Surmodics Turns Year Around with SurVeil Approval

Surmodics has won a nod from FDA for its SurVeil drug-coated balloon after the agency said the device was not approvable in January.  

FDA’s nod comes about three years after Surmodics won CE mark for SurVeil.

The Eden Prairie, MN-based company’s device is designed to treat peripheral artery disease (PAD). The device includes a proprietary drug-excipient formulation using a special process to improve coating uniformity.  

The device is designed to use a lower paclitaxel drug dose of 2.0 μg/mm2 and to have better efficiency of drug transfer. The aim was to achieve similar clinical outcomes with a lower dose of drug, potentially lowering the risk of complications.

"Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics' history," said Gary Maharaj, the company's CEO, in a news release. "It represents a major milestone in our efforts to develop next-generation products to help millions of people."

FDA initially did not approve the device because it wanted to see additional information regarding the biocompatibility of the device and the labeling, which would require additional testing and analysis. However, the agency did not question the human clinical data submitted, nor did it ask for additional clinical data.

Approval for the device caused shares of Surmodics to go up as high as 16% on Tuesday. Conversely, when news of a delay in approval hit, Surmodic’s shares dropped as much as 30%.

The question of SurVeil’s approval has been a hot-button topic that has had an impact on the company. Surmodics had to cut about 13% of its workforce to reduce cash burn, as a result of FDA not approving the device in January.  

The delay also had the potential to jeopardize Surmodics’ commercialization agreement with Abbott Laboratories. The approval of SurVeil now triggers $27 million in milestone payments from Abbott as spelled out in the development and commercialization agreement.

Abbott has exclusive worldwide commercialization rights for the SurVeil DCB. Surmodics will manufacture and supply the product and realize revenue from product sales to Abbott and a share of profits from Abbott’s third-party sales. 

Surmodics now will compete against Medtronic’s In.Pact Admiral DCB. The company said its device uses less paclitaxel than the In.Pact Admiral.

This is significant because there was a controversy using paclitaxel spurred on by a meta-analysis published in late 2018 showing an increased risk of death among patients who received a paclitaxel-coated balloon or paclitaxel-eluting stent.

After a two-day meeting of the Circulatory System Devices Panel, FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices.

The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies.

It should be noted that the tensions over paclitaxel devices eased in August 2019 when FDA provided some recommendations for doctors treating patients with paclitaxel balloons or stents.