CyndRx, LLC has initiated training for sites that will participate in the multi-center trial of the AbsorbaSeal™ 5.6.7F Vascular Closure Device (VCD) to support CE Mark approval.

CyndRx, LLC announced it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the AbsorbaSeal™ 5.6.7F Vascular Closure Device. The CE Mark trial, which will include study centers in Belgium, seeks to enroll 50 subjects who will be followed for 30 days.

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.

“We have been very encouraged by the clinical results to date with our AbsorbaSeal™ 5.6.7F Vascular Closure Device,” said John Shipp, PhD, Chief Executive Officer of CyndRx, LLC. “We look forward to initiating our CE Mark study and are excited to be one step closer to having AbsorbaSeal™ available for clinical use throughout the European Union.” The prospective, multi-center CE Mark trial will enroll subjects across 3 clinical sites within Belgium. Time to Hemostasis (TTH), Device Success, Procedure Success, and Closure-related Major and Minor Complications will be assessed.

“The global catheter-based cardiovascular therapies market is large and growing. Through our market intelligence investigations it became apparent there are several unmet needs with currently marketed vascular closure devices, namely reducing the learning curve, decreasing procedural time required to deliver/deploy a VCD, and sealing the arteriotomy with materials that truly allow the vessel to heal without chronic implants or significant scarring. The AbsorbaSeal™ VCD platform of devices is designed to achieve these goals of both clinical and economic value,” said Denny Lawson, Chief Commercialization Officer of CyndRx, LLC.

The AbsorbaSeal™ 5.6.7F Vascular Closure Device is currently an investigational device. You can learn more about the AbsorbaSeal™ platform of Vascular Closure Devices at cyndrx.com.

Source: Company Press Release