Opsens (TSX:OPS; OTCQX:OPSSF) received 510(k) clearance from the FDA to market its diastolic pressure ratio (dPR) algorithm.
The algorithm is designed to be used with Opsens’ OptoWire, a coronary guide wire used for vascular physiological measurement, particularly fractional flow reserve (FFR).
Opsens’ dPR algorithm is a non-hyperemic pressure resting index designed to accurately measure arterial pressure in the absence of heart-stimulating drugs, which has become a new option for patients undergoing FFR procedures.
“Literature has shown that accuracy of pressure measurement is even more crucial for non-hyperemic indices,” Opsens president and CEO, Louis Laflamme, said in a statement.
“International cardiologists greatly appreciate the opportunity to combine our dPR with the OptoWire, which is known for its steerability and certainly for the unsurpassed accuracy of its second-generation pressure sensor,” he added.
In addition to the U.S., Opsens’ dPR is approved in Japan, Canada and Europe.
