CyndRx, LLC Finalizes CE Mark Trial with Strong Clinical Outcomes using AbsorbaSeal™ Vascular Closure Device
Photo: AbsorbaSeal™ 5.6.7F Vascular Closure Device
CyndRx, LLC, a medical device company focused on improving vascular closure, announced the finalization of the AbsorbaSeal™ 5.6.7F CE Mark Trial evaluating the safety and efficacy of this new polymer-based, biologically friendly vascular closure device (VCD). This trial enrolled a total of 50 subjects across four Investigators in Belgium institutions.
“Based on feedback from our high-volume VCD KOLs, the ideal VCD would be easy to use and intuitive, provide rapid and secure arterial hemostasis, and allow the vessel to heal without significant inflammation or chronic materials left behind,” said Denny Lawson, Chief Commercial Officer at CyndRx, LLC. “With final data from our CE Mark Trial, the average closure procedure time was 45 seconds, 100% of patients had instant arterial hemostasis, and all target vessels evaluated at discharge and 30-day follow-up were normal – no hematomas, false aneurysms, or other abnormalities – making this study a great success and demonstrating our design goals to advance the current offerings in vascular closure have been achieved in-line with those of top global KOLs,” he added.
Fifty (50) subjects were enrolled during the global COVID pandemic which led to an all-interventional, significantly comorbid cohort. Twenty percent (20%) of procedures were done with an antegrade approach. Device and procedural success were both 100% and the average pain scores at discharge and 30-day follow-up were < 1 on a 10-point scale. Through 30-day follow-up, there were no closure-related major or minor complications reported and no adverse events related to the device.
“Currently marketed VCDs require many procedural steps with a significant learning curve and as such are time consuming in the procedural room. Additionally, management of the access site after VCD deployment adds even greater resource burden to institutions and staff,” said Dr Randy Bassett, Chief Science Officer. “Data from the AbsorbaSeal™ 5.6.7F CE Mark Trial are very encouraging, requiring < 1 minute for the procedure and groin management combined. Moreover, the biologically friendly seal design allows natural vessel healing and sets these vasculopath patients up for success in future interventions. AbsorbaSeal™ 5.6.7F removes the complexity and variability of vascular closure and we look forward to initiating our U.S. trial soon.”
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 safely and securely seals a vessel puncture, allows natural vessel healing without clinically significant inflammation or chronic/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