Oct 25 2012
Volcano Corporation, a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced the global launch of the PrimeWire Prestige® PLUS pressure guide wire with AcuSense™ technology, which allows for more precise measurements when distal pressure is monitored for longer periods of time.
The new offering is the fourth new pressure guide wire from Volcano in four years and will serve as the platform for Volcano's expanding clinical programs. The PrimeWire Prestige PLUS product will be used in six newly announced Volcano-sponsored clinical studies to explore new indications in stable and unstable CAD, peripheral arterial disease and neurology.
"FAME and now FAME 2 are landmark studies showing how measuring pressure gradients across coronary narrowings can help to improve our treatment strategy for patients," commented Bruce Samuels, M.D., of Cedars-Sinai Hospital in Los Angeles. "We always have been able to see the anatomic outlines of coronary narrowings. However, the ability to now make live pressure measurements enables us to finally understand their functional significance. This technology has galvanized the interventional community and has dramatically improved our ability to provide appropriate care for our patients. It is our role as clinicians to continue to find ways to improve outcomes and make the patient record more complete. Our work with fractional flow reserve (FFR) and other indices will continue to move PCI forward, and help us apply those same principles to similar challenges outside of the heart."
"Our belief is that monitoring distal physiology, such as FFR, throughout a PCI procedure provides more precise information than angiography alone can offer," commented Joe Burnett, executive vice president and general manager of the Functional Management business at Volcano. "Our product focus is on fast, simple and reliable measurements, and the AcuSense technology further simplifies the physician workflow by reducing the need to re-calibrate during those longer procedures. Physicians can now measure distal pressure at baseline, deliver their therapy over the wire, then re-measure at the conclusion to document the impact the therapy had, or the 'functional improvement' in the permanent patient record. There are more than 5 million guide wires used every year alongside angiography, and we are designing our products to be fast and simple enough that they can add a new dimension to x-ray imaging alone, and relay distal physiology data, as well."
"Volcano's pressure sensors with AcuSense technology are proprietary Volcano designs and have been evaluated at every step, from bench-top testing to human evaluation," added Mr. Burnett. "PrimeWire Prestige PLUS pressure guide wires with AcuSense technology are now shipping to customers in the U.S., Europe, Japan and beyond, and will be the catalyst for our global studies showcasing the benefit of distal pressure sensing in numerous coronary and non-coronary applications."
"New technology often leads to unlocking new clinical indications," commented Jasvindar Singh, M.D., of Washington University School of Medicine in St. Louis. "A precision miniature sensor at the end of a frontline guide wire is a tool that has eluded interventionalists historically. Now we can use this tool to learn more about coronary and peripheral artery disease, and the ease of use opens the door for more researchers to participate."
The PrimeWire Prestige PLUS guide wire will be used in six current and up-coming Volcano-sponsored clinical trials including ADVISE II and the DEFINE family of studies (Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect). These studies will further explore clinical and economic outcomes impacted by FFR, coronary flow reserve (CFR), instant wave-free ratio™ (iFR®) and other physiologic indices.