#USA #Menlo Park #Cordis-X #Ladera Medical #FASTEN Trial

Cordis-X Initiates the FASTEN Trial for the Ladera Large Bore Closure System

Cordis-X, an innovation accelerator based in Menlo Park, California, is making significant strides in the medical device sector. Recently, the company announced the enrollment of the first 25 patients in its FASTEN trial, which is crucial for acquiring the CE mark for the Ladera Medical's Large Bore Closure System. This investigational device—a suture-based solution—aims to redefine vascular closure methods after percutaneous catheterization using introducer sheaths ranging from 10 to 24F.

The Ladera Large Bore Closure System represents a robust advancement in vascular access technology. As the first of its kind explicitly designed for large bore closures, it offers both pre-close and post-close options. This feature is anticipated to enhance the efficiency and reliability of vascular closure procedures, ensuring rapid hemostasis—an essential aspect following critical catheter insertions.

Dr. Jeremy Durack, Chief Medical Officer of Cordis-X, articulated the importance of this trial, stating, "The Cordis-X engine is delivering a pipeline of products focused on clinically impactful issues in cardiovascular care." The introduction of the Ladera closure device is expected to solidify Cordis's position as a leading entity in the burgeoning field of vascular access and closure solutions.

The conceptualization and production of the Ladera system stem from a collaboration between Cordis and Cordis-X. This partnership is distinct in its approach, leveraging advanced technologies to address pressing needs in cardiovascular health. Moreover, Cordis-X collaborates with Ajax Health and works closely with development partners like Inventure Group. This network is instrumental in fast-tracking research and development (R&D), regulatory approvals, and the actual clinical adoption of groundbreaking medical devices.

Duke Rohlen, the CEO of both Cordis-X and Ajax Health, underscored the benefits of this partnership model. He remarked, "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 continues to progress through the FASTEN trial, the team remains committed to innovation in vascular solutions. The collaboration showcases a promising future for both patients and healthcare providers, as innovative medical devices can significantly impact patient outcomes and accessibility to essential procedures.

This dedication to advancing cardiovascular technologies positions both Cordis-X and Cordis to reshape how medical professionals approach vascular closures—a key element in numerous medical interventions.

Overall, the Ladera Large Bore Closure System is indicative of an evolution in how such devices are conceptualized and brought to market. By addressing unmet needs and offering cutting-edge solutions, the collaboration between Cordis-X and its partners showcases a path forward for medical device innovation.

In conclusion, the initiation of the FASTEN trial marks a pivotal moment not just for Cordis and Cordis-X but also for the broader healthcare community as they work to deliver more effective health solutions to clinicians and patients alike.