CyndRx, LLC Enrolls First Patients in the AbsorbaSeal™ Vascular Closure Device CE Mark Trial
Study to Support European Approval of the AbsorbaSeal™ 5.6.7F Vascular Closure Device (VCD)
CyndRx, LLC, a medical device company focused on improving vascular closure, announced enrollment of the first patients in its prospective, multi-center trial in Belgium. The 50-patient study will evaluate the safety and efficacy of the AbsorbaSeal™ 5.6.7F VCD in support of its CE Mark submission.
The first patient was enrolled by Dr Koen Deloose – Head of the Department of Vascular Surgery at AZ Sint-Blasius Hospital, Dendermonde, Belgium and Principal Investigator of the trial. Dr Deloose commented, “Vascular closure is a critical driver of overall success for catheter-based procedures. The AbsorbaSeal™ device has performed excellently so far and we look forward to enrolling the full study cohort.” Dr Lieven Maene – Vascular Surgeon at Onze-Lieve-Vrouw Hospital, Aalst, Belgium, has enrolled additional patients and added, “AbsorbaSeal™ offers the most straightforward procedural technique with rapid hemostasis, key attributes for a successful vascular closure device.”
Enrolling patients at up to three Belgium sites, the CE Mark trial is designed to evaluate the safety and efficacy of the AbsorbaSeal™ 5.6.7F VCD in sealing percutaneous femoral artery access sites following diagnostic or interventional vascular procedures, from both a retrograde and antegrade approach.
“The CE Mark trial for AbsorbaSeal™ 5.6.7F VCD builds on the insights and successes of our pre-regulatory studies,” stated Randy Bassett, PhD, Chief Science Officer of CyndRx, LLC. “It is the next phase in our comprehensive program to bring a biologically friendly, procedurally efficient, and economically valuable VCD to market.”
The AbsorbaSeal™ 5.6.7F VCD is part of the overall AbsorbaSeal™ VCD platform that intends to offer the easiest to use VCD with a completely absorbable and biologically friendly sealing mechanism allowing the vessel to heal with minimal inflammatory response and no chronic implant materials. The device is intended to provide safe, effective, and rapid hemostasis of an arteriotomy while significantly reducing time of delivery/deployment.
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