CyndRx’s AbsorbaSeal 5.6.7F Vascular Closure Device Studied in SEAL TO HEAL IDE Trial in the United States

June 6, 2022—CyndRx, a company focused on percutaneous vascular closure devices, has started United States enrollment in the SEAL TO HEAL clinical trial to assess the safety and effectiveness of the company’s new AbsorbaSeal 5.6.7F vascular closure device. The first patients in the SEAL TO HEAL trial were treated by Jayson Brower, MD and Christopher Zylak, MD, at Inland Imaging in Spokane, Washington.

Ross Milner, MD, serves as the SEAL TO HEAL trial’s Principal Investigator. Dr. Milner is Chief, Section of Vascular Surgery and Endovascular Therapy at University of Chicago Medicine in Chicago, Illinois.

According to the company, the SEAL TO HEAL investigational device exemption (IDE) trial will evaluate the fully bioabsorbable sealing mechanism for the closure of femoral artery punctures after catheter-based diagnostic and interventional procedures. The trial plans to enroll 220 patients across interventional cardiology, interventional radiology, and vascular surgery at multiple institutions throughout the United States, including private, academic, and office-based labs.

The trial seeks to build upon two pre-CE Mark approval trials in Europe that demonstrated procedural success, clinical success, and follow-up outcomes.

The AbsorbaSeal 5.6.7F vascular closure device is an investigational device and is not available for commercial use in any geography, advised CyndRx.