Solaris Endovascular, Inc. Launches to Revolutionize Vascular Health Solutions Globally

Solaris Endovascular Inc

Solaris SX Flexibility

NEW ORLEANS, LA, UNITED STATES, November 13, 2024 /EINPresswire.com/ — Solaris Endovascular, Inc. Launching to Address Vascular Health Challenges Globally

Solaris Endovascular, Inc. proudly announces 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.

End-Stage Kidney Disease (ESKD) is a major health concern affecting approximately 10 million people worldwide with approximately 3 million people receiving kidney replacement therapy and relying on hemodialysis 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 reported that the global prevalence of peripheral artery disease (PAD) may be as high as 230 million people. PAD can progress from painful walking to critical limb ischemia, and many patients require revascularization procedures to restore blood flow, improve symptoms, or prevent amputations.

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 flagship Solaris(TM) SX Vascular Stent Graft employs the most advanced electrospinning PTFE impermeable membrane that prevents tissue ingrowth, maximizes 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. These features are already proven in global markets with more than 13,000 units sold to date. 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 United States is a major step forward in improving the lives of patients,” said Dr. Marco Costa, Chairman and Chief Medical & 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(TM) DE Drug-Eluting Vascular Stent Graft – that will address the remaining unmet need in covered stents: edge stenosis. Solaris DE incorporates Sirolimus, a powerful and safe anti-proliferative agent that 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,” said Dr. Costa.

CEO Randy Hubbell emphasized 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 U.S. 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 U.S. registration process, it is committed to driving meaningful improvements in patient outcomes, reducing hospital readmissions, and lowering overall healthcare costs.

About Solaris Endovascular, Inc.

Solaris Endovascular, Inc. is a growth stage US-based medical device company developing advanced endovascular solutions for patients suffering from dialysis access challenges and Peripheral Artery Disease. With a proven stent platform and innovative drug-eluting technology, led by seasoned executives with extensive experience in cardiovascular MedTech, Solaris Endovascular is uniquely positioned and committed to improving long-term patient outcomes and transforming vascular health.

For more information, please visit: [www.solarisendovascular.com]

Randy Hubbell
Solaris Endovascular, Inc.
[email protected]
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