CyndRx has begun enrollment in the SEAL TO HEAL U.S. IDE clinical trial to assess the safety and effectiveness of the AbsorbaSeal™ 5.6.7F Vascular Closure Device.
The AbsorbaSeal™ 5.6.7F vascular closure device is intended to remove the complexity and variability of vascular closure with a procedurally efficient delivery and deployment technique coupled with a bioabsorbable sealing mechanism meant to allow the target vessel to heal naturally without chronic materials or adverse inflammation.
Photo: AbsorbaSeal™ 5.6.7F Vascular Closure Device
CyndRx, a medical device company focused on improving percutaneous vascular closure, has started U.S. enrollment in the SEAL TO HEAL clinical trial to assess the safety and effectiveness of its new AbsorbaSeal™ 5.6.7F vascular closure device.
The SEAL TO HEAL trial is an Investigational Device Exemption trial to evaluate the fully bioabsorbable sealing mechanism for the closure of femoral artery punctures following catheter-based diagnostic and interventional procedures.
CyndRx President and Chief Science Officer Randy Bassett, PhD commented: “More than 10 million patients per year globally have catheter-based interventions and a high percentage of these patients will require future interventions. There’s limited runway in these femoral arteries and if we can successfully close these vessels after their primary procedures while allowing the vessel to heal naturally, we are setting these vasculopath patients up for procedural success not just today, but for their future catheter-based procedures as well.”
The first patients in the SEAL TO HEAL trial were treated at Inland Imaging in Spokane, Washington by Jayson Brower, MD and Christopher Zylak, MD. Ross Milner, MD, Chief, Section of Vascular Surgery and Endovascular Therapy at University of Chicago Medicine, serves as the SEAL TO HEAL trial Principal Investigator.
CyndRx plans to enroll 220 patients at multiple institutions throughout the U.S., including private, academic, and office based labs, across interventional cardiology, interventional radiology, and vascular surgery.
The SEAL TO HEAL trial builds upon the clinical successes from two pre-CE Mark trials in Europe, where strong and differentiating procedural success, clinical success, and follow-up outcomes were demonstrated.
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