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FDA clears next generation of St. Jude’s fractional flow reserve technology

St. Jude Medical (NYSE:STJ) announced Friday that the  U.S. Food and Drug Administration has cleared the next iteration of its Fractional Flow Reserve technology used to treat clogged arteries. The clearance allows the Minnesota medical device maker to market a new generation of PressureWire Aeris and PressureWire Certus guidewires, which have an “agile tip” whose […]

St. Jude Medical (NYSE:STJ) announced Friday that the  U.S. Food and Drug Administration has cleared the next iteration of its Fractional Flow Reserve technology used to treat clogged arteries.

The clearance allows the Minnesota medical device maker to market a new generation of PressureWire Aeris and PressureWire Certus guidewires, which have an “agile tip” whose performance is similar to the guidewires used in standard percutaneous coronary intervention (PCI).

FFR is a physiological index that can identify which narrowings in coronary arteries are causing the blood flow blockage and can guide an interventional cardiologist to decide which lesions require stents. Currently, physicians use angiography to know which arteries have been narrowed and blood flow obstructed. FFR is meant to be an alternative to such interventions, and St. Jude has proved that the technology is clinically effective.

The new St. Jude Aeris and Certus guidewires are also coated with a proprietary hydrophilic coating that reduces friction, thereby facilitating the placement 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, in a news release. “Based on the clinical feedback obtained to date, this eighth-generation family of guidewires gives us confidence we have risen to the challenge.”

Having proved that FFR works, St. Jude is on a quest to demonstrate that it is more cost effective than standard PCI techniques. In February, the company announced that it has launched a study to enumerate the cost savings from using an FFR-guided approach to PCI, as well as the total savings for the healthcare system annually in Japan, China, India, Korea and Australia.

Not everyone agrees with CEO Daniel Starks that FFR will be an important growth driver for St. Jude. Citigroup analyst Matthew Dodds believes that FFR will be limited because angiography is the accepted standard for PCI. He also believes that overall, PCI procedure volumes are sliding.

Citing the above reasons, Dodds concluded in a research note, “Hence, we just don’t think FFR is meaningful enough to move the needle for St. Jude.”