CyndRx, LLC Announces Completion of Enrollment in the AbsorbaSeal™ Vascular Closure Device CE Mark Trial
CyndRx, LLC, a medical device company focused on improving vascular closure, announced completion of enrollment in the AbsorbaSeal™ 5.6.7F CE Mark trial. This trial enrolled a total of 50 subjects across four Investigators in Belgium institutions.
“Given the ongoing global COVID pandemic and the associated challenges conducting a remote/virtual regulatory trial, we are very pleased with the rapid and successful completion of enrollment in the AbsorbaSeal™ 5.6.7F CE Mark study. This is another successful milestone in the clinical program for the AbsorbaSeal™ platform of vascular closure devices (VCDs),” said Dr John Shipp, Chief Executive Officer. “We are thankful for the strong partnership between CyndRx, trial Investigators, and everyone involved helping us achieve this important goal,” he added.
Dr Koen Deloose – Head of the Department of Vascular Surgery at AZ Sint-Blasius Hospital, Dendermonde, Belgium and Principal Investigator of the trial commented, “Given the intuitive design and ease of use of AbsorbaSeal™, we have realized excellent procedural and clinical success in a uniquely challenging patient population; we enrolled 100% interventional cases in this trial. Acutely, device performance was outstanding and follow-up evaluations of implanted subjects continue to demonstrate the clinical advantages of the AbsorbaSeal™ platform.”
The AbsorbaSeal™ 5.6.7F VCD is part of the overall AbsorbaSeal™ VCD platform, offering the easiest to use, most rapidly deployed VCD with a minimal learning curve. The device seals and allows vessel healing without chronic or permanent implant materials while improving the economic value of vascular closure devices.
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