Cordis-X Advances FASTEN Trial for Ladera Large Bore Closure System

An investigational, suture-based large bore closure device intended to deliver fast and reliable vascular closure

MENLO PARK, Calif., Oct. 23, 2025 /PRNewswire/ -- Cordis-X today announced that it has enrolled the first 25 patients in the FASTEN trial in pursuit of CE mark for Ladera Medical's investigational Large Bore Closure System, the first dedicated, built-for-purpose, suture-based large bore closure device that offers both pre-close and post-close optionality. The prospective, multi-center study aims to demonstrate the safety and performance of the system in achieving hemostasis after percutaneous catheterization with 10–24F introducer sheaths. By closing the femoral artery with a single device, the system is designed to deliver fast, reliable, and safe vascular closure.

Dr. Jeremy Durack, Cordis-X Chief Medical Officer, said, "The Cordis-X engine is delivering a pipeline of products focused on clinically impactful issues in cardiovascular care. The Ladera Large Bore Closure System is a next-generation large bore closure device that will further establish Cordis as a global leader in vascular access and closure solutions."

The Ladera Large Bore Closure System is the result of a partnership between Cordis and the Cordis-X accelerator. This unique business model identifies and advances differentiated technologies with the potential to expand the Cordis portfolio with innovative and clinically compelling solutions that respond to unmet needs in cardiovascular health. Cordis-X leverages the experience, expertise, and ecosystem of Ajax Health, with development partners like Inventure Group, to build on Cordis's strengths in R&D and commercialization and accelerate the technical development, regulatory approval, and clinical adoption of these products, which Cordis then has the right to purchase.

Duke Rohlen, CEO of both Cordis-X and Ajax Health, said, "The successful development of the Ladera Large Bore Closure System highlights the power of the Ajax model. Our collaboration with Cordis is bringing a much-needed solution to the market with greater speed and capital efficiency than can commonly be accomplished through internal development or a pure venture funding model."

As Cordis-X and Ladera advance with the FASTEN trial, Cordis remains committed to innovation and is closely engaged with the progress being made. Together, Cordis and Cordis-X are positioned to deliver a revolutionary business model and transformative value for patients, clinicians, and the broader healthcare community.

About Cordis-X

Cordis-X, an independent innovation accelerator based in Menlo Park, California, provides a streamlined model of medical device innovation built for speed, agility, and value maximization. Through its relationships with Ajax Health and Cordis, Cordis-X is able to quickly identify, evaluate, develop, and invest in emerging technologies that can expand the depth, breadth, and impact of the Cordis product portfolio.

About Ajax Health

Ajax Health is a medical device-focused private equity firm based in Menlo Park, California. The Ajax team draws on decades of experience as investors, operators, and entrepreneurs to deploy scaled capital and drive growth for the companies it partners with and acquires.

Media contact
Will Kynes
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SOURCE Cordis-X