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Fractional Flow Reserve Measurement System Cleared by FDA
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St. Jude Medical announced the FDA cleared for marketing a fractional flow reserve measurement system designed to identify CAD severity in patients undergoing PCI.
The system (PressureWire X Guidewire), which offers improved shapeability and shape retention in an effort to reduce vessel trauma, has now been launched in the United States, the company said in a press release.
“For years, clinical research has confirmed that [FFR] is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during [PCI],” said Annapoorna S. Kini, MD, director of the cardiac cath lab and the interventional fellowship program at Mount Sinai Medical Center. “The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies.”
St. Jude Medical also announced the launch of the PRESSUREwire REGISTRY, a multicenter clinical trial to determine the routine use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with ACS.
Disclosure: Kini reports no relevant financial disclosures.