Dive Brief:

• FDA awarded breakthrough status to Minnesota medtech Surmodics' sirolimus-coated balloon catheter, the company said Tuesday.

• Surmodics is developing the device for use in patients with critical limb ischemia (CLI) and infrapopliteal arterial disease, cardiovascular conditions that can lead to amputation and death.

• The device, Sundance, is designed to improve outcomes by delivering sirolimus to inhibit the proliferation of cells, thereby stopping the artery from narrowing again after surgery.

Dive Insight:

Infrapopliteal arterial disease affects blood vessels below the knee and is the leading cause of critical limb ischemia (CLI). Once a patient has CLI, their prospects deteriorate. Around 90% of all amputations globally are linked to CLI and the disease is associated with a 24% mortality risk over the first year after diagnosis. 

Companies including Abbott and Cordis have tested stents that elute sirolimus and everolimus in CLI, generating evidence that their interventions are more effective than plain balloon angioplasty and bare-metal devices.

Surmodics is developing Sundance to address a continued need for devices that reduce the rate of amputation and death. The device is coated with a proprietary sirolimus formulation, the same anti-inflammatory and anti-proliferative compound found in other drug-eluting products.

The company completed the preclinical work needed to finalize dosing and formulation earlier this year, setting it up to file to run a first-in-human trial. Details of a 35-subject study of the device went up on ClinicalTrials.gov late last month but enrollment hasn't yet begun.  

"Realistically, it will take a couple of quarters before we can even contemplate starting the trial because we're not in control of the regulators and which geography they allow us to start this in and then the trial's start-up time," Surmodics CEO Gary Maharaj said on a quarterly results conference call with investors in July.

Surmodics plans to start the trial in February and has penciled in a January 2021 primary completion date. As the device advances toward the market, Surmodics stands to benefit from the additional regulatory exchanges and expedited review FDA provides through the Breakthrough Devices Program.