Merit Medical has announced receiving notification of substantial equivalence from the US FDA for the Corvocet Biopsy System, which is intended for use in obtaining core biopsy samples from the liver, kidney, prostate, breast, lung and various other soft tissue tumours.
The proprietary device comes in standalone packaging and also as a component in certain kits to provide convenience for hospitals and physicians. It offers features and performance characteristics that were designed from clinician input to reduce sound levels and provide one-handed use, a press release from Merit says.
Corvocet is scheduled to be introduced in the USA over the next thirty days, with European release following receipt of the CE mark. Merit will highlight the new biopsy system at the the Society of Interventional Radiology’s (SIR’s) annual meeting to be held 2–7 April in Vancouver, Canada.
“The Corvocet Biopsy System is Merit’s first entry into the biopsy market and is the first of several biopsy devices we expect to introduce in the future,” said Fred P Lampropoulos, chairman and CEO of Merit. “We believe the introduction of the Corvocet, a new line of One-Step Centesis Catheters, the SwiftNinja Steerable Microcatheter, the Elation Balloon Dilator, and several other products slated for release will provide support for our projected growth and profit expectations for 2016 and beyond.”