Cardiac Medical Devices Market to Expand with New Device that Decreases Hemostasis Period for Patients Undergoing Cardiac Catheterization

  • Analysis
  • 13-May-2021

Cardiac catheterization refers to a procedure performed to assess the heart or arteries for diagnosis and interventions of a patient. A popular method of achieving it is through the trans-radial approach. The approach requires the insertion of a catheter through the radial artery in the arm to the heart. Then, the hole made during the catheterization process is closed with the help of a compression device called a TRB (TR band). The problem arises with the standard protocol that states the band needs to be left on for no less than two hours after the procedure.
To reduce this problem, a research team has unveiled PFHP (Potassium Ferrate Hemostatic Patch). They have showcased that it can decrease the time to hemostasis for patients undergoing cardiac catheterization. This is groundbreaking progress for the Cardiac Medical Devices industry as the findings of this study bring forth a faster approach to remove the compression band used in the procedure. Further, it is entirely safe for use as well. 
The new study compared using the StatSeal device patch in contrast to using a TRB alone to reduce homeostasis after transitional access. The team enrolled 443 patients at three centers, along with 27.5% of them receiving PCI (Percutaneous Coronary Intervention).
The patients were randomly divided at a 1:1 ratio of getting the TRB alone or TRB plus potassium ferrate hemostatic patch. Both groups had a TRB deflation tried on then after 60 minutes post-procedure. The findings revealed that combined use of the patch is safer and faster in deflating the TRB. Moreover, the use of TRB plus PFHP also reduced rebleeding. 
Results showcase that the time taken to complete the TRB deflation was reduced when using PFHP compared to when TRB was used alone. Furthermore, minor rebleeding that required TRB reinflation was found to be more frequent without the PFHP. And the rate of hematomas developed was lower in those patients that belonged to the PFHP. Researchers also stated that the reduction in time to TRB deflation and complications was also present among PCI patients in the PFHP group.
Heparin dosing is used to decrease the risk of radial artery occlusion and was up to operator preference. In the study, 41% of the patients were given less than 5000 units of the side. This amount is lower than the current practice, which suggests that it may be okay to use lower doses for diagnostic catheterization initially to accelerate patient discharge and TR band deflation.  
The study is of great benefit to the Cardiac Medical Devices Industry as it challenged the standard of care applicable currently in terms of Cardiac catheterization and put forth a new approach that might help patients get discharged. 
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