Medcura publishes successful results from clinical study
Wednesday, April 7, 2021
Demonstrating rapid hemorrhage control and improved patient outcomes
RIVERDALE, Md., April 7, 2021 /PRNewswire/ -- Medcura, Inc., a commercial-stage medical device company, announced today that it has 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 (50) 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 seven (7) and thirty (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 do not use hemostatic material, but instead use only compression, to achieve arterial closure. In comparison to the current study, the time to hemostasis reported when using these wristbands is over 2 hours see https://pubmed.ncbi.nlm.nih.gov/29769165/ with adverse event rates of up to 14% see https://pubmed.ncbi.nlm.nih.gov/22230148/.