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Opsens Inc. Announces 510(k) Clearance from the FDA to Market its Diastolic Pressure Algorithm

December 23, 2019

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Opsens Inc. announces 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its diastolic pressure algorithm (“dPR”).

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Coronary physiology has been in constant evolution with the expanded use of Fractional Flow Reserve (“FFR”) and the support of strong clinical data and cardiology societies recommendations. More recently, the option for coronary physiology without hyperemia induced by the injection of heart stimulating drugs has emerged. Opsens has developed its proprietary diastolic pressure ratio (dPR) to meet this need. Non-Hyperemic Pressure Resting indices (“NHPR”), such as Opsens’ dPR, are beneficial for some patients as they reduce procedure time, costs and discomfort.

Opsens is excited to offer its drug-free solution to the U.S. market. “This new feature is an important part of our U.S. market penetration plan. dPR has been a major factor in the significant growth of our revenues in other regions, where it is already approved. Opsens has experienced solid growth in the U.S. in recent quarters and this new dichotomic single cut off algorithm approval will further support our growth plans.” said Louis Laflamme, Opsens’ President and CEO.

Dr Ziad Ali, MD DPhil, Columbia University Medical Center/New York-Presbyterian Hospital, is the first dPR user in the U.S. “Opsens’ OptoWire is a pressure guidewire that differentiates itself by its superior steerability and accuracy. So far, the usage of the OptoWire has been limited to FFR measurements. We are glad to see the availability of a resting index on Opsens technology.” said Dr Ali. “The team appreciated the speed and ease of use of a physiological assessment without the use of adenosine and the OptoMonitor display that was clear and easy to use. Opsens’ dPR resting index and dPR pullback are major additions to the Opsens’ portfolio,” concluded Dr Ali.

“Literature has shown that accuracy of pressure measurement is even more crucial for non-hyperemic indices. 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 2nd generation pressure sensor. We are excited to bring our solution to the U.S. market where we expect even higher growth,” concluded Mr. Laflamme.

See Full Press Release: Opsens Receives dPR Clearance from the FDA

Written by: Opsens

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