Opsens Receives FDA Approval of OptoWire III
January 13, 2020—Opsens Inc. announced 510(k) clearance from the FDA to market its OptoWire III coronary pressure guidewire for physiological measurements such as fractional flow reserve (FFR) and diastolic pressure ratio (dPR).
According to the company, the OptoWire family of products is used to diagnose and guide the treatment of patients with coronary heart disease. In addition to the United States and Canada, Opsens has also filed applications for approval in Japan and Europe.
The design of the next-generation OptoWire III device provides increased maneuverability, strength, and a shorter flexible tip, particularly for use in challenging and complex cases. Opsens has also improved the efficiency of the manufacturing process of its flagship product.
Morton Kern, MD, has extensive experience with the OptoWire II device and was the first interventional cardiologist to use OptoWire III in the United States. Dr. Kern is Chief of Medicine at Long Beach VA Medical Center in Long Beach, California.
In Opsens’ announcement, Dr. Kern commented, “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.”
Dr. Kern continued, “I also appreciate the ability to measure a variety of indices from FFR to non-hyperemic 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.”