The initial clinical experience included five implants in three patients, two of them, presenting with bilateral iliac aneurysms, achieving 100% technical success. All devices were successfully delivered and deployed as intended, with preservation of target vessels and no immediate device-related adverse events.
The milestone represents a significant step in the clinical validation of EndoHub, a proprietary platform based on the novel concept of multi-lumen connector stent-grafts. The technology was developed to address persistent limitations associated with current endovascular solutions, particularly in patients with challenging anatomy where treatment options remain restricted.
Despite major advances in endovascular aneurysm repair over the last two decades, a substantial number of patients continue to face anatomical limitations that complicate treatment planning and device selection. EndoHub was specifically designed to expand anatomical applicability while preserving procedural familiarity for physicians and compatibility with existing endovascular technologies.
“This milestone represents much more than the successful implantation of our devices,” said Henrique W. Luckmann, Chief Executive Officer of Archo Medical. “It provides the first clinical validation of a platform technology that has the potential to redefine how physicians approach complex aneurysm repair. Our objective has always been to develop solutions capable of expanding treatment options for patients while integrating seamlessly into current endovascular practice.”
The procedures were performed following approval by the Brazilian Health Regulatory Agency (ANVISA) and CONEP (national ethic committee). The study is part of Archo Medical’s broader clinical and regulatory strategy to generate evidence supporting future commercialization in Brazil and international markets.
“Moving from concept to clinical application is one of the most challenging transitions in medical device innovation,” said Prof. Pierre Galvagni Silveira, MD, PhD, vascular and endovascular surgeon, co-founder of Archo Medical, and inventor of the technology. “The successful treatment of these initial patients supports the feasibility of the platform and reinforces our belief that EndoHub may become a valuable addition to the therapeutic arsenal available for complex aneurysm repair.”
Archo Medical plans to continue patient follow-up, expand clinical evaluation, and pursue additional regulatory milestones as part of its global development strategy. The company believes the platform architecture may enable future applications beyond iliac aneurysms, supporting a broader vision of modular and adaptable endovascular solutions for increasingly complex aortic pathologies.
As the global market for endovascular aortic interventions continues to grow, driven by aging populations and increasing demand for minimally invasive therapies, Archo Medical is positioning itself as an emerging innovator in one of the most technically demanding segments of the medical device industry.
About Archo Medical
Archo Medical is a privately held cardiovascular medical technology company headquartered in Florianópolis, Brazil. The company develops innovative endovascular solutions focused on complex aortic disease. Its proprietary EndoHub™ platform introduces a novel multi-lumen connector architecture designed to expand treatment possibilities for patients with challenging anatomies while leveraging existing endovascular technologies and procedural workflows.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development, regulatory approval, commercialization, and potential clinical applications of the EndoHub platform. Actual results may differ materially from those expressed or implied by these statements.
Regulatory Notice
The EndoHub platform is currently investigational and is not approved for commercial sale in all jurisdictions. The clinical results described herein are based on an initial experience involving two patients and should not be interpreted as conclusive evidence of long-term safety or effectiveness.
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