Solaris Endovascular, Inc. has recently announced its formation to develop solutions for dialysis access and peripheral artery disease (PAD). Solaris Endovascular develops evidence-based technologies, intended to treat and extend the patency of dialysis access fistulae, grafts, and peripheral arteries to allow patients to lead healthier lives with fewer interventions.
According to a press release issued by the company, End-Stage Kidney Disease (ESKD) is a major health concern affecting approximately 10 million people worldwide, with approximately three million people receiving kidney replacement therapy and relying on haemodialysis to survive. Over 50% of these patients experience vascular access failures within the first year and are subjected to hospital admissions and repeated costly endovascular or surgical interventions to restore their lifeline to dialysis—this drastically impacts quality of life, treatment effectiveness and survival.
In April 2024, the American Heart Association (AHA) reported that the global prevalence of PAD may be as high as 230 million people. PAD can progress from painful walking to critical limb ischemia, and many patients require revascularisation procedures to restore blood flow, improve symptoms, or prevent amputations.
The press release also added that stent-grafts are emerging as the preferred minimally invasive treatment for these conditions and Solaris Endovascular is currently selling the latest generation of stent-grafts. The company’s flagship product, Solaris SX vascular stent graft, employs what they refer to as “the most advanced electrospinning polytetrafluoroethylene (PTFE) impermeable membrane” that prevents tissue ingrowth, maximises patency, and reduces restenosis. This thin, multi-directional PTFE membrane encapsulates a nitinol stent that provides flexibility, high radial strength, and crush resistance for optimal blood flow. The announcement states that these features are already proven in global markets, with more than 13,000 units sold to date. According to Solaris Endovascular, interventional and endovascular physicians worldwide have chosen Solaris SX for its trackability and precise pinpoint deployment, ensuring accurate placement.
“Bringing this innovative technology to the USA is a major step forward in improving the lives of patients,” said Marco Costa, chairman and chief medical and scientific officer at Solaris Endovascular Inc. “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.”
Looking ahead, Solaris Endovascular is already enrolling patients in clinical trials for the first of its kind Solaris DE drug-eluting vascular stent graft, which it hopes will address the remaining unmet need in covered stents: edge stenosis. Solaris DE incorporates sirolimus, a powerful and safe anti-proliferative agent that it states revolutionised 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,” said Costa.
Chief executive officer (CEO) Randy Hubbell emphasised the company’s unique position in the market: “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 a proven product supported by clinical studies in multiple markets before entering the USA. 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.”
As Solaris Endovascular prepares for the US registration process, it stated that it is committed to driving “meaningful improvements in patient outcomes, reducing hospital readmissions, and lowering overall healthcare costs”.
