We are dedicated to providing superior patient outcomes
Our Clinical Trials and Results
OPEN-Radial Trial (2020)
A randomized, 250-patient trial has proven that the performance of the VASOBand is superior when compared to the performance of the TR Band (currently the leading brand). The double-balloon VASOBand has been shown to significantly decrease the rate of radial artery occlusion in a randomized trial when compared to the single-balloon hemostasis TR Band. This study shows that the VASOBand has a significantly higher percentage achievement of patent hemostasis – and without intense, repetitive patency monitoring by the care team.
Larger-bore transradial access is usually associated with higher rates of radial artery occlusion. However, the VASOBand is very effective in reducing the rate of radial artery occlusion. Use of the VASOBand in larger-bore radial access (such as 7 French access), is being evaluated in another randomized, controlled trial.
Shorter compression times have been associated with lower rates of radial artery occlusion, although a reduction in compression time less than 2 hours has also been associated with higher rates of rebound bleeding. However, this is not the case not with the VASOBand, which has a much lower rate of rebound bleeding compared to the TR Band.
Promoting Patent Hemostasis
97% probability of achieving patent hemostasis with VASOBand versus 75% with TR Band
6.4x reduction of Radial Artery Occlusion using VASOBand compared to using TR Band
The VASOBand is the only device capable of performing concomitant ipsilateral ulnar artery compression Radial artery hemostasis using ipsilateral ulnar artery compression for the initial 60 minutes is associated with a higher probability of achieving patent hemostasis and with higher radial artery patency at discharge compared with traditional radial-only compression (TR Band) in patients undergoing diagnostic cardiac catheterization using transradial access (TRA). 1
Significantly lower rate of RAO
“The VasoBand is also associated with a significantly lower rate of RAO at the time of discharge from the cardiac catheterization laboratory compared with the conventional patent hemostasis protocol.”
Achieving Patent Hemostasis
“…VASOBand is associated with a higher probability of achieving patent hemostasis and with higher radial artery patency at discharge compared with TR Band in patients undergoing diagnostic cardiac catheterization using TRA.”
Health Economics & Patient Benefits
“…Approaches that require frequent monitoring are likely less desirable for the cardiac catheterization care team due to scarcity of skilled manpower and related costs.”
Seamless Clinical Integration
“These results were achieved without the need for frequent monitoring of radial artery patency and adjustment of hemostatic compression pressure, as advised by the typical patent hemostasis protocol.”
PROPHET II Trial (2017)
Reducing Incidence of RAO
The VASOBand is the only compression device that reduces the incidence of radial artery occlusion (RAO) using ipsilateral prophylactic ulnar artery compression while compressing the radial artery for hemostasis after transradial access (TRA). 2
References:
Patel GA, Patel B, Shah, SC et al. Randomized COmparison of Isolated Radial Artery ComPrEssioN versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: OPEN-Radial Trial. J Inv Cardiol 2020.
Pancholy, S. B., Bernat, I., Bertrand, O. F., & Patel, T. M. (2017). Prevention of radial artery occlusion after transradial catheterization: the PROPHET-II randomized trial. JACC: Cardiovascular Interventions, 9(19), 1992-1999.