Cardiovascular Systems Inc. said the U.S. Food and Drug Administration approved the pre-market application of its medical component ViperWire.
Pre-market applications, or PMAs, are submitted by manufacturers if a device or medical component is considered high risk and completely new to the market. PMAs take a longer time, cost more money in user fees and have stricter review procedures, usually requiring clinical data that are only required in some 510(k) reviews.
Cardiovascular Systems' ViperWire advance with flex tip is meant to provide superelasticity and flexibility to physicians treating counter coronary artery calcification with the company's Diamondback 360 system. It is the first FDA-approved nitinol guidewire device in America, the St. Paul, Minn.-based company said in a Sept. 24 press release.
