FDA Clears Medical Ingenuities’ PH Band Radial Artery Occlusion Device

December 9, 2020—Medical Ingenuities’ radial artery occlusion device, PH Band, has received FDA 510(k) clearance. The company will begin marketing the PH Band in early January 2020 to select hospitals across the United States.

Medical Ingenuities is based in Wheaton, Illinois, and is a portfolio company of Genesis Innovation Group’s cultivate(MD) Capital Fund II LP, which is focused on investments into early-stage health care companies.

According to the announcement from Genesis Innovation Group, the PH Band system is used in conjunction with a micro Doppler probe to provide real-time audible and visual feedback to clinicians. The feedback will confirm the proper application of pressure to attain patent hemostasis after a minimally invasive cardiac or vascular procedure, while also ensuring the patency of the radial artery to prevent radial artery occlusion. The device aids in reducing nurse workload and occlusion-related complications and meets the Society for Cardiovascular Angiography Interventions’ recommendation that patent hemostasis techniques be used for radial closure, noted the company.

Paul J. Grunenwald, MD, Chairman of Cardiology at AMITA Alexian Brothers Medical Center in Elk Grove, Illinois, explained in the press release, “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.”