MDR certification confirms the company’s commitment of ensuring that their innovative new products meet or exceed these rigorous new standards.
Nashville, Tennessee – (OCT 13, 2022) – VESALIO announces the EU MDR certification of its product lines significantly ahead of the May 2023 deadline. This important milestone marks the third in a series of recent regulatory achievements along with the CE marking of NeVa NET™, VESALIO’s new, flagship neuro-thrombectomy device containing a unique integrated distal filter technology and the FDA HDE approval of NeVa VS™, indicated for the adjunctive treatment of aSAH-induced cerebral vasospasm. NeVa VS is the first medical device approved in the U.S. for this indication.
In the past several years, regulations for medical device manufacturers have become progressively complex and demanding. In Europe, the transition from MDD (Medical Device Directives) to MDR (Medical Device Regulations) has brought increased quality and regulatory demands, including additional clinical evidence of safety and efficacy. “This new reality affects both the approval and post-approval processes, introducing stricter requirements for post-market clinical follow-ups,” stated Gustavo Prado, VP of Development and Operations. “This certification, along with our other recent regulatory milestones, showcases the focus and diligence of our quality and regulatory teams.”
Stringent MDR regulations have forced many medical device companies to make difficult decisions to discontinue thousands of product SKUs in the European marketplace rather than comply with new quality standards. In this challenging environment, Vesalio proudly reconfirms its dedication to being a global organization. “We are committed to our commercial partners working alongside us as we expand our product portfolio in Europe, MEA, LATAM and Asia-Pacific regions while continuing to invest in further geographic expansion,” said William von Brendel, VP of International Business.
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians with superior technology designed to improve clinical outcomes. Vesalio’s proprietary NeVa™ and enVast™ platforms are designed to consistently achieve first-pass recanalization in stroke and STEMI, respectively, by effectively removing all types of neurovascular clots from a patient’s anatomy. For more information, visit vesalio.com.