a commitment we made as part of this partnership to get [CE mark]."

But the company is seeing some lag in getting CE marks for non drug delivery devices too, he said.

"... And this is my opinion, even though the U.S. FDA and 510(k) program can take a couple of turns, we started recognizing that we're getting 510(k) [clearances] – I don't want to jinx it – faster than CE marks," Maharaj said. "And that's become of some bottleneck issues, and clearly, some of the MDR standards [that] are going to be in place here in May 2020. So pipeline analysis, it does come into play, because if it takes 1.5 years to get to CE mark for a market that's 20% the size of the U.S. market, we do have to fine tune that and decide where to allocate the capital."

That's not to say the company won't have devices on the market in the European Union, Maharaj said, but it does impact the timing of cash flow. It also has an impact on other geographies that use the CE mark to ease their regulatory reviews, he said.

As for the U.S. market, FDA did approve Medtronic's IN.PACT AV drug-coated balloon in November for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis. That approval was seen as a turning point in the conversation about paclitaxel devices, at least in the United States.

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