Medical Ingenuities today received FDA 510(k) clearance for its radial artery occlusion device called PH Band.
PH Band provides real-time feedback to medical personnel monitoring radial artery patency to help prevent radial artery occlusion. It can be used in conjunction with a micro Doppler Probe to achieve patent hemostasis after a minimally invasive cardiac to vascular procedure.
“Worldwide, interventional cardiologists have been looking for a quick and simple way to achieve patent hemostasis in an effort to reduce complication rates and standardize patient recovery after accessing the radial artery. The PH Band will provide the interventional cardiologist new and vital information to properly complete a more effective radial artery closure. This outcome will, in turn, support their goal to reduce overall complications and healthcare costs and in turn increase patient satisfaction,” founder and CEO Chip Corrigan said in a news release.
PH Band provides real-time audible and visual feedback to clinicians to assist them in achieving patent hemostasis. The feedback confirms the paper application of pressure to attain hemostasis while also ensuring the patency of the radial artery.
“The paradigm shift from default femoral access to radial access over the last decade has truly been a win-win in terms of both improved safety outcomes and patient comfort. However, as with many steps forward, there is a small price to be paid, and radial access is no exception. The not so uncommon complication of radial artery occlusion is probably best mitigated by a combination of pharmacotherapy and patent hemostasis. The PH Band is uniquely poised to deliver on all fronts with the potential to methodically reduce occlusion rates; reduce bleeding, eliminate variability, and minimize valuable nursing resources,” said Paul Grunenwald, chairman of cardiology at AMITA Alexian Brothers Medical Center in Elk Grove, Ill.
The company said it plans to begin marketing the PH Band in early January to some hospitals across the country.