Opsens receives 510(k) clearance for the OptoMonitor II providing extended indication



Opsens has announced 510(k) clearance from the US Food and Drug Administration (FDA) for the OptoMonitor II, a new multimodality monitor designed to combine the ability to measure fractional flow reserve along with measuring intravascular and intracatheter pressure.

In the USA, Opsens already sells its products to measure fractional flow reserve for diagnostic and treatment guidance in patients with coronary heart disease. The OptoMonitor II is now indicated to be used with FDA-cleared Occlusion Perfusion Catheter from Advanced Catheter Therapies and its partner Toray Industries. The Occlusion Perfusion Catheter is indicated for localised infusion or irrigation diagnostic and therapeutic agent to the peripheral vasculature.

“We are pleased to provide our products and technologies to partners like Advanced Catheter Therapies and Toray for opportunities with strong potential such as Occlusion Perfusion Catheter,” says Louis Laflamme, president and chief executive officer of Opsens. “This product is designed for the infusion of therapeutic agents in the peripheral vasculature.”

Opsens aims to become a key player in the guidewire fractional flow reserve market with the OptoWire, a nitinol-based optical guidewire, according to a press release. The OptoWire is designed to provide intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable fractional flow reserve measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire that is intended to provide optimal performance to navigate coronary arteries and cross blockages with ease and safety.