St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe.
The company announced the launch and clearance at the EuroPCR meeting in Paris this week.
“Fractional flow reserve has become an indispensable tool for assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention. The improved design of the new PressureWire X guidewire tip will simplify the fractional flow reserve procedure by enabling access to lesions in patients with tortuous, complex anatomy,” Dr. Bernard De Bruyne of Belgium’s CVC Aalst said in a press release.
The PressureWire FFR guidewire measurement system is designed to support lesion assessments during percutaneous coronary interventions to aid physicians in making decisions for treatment, the St. Paul, Minn.-based company said.
Data from the Fame trial of the PressureWire FFR system indicated that the device improved patient outcomes over angiography alone in patients with coronary artery disease.
Results from the trial also indicated a reduction in the risk of death or heart attack in patients undergoing PCI and reduced health care costs for FFR-guided treatment.
“St. Jude Medical strives to provide physicians with fractional flow reserve pressure guidewire options that are backed by clinical data and match the handling performance of conventional workhorse PCI guidewires, which is a combination that we have always prioritized in designing and developing the PressureWire series of FFR guidewires. The new PressureWire X guidewire shows our dedication to providing physicians with cost-effective, easy-to-use technologies that aid them in making the best treatment decisions for their patients,” chief medical officer Dr. Mark Carlson said in a prepared statement.
St. Jude said that with the launch, it initiated the PressureWire Registry multicenter clinical trail to evaluate the use of FFR measurement and clinical outcomes of FFR-guided PCI in patients with acute coronary syndrome.
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