Opsens has received 510(k) clearance from the FDA to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as fractional flow reserve and diastolic pressure ratio (dPR). According to a press release, the OptoWire III is the latest version of OptoWire and the OptoWire family of products are used to diagnose and guide the treatment of patients with coronary heart disease.
Securing 510(k) is an important step, the press release states, in Opsens’ plan to grow revenues in the USA as the Company is constantly improving its products to increase penetration in the country and other targeted markets. In addition to the USA and Canada, Opsens has also filed applications for approval in Japan, and Europe.
Morton Kern (Long Beach VA Medical Center, USA), who has extensive experience with the OptoWire II, comments: “I have been using the OptoWire for many years and consider it to be the best pressure guidewire on the market to access, measure, treat and confirm percutaneous coronary interventions (“PCI”) in patients with coronary disease. The OptoWire III provides unexpected improvements over the OptoWire II—steerability is on par with workhorse guidewires while providing even more accurate and sustainable measurements. I also appreciate the ability to measure a variety of indices from FFR to non-hyperaemic Pressure Ratios such as Opsens dPR. I am a firm believer in coronary physiology pre- and post-PCI, and although usage has remained limited mostly due to device limitations. This product is unique and further supports what the clinical studies and medical societies recommend.”
Louis Laflamme, president and CEO of the company, reports: “Opsens is pleased to receive this important regulatory approval as we continue to optimise both the performance and production of our flagship product family. Physicians will appreciate a design with increased manoeuvrability, strength and a shorter flexible tip, particularly in challenging and complex cases. In addition to design and mechanical improvements, Opsens has also improved the efficiency of the manufacturing process of its flagship product, which will result in improved gross profit margins going forward.”