Medical Ingenuities’ PH Band System for Radial Hemostasis Introduced With Initial Cases

March 9, 2022—Medical Ingenuities announced the market introduction of the company’s PH Band system, which is cleared by the FDA to close the arteriotomy of a radial artery after a percutaneous coronary intervention (PCI) procedure and is designed to establish and maintain patent hemostasis before the patient is discharged from the hospital.

Medical Ingenuities reported that cardiologist Vivek V. Kumar, DO, completed the first four commercial radial cases using the PH Band system in February 2022, at Lakewood Ranch Medical Center in Lakewood Ranch, Florida. All cases were successful and demonstrated the benefits of the PH Band, stated the company.

“We are excited for the introduction of the PH Band system into our lab,” commented Dr. Kumar in the company’s press release. “Our initial experiences confirmed patent hemostasis with a simple application, a reduction in compression time, and a predictable time for healing of the access site.” Additionally, the recovery room nurses noted the simplicity of the PH Band system and the elimination of deflation adjustments.

Jimmy Kerrigan, MD, an interventional cardiologist at Ascension Saint Thomas Heart in Nashville, Tennessee, commented in the Medical Ingenuities press release, “The biggest problem with radial closure today is that we are just guessing that we are achieving patent hemostasis.”

Medical Ingenuities stated that the PH Band system provides an audible signal confirming the moment that patent hemostasis is achieved. This signal provides a customized compression at the arteriotomy, the lowest amount of pressure to ensure hemostasis, while maintaining proper blood flow through the radial artery.

Achieving patent hemostasis post-radial closure allows the coagulation process to begin immediately, leading to a faster healing process and eliminating multiple adjustments. The device meets Society for Cardiovascular Angiography and Interventions guidelines for achieving patent hemostasis, noted the company.