WallabyPhenox turns to Oracle Clinical One to support successful device trials
The medical technologies company uses Oracle Life Sciences Clinical One RTSM to help secure FDA clearance on its thrombectomy device.
“The pRESET Thrombectomy Device has been available in Europe for more than a decade. Using Oracle Clinical One RTSM, our recent US clinical trial went smoothly, and we now have FDA clearance for the US market. The Oracle team was able to configure RTSM to handle our uniquely complex randomization and stratification requirements. We’re delighted and would like to thank the Oracle team for their part in helping us bring this device to market.”
WallabyPhenox provides technologies and solutions for the treatment of neurovascular diseases. The organization’s pRESET Thrombectomy Device for the treatment of acute ischemic stroke had been readily available in Europe for more than 10 years, but the device did not have clearance from the U.S. Food and Drug Administration (FDA) for sales in the United States. As part of its efforts to achieve FDA clearance, WallabyPhenox chose Oracle Clinical One Randomization and Supplies Management to support the government’s requirements without the need for programming or coding, which streamlined the clinical trial workflow. The trial was a success, and WallabyPhenox quickly secured FDA clearance.