Solaris Endovascular, Inc. Launched in the United States

November 20, 2024—Solaris Endovascular, Inc. recently announced the formation of the company, which will develop solutions for dialysis access in end-stage kidney disease (ESKD) and the treatment of peripheral artery disease (PAD). Its technologies are intended to treat and extend the patency of dialysis access fistulae, grafts, and peripheral arteries.

According to Solaris Endovascular, its flagship product is the Solaris SX vascular stent graft. Solaris SX employs an electrospinning polytetrafluoroethylene (PTFE) impermeable membrane that prevents tissue ingrowth, maximizes patency, and reduces restenosis. This thin, multidirectional PTFE membrane encapsulates a nitinol stent that provides flexibility, radial strength, and crush resistance for optimal blood flow, stated the company.

Marco Costa, MD, is Chairman and Chief Medical & Scientific Officer at Solaris Endovascular.

“Bringing this innovative technology to the United States is a major step forward in improving the lives of patients,” stated Dr. Costa in the company’s press release. “Solaris Endovascular’s advanced covered stent platforms will not only reduce the burden of repeated interventions but will also dramatically enhance the quality of life and life expectancy for those who suffer from these debilitating conditions.”

Solaris Endovascular advised that it is enrolling patients in clinical trials for its Solaris DE drug-eluting vascular stent graft. Solaris DE, which incorporates sirolimus, is intended to address edge stenosis. As noted in the press release, sirolimus revolutionized the treatment of coronary artery disease with the virtual elimination of restenosis—from 30% to 3%. “We expect Solaris DE to deliver similar transformative results to patients with ESKD and PAD,” stated Dr. Costa.

The company’s CEO Randy Hubbell added, “Solaris Endovascular represents a rare opportunity to start a new company that is revenue producing from the beginning; has a decade-plus manufacturing expertise in stents, stent grafts, and endovascular drug delivery; and [is] a proven product supported by clinical studies in multiple markets before entering the United States. Our platform addresses a significant unmet need in both dialysis access and PAD, offering life-changing solutions for patients while setting a new standard in endovascular care.”

In comments to Endovascular Today, Solaris Endovascular stated that it was formed in the summer of 2024 and acquired certain endovascular stent technologies from Scitech Medical, including the worldwide rights to the Solaris (SX and DE) technology. Scitech Medical is the original developers of the technology.

The Scitech Solaris SX device, which gained CE Mark approval in 2019 and is now sold in the European Union and other countries, will be registered by Solaris Endovascular in the United States, and the brand name will remain the same. The European sales will move to Solaris Endovascular in 2025, stated the company.

Both the Solaris SX and the Solaris DE will go through the FDA premarket approval process in the United States. Solaris Endovascular will submit an application for an FDA investigational device exemption for the Solaris SX clinical program in 2025. This will be followed by an IDE submission for Solaris DE, the company advised Endovascular Today.