ST. PAUL, Minn.–(BUSINESS
WIRE)–St. Jude Medical, Inc., a global medical device company,
today announced it has received U.S. Food and Drug Administration (FDA)
clearance for multiple enhancements to its PressureWire™ Fractional Flow
Reserve (FFR) measurement guidewire. FFR measurement identifies the severity of
narrowings in the coronary arteries and allows for a more effective assessment
of coronary lesions, or blockages, resulting in more accurate diagnosis and
improved appropriate treatment of coronary artery blockages.
The PressureWire with Agile Tip was designed to replicate
the performance of standard percutaneous coronary intervention (PCI) guidewires
and delivers exceptional handling even in the most challenging anatomies.
Available in both of the companys Aeris (wireless) and Certus PressureWire
models, this eighth-generation guidewire also can deliver interventional tools
more easily, for faster and more cost-effective PCI.
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.
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the functional severity
of narrowings in the coronary arteries, and it is measured by PressureWire
Aeris or PressureWire Certus. FFR specifically identifies which coronary
narrowings are responsible for significantly obstructing the flow of blood to a
patients heart muscle (called ischemia), and it is used by the interventional
cardiologist to direct coronary interventions and assess results for improved
treatment outcomes.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting
more control into the hands of those who treat cardiac, neurological and
chronic pain patients worldwide. The company is dedicated to advancing the
practice of medicine by reducing risk wherever possible and contributing to
successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn.
and has four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information, please
visit sjm.com.
