Out of San Diego, CA, Volcano Corporation has announces 510(k) clearance, CE Mark approval, and first clinical use for the PrimeWire PRESTIGE Pressure Guide Wire for use in patients who have both single-vessel and multi-vessel coronary artery disease. The next-generation guidewire provides functional measurements of blood pressure and flow parameters from inside the vessel to aid physicians in multi-vessel disease decision-making.
From the press release:
The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory. PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.
"The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "One key hurdle that physicians continuously battle with is the accurate and efficient diagnosis of lesion significance at the time of the procedure. Any improvement to the performance of today’s FFR wires that make assessment of multi-vessel disease lesions easier and faster is a welcome change to physicians."