FDA approves St. Jude Medical's enhanced PressureWire for FFR measurement
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By: Katie Bell
Ref: St. Jude Medical, StreetInsider, NASDAQ
Published: 03/23/2012
St. Jude Medical on Friday announced that it received FDA clearance for multiple enhancements to its PressureWire Fractional Flow Reserve (FFR) measurement guidewire.
The PressureWire with Agile Tip was designed to replicate the performance of standard percutaneous coronary intervention guidewires and is available in the wireless Aeris and Certus PressureWire models. Another new feature is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons, the company noted.
"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 company's 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," he added.
The PressureWire with Agile Tip was designed to replicate the performance of standard percutaneous coronary intervention guidewires and is available in the wireless Aeris and Certus PressureWire models. Another new feature is a proprietary hydrophilic coating that reduces friction within guide catheters and stent delivery catheters, allowing for easier deployment of stents and coronary balloons, the company noted.
"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 company's 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," he added.