OptoWire II FFR guidewire receives FDA 510(k) clearance


Opsens has received 510(k) clearance from the FDA for OptoWire II—an optical guidewire developed to measure fractional flow reserve (FFR). The company has already received FDA clearance to sell the OptoWire I, the first generation of its optical guidewire. This latest approval allows Opsens to

According to a press release, Opsens aims to become a key player in the guidewire FFR market with the OptoWire—a nitinol-based optical guidewire. The press release reports that the OptoWire provides intracoronary blood pressure measurements with unique, patented optical pressure guidewire technologies, and states that the wire is immune to adverse effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire that provides optimal performance to navigate coronary arteries and cross blockages with ease and safety. Based on industry sources, the FFR market represented more than US$300 million in sales in 2014 and is expected to reach US$1 billion in the medium-term.

Louis Laflamme, president and chief executive officer of Opsens, says: “Obtaining 510(k) clearance is a significant milestone in our plan to expand the commercialisation of our FFR products. In the past few months, we have taken the necessary steps for a successful launch in the US and in other targeted markets.” He adds: “Also, we are glad to report that we have now successfully completed our move into a new state-of-the-art facility that will allow us to increase production and meet the growing demand for our FFR products.”