Dive Brief:

• Surmodics said Monday it received a CE mark for a paclitaxel-coated balloon meant to treat peripheral artery disease.
• Abbott gained exclusive worldwide commercialization rights for the device, called SurVeil, via a February 2018 agreement with Surmodics. The CE mark milestone triggers a $10.8 million payment from Abbott to Surmodics.
• Surmodics plans to file a PMA submission for the device with FDA sometime during fiscal year 2021, which for the Minnesota-based medtech begins in October, but faces a hangup in obtaining all necessary data, as COVID-19 has challenged 12-month follow-up with certain clinical trial patients.

Dive Insight:

Drug-coated balloons have emerged as an important treatment option for some patients with peripheral artery disease (PAD), which in the U.S. alone may affect up to 12 million people. But scrutiny by clinical researchers and ultimately the FDA over whether devices using the drug paclitaxel actually result in higher-than-expected mortality rates cast a cloud over the class of devices.

One of the devices affected by that scrutiny is Medtronic's IN.PACT Admiral balloon. Surmodics' pivotal trial for SurVeil pits the device head to head with Medtronic's. The company's 446-patient TRANSCEND trial is comparing SurVeil for treating PAD in the upper leg to Medtronic's IN.PACT Admiral. Surmodics hopes data from that trial will support premarket approval for the device in the U.S.

As for European approval, Surmodics did not specify in Monday's announcement how it would move forward with product rollout. However, CEO Gary Maharaj on the company's late April earnings called Europe "a difficult market right now" in light of COVID-19, and also referenced the lingering debate on the safety of paclitaxel-coated devices.

Needham analysts in a Monday research note said they expect modest revenue in Europe at least until the TRANSCEND trial is completed. "We expect initial European SurVeil sales to be limited due to the shrunken DCB market (resulting from the concerns over potential paclitaxel related long-term mortality) and the lack of randomized controlled clinical trial data," the analysts wrote.

Through the Abbott agreement, Surmodics received a $25 million sum upfront, and $10 million when it completed patient enrollment last August for a clinical trial of the device. In addition to the $10.8 million it's receiving as a result of CE mark attainment, Surmodics said Monday it could earn up to $45 million more for future product milestones.

The partnership calls for Surmodics to manufacture and supply the product for clinical and commercial distribution, and says the smaller company will receive revenue from initial sales to Abbott and a share of profits from third-party sales. Surmodics declined to estimate revenue from the product for the next few months.

The more than 2-year-old agreement also gave Abbott options to negotiate agreements for Surmodics' below-the-knee and arteriovenous fistula drug-coated balloon products, the companies said at the time. One of those products is Surmodics' Sundance balloon, a sirolimus-eluting device meant for patients with critical limb ischemia and infrapopliteal arterial disease that gained breakthrough device status from FDA last October.