St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its PressureWire X guidewire fractional flow reserve measurement system and launched the device in the U.S.
The PressureWire guidewire system is designed to measure arterial blood pressure by calculating fractional flow reserve associated with stenosis in patients with coronary artery disease. The next-gen version of the device includes improvements to reduce vessel trauma, the Little Canada, Minn.-based company said.
“St. Jude Medical strives to provide physicians with fractional flow reserve pressure guidewire technology that is backed by ample clinical data and that matches the handling performance of conventional PCI 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. In turn, patients can have peace of mind knowing their physicians have more confidence in their readings,” chief medical officer Dr. Mark Carlson said in a press release.
The company said that along with the commercial release, it also launched the Pressurewire registry trial, which aims to explore outcomes of FFR-guided PCI procedures in patients with acute coronary syndrome.
“For years, clinical research has confirmed that fractional flow reserve is one of the most important tools available when assessing coronary lesions and making informed treatment decisions during percutaneous coronary intervention. The improved design and shape retention of the new PressureWire X Guidewire tip allows us to perform FFR measurements in more tortuous anatomies,” Dr. Annapoorna Kini, of New York’s Mount Sinai Medical Center, said in prepared remarks.
