Cordis-X’s FASTEN Trial of Ladera Large-Bore Closure System Advances Enrollment

October 24, 2025—Cordis-X announced that it has enrolled the first 25 patients in the FASTEN trial in pursuit of CE Mark approval for Ladera Medical’s investigational large-bore closure system.

According to Cordis-X, the dedicated, built-for-purpose, suture-based, large-bore closure device is designed to provide both preclose and postclose options. The system is intended to deliver fast, reliable, and safe vascular closure by closing the femoral artery with a single device.

The prospective, multicenter FASTEN study aims to demonstrate the safety and performance of the system in achieving hemostasis after percutaneous catheterization with 10-F to 24-F introducer sheaths, stated Cordis-X.

As noted in the press release, the Ladera large-bore closure system is the result of a partnership between Cordis and the Cordis-X accelerator, a business model that 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.