Medcura, Inc., a commercial-stage medical device company, published the results of a peer-reviewed clinical study at the University of Chicago in this month’s Cardiovascular Catheterization and Interventions (CCI).
This first-in-human study evaluated the clinical use of the Company’s FDA cleared R³ device for radial closure after routine angiography. Fifty consecutive subjects undergoing a diagnostic catheter-based cardiac procedure were enrolled in the study, where the Medcura device was used to enhance radial closure. The R³ device facilitated hemostasis, on average, in 41 minutes while causing no adverse events defined as clinically arterial occlusions, re-bleeding, re-admission, cutaneous discomfort or inflammation, or meaningful hematomas either on the day of the procedure or after follow-ups at 7 and 30 days. The study also required the use of post-procedural ultrasound to confirm that 100% of the enrolled subjects had full radial artery patency prior to a same-day discharge. The current standard of care used for radial closure are either pneumatically or mechanically actuated wristbands that use compression to achieve arterial closure. Comparing the current study, the time to hemostasis reported when using these wristbands is over 2 hours see with adverse event rates of up to 14%.
Dr. Sandeep Nathan, Medical Director of the Cardiac Intensive Care Unit, Co-Director of the Cardiac Catheterization Laboratory at the University of Chicago and Principal Investigator of the first-in-human study, said: “Achieving predictable, rapid hemostasis with preservation of radial patency remains a challenge. Medcura’s R³ device can provide a simple, elegant solution that will reduce recovery time and should improve workflow efficiencies. I’m pleased with both the hemostatic performance and the positive patient outcomes attributed to using this advanced materials approach. The almost “Velcro-like” removal without clot disruption and slight integration of some of the R³s material into the clot provided an easy-to-use process and durable seal.”
Reported analysis suggests that reducing the time to hemostasis after routine angiography is one of the most important factors that impact the total procedural cost. In combination with improved patient outcomes more rapid hemostasis can reduce the time to discharge enhancing patient satisfaction.