CyndRx, LLC Receives Full FDA Approval of Investigational Device Exemption (IDE) to Initiate a U.S. Pivotal Trial for the AbsorbaSeal™ 5.6.7F Vascular Closure Device
The AbsorbaSeal™ 5.6.7F Vascular Closure Device is designed to remove the complexity and variability of vascular closure while allowing natural vessel healing.
Photo: AbsorbaSeal™ 5.6.7F Vascular Closure Device
CyndRx, LLC, a medical device company focused on improving percutaneous vascular closure, announces approval from the U.S. Food and Drug Administration (FDA) that the company has provided sufficient data to support initiation of an investigational device exemption (IDE) to evaluate the safety and effectiveness of the AbsorbaSeal™ 5.6.7F vascular closure device for closing femoral punctures during catheterization procedures.
With full IDE approval, CyndRx will conduct a new pivotal trial titled Study to Evaluate Time to Hemostasis of AbsorbaSeal: A Prospective, Multi-Center, Single Arm, Non-Randomized Study – The “SEAL TO HEAL” trial. In July 2021, CyndRx completed two pre-CE Mark trials evaluating AbsorbaSeal™ 5.6.7F in highly comorbid, 100% interventional patient populations, with strong clinical outcomes.
“The CyndRx team and our partners are delighted the FDA has granted this IDE allowing us to initiate a pivotal study in the U.S.,” said Dr John Shipp, CEO of CyndRx. “AbsorbaSeal is an innovative and intuitive platform of vascular closure devices with tremendous potential to improve the clinical outcomes and quality of life of catheterization patients while allowing the patients’ target vessels to heal naturally without chronic implants or a foreign body inflammatory response. We anticipate enrolling the first patient into the trial in the next few months.”
The multi-center trial will enroll 220 patients with 5-, 6-, or 7-French vascular punctures. Outcome measures will evaluate safety via major and minor closure-related complications, effectiveness via time to hemostasis as well as time to ambulation, time to discharge, device and procedural success, and the trial will include a core-lab evaluated duplex ultrasound sub-study.
Dr Ross Milner, Principal Investigator for the SEAL TO HEAL trial and Professor of Surgery, Section of Vascular Surgery and Endovascular Therapy, The University of Chicago Medical & Biological Sciences, stated “The AbsorbaSeal platform shows tremendous promise in improving the current state of vascular closure. Understanding the device’s impressive clinical outcomes and low learning curve/ease-of-use, combined with the benefit of natural vessel healing, I’m excited to lead the U.S. IDE clinical trial to ultimately bring this technology to market.”
The AbsorbaSeal™ 5.6.7F Vascular Closure Device is an investigational device and is not available for commercial use in any geography. You can learn more about the AbsorbaSeal™ platform of Vascular Closure Devices at www.cyndrx.com
Source: Company Press Release