Cordis-X Advances the FASTEN Trial for Innovative Closure System
A groundbreaking, suture-based large bore closure device providing swift and dependable vascular closure.
Cordis-X has made significant strides by enrolling the initial 25 patients in its FASTEN trial, which is aimed at securing CE mark approval for the Ladera Medical's Large Bore Closure System. This device is pioneering in the field, being the first dedicated system utilizing a suture-based approach to efficiently manage vascular closure, offering both pre and post-closure options. This multi-center trial seeks to evaluate the safety and efficacy of the device for achieving hemostasis following catheterization with 10–24F introducer sheaths. It aims to close the femoral artery using a single device, accelerating and enhancing the reliability of vascular closure procedures.
Dr. Jeremy Durack, Chief Medical Officer at Cordis-X, stated, "The Cordis-X engine is pushing forward a pipeline of products that address significant needs in cardiovascular care. The Ladera Large Bore Closure System represents a new era for us and strengthens Cordis's position as a leader in the market for vascular access and closure solutions."
The Ladera Large Bore Closure System has been developed through a collaborative effort between Cordis and the Cordis-X accelerator. This innovative business model is designed to identify and advance differentiated technologies that expand Cordis's product line with impactful clinical solutions aimed at addressing unmet needs in cardiovascular health. Cordis-X capitalizes on the collective expertise and resources offered by Ajax Health and development partners like Inventure Group, which help to bolster Cordis's strengths in research, development, and comprehensive commercialization strategies, thus expediting the technical development, regulatory processes, and clinical integration of these new products.
Duke Rohlen, CEO of Cordis-X and Ajax Health, emphasized the importance of collaboration, saying, "The successful creation of the Ladera Large Bore Closure System demonstrates the efficacy of our model. Teaming up with Cordis enables us to deliver essential solutions to the market swiftly and with effective use of capital, rather than solely relying on internal development processes or traditional funding approaches."
As the teams at Cordis-X and Ladera continue to progress through the FASTEN trial, Cordis maintains its strong commitment to innovation, closely monitoring the developments and advancements achieved. This partnership is expected to create a new business model that promises transformative benefits for patients, healthcare professionals, and the broader medical community.
About Cordis-X
Cordis-X, an independent innovation accelerator situated in Menlo Park, California, embodies a diluted approach to medical device innovation, emphasizing speed, adaptability, and maximizing value. Through its strategic affiliations with Ajax Health and Cordis, Cordis-X swiftly identifies, assesses, develops, and invests in groundbreaking technologies that can broaden and enhance the impact of the Cordis product lineup.
About Ajax Health
Ajax Health specializes as a medical device-driven private equity firm located in Menlo Park, California. The Ajax team leverages extensive experience in investment, operations, and entrepreneurship to deploy substantial capital and foster growth for the entities they partner with and acquire.
Frequently Asked Questions
What is the purpose of the FASTEN trial?
The FASTEN trial aims to demonstrate the safety and performance of the Ladera Large Bore Closure System in achieving effective vascular closure after catheterization.
What does the Ladera Large Bore Closure System do?
This system is designed for efficiently closing the femoral artery using a suture-based approach to enhance vascular closure processes.
Who is leading the development of the Ladera Large Bore Closure System?
The development is a collaborative effort by Cordis and the Cordis-X accelerator.
What role does Ajax Health play in this initiative?
Ajax Health provides essential expertise and resources, enhancing Cordis's capabilities in research, development, and commercialization of innovative healthcare solutions.
How does the Ladera system improve patient care?
It delivers fast, reliable vascular closure, addressing significant needs in cardiovascular procedures and enhancing overall patient outcomes.
