The FDA has cleared a number of improvements on St Jude Medical‘s PressureWire Fractional Flow Reserve (FFR) measurement guidewire, including the new “Agile Tip” that helps navigate through difficult vasculature.
The device is available in wireless and wired models, Aeris and Certus respectively, and has an improved instrument delivery system for faster coronary interventions.
Another new feature in the next-generation PressureWire is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons.
“In the evolution of our PressureWire family, we have long sought to match or exceed the handling performance of conventional workhorse PCI guidewires, a significant challenge owing to the presence of the pressure sensor and signal cables,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “Based on the clinical feedback obtained to date, this eighth generation family of guidewires gives us confidence we have risen to the challenge.”
When integrated into routine lab procedures, measuring FFR, as shown by the FAME (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) study, sponsored by St. Jude Medical, reduces the risk of death or heart attack by 34 percent. PressureWire technology from St. Jude Medical was used exclusively in the FAME and FAME II trials and has been proven in more than 500 additional studies. Using PressureWire Aeris or PressureWire Certus to measure FFR helps ensure access to accurate information in the cath lab, increasing the efficiency and efficacy of coronary revascularization.