Aum Cardiovascular today released preliminary results from the pivotal clinical trial of its Cadence heart disease diagnostics device, touting the device’s efficacy at detecting significant obstructive coronary artery disease.
Aum’s Cadence is designed to identify obstructions in the coronary arteries by detecting acoustic signals generated by the turbulence created as blood flows past the obstruction, according to the company.
A total of 1,014 patients are enrolled in the Turbulence trial, which looks to examine the use of the device to detect clinically significant CAD, the Northfield, Minn.-based company said.
While Aum Cardiovascular did not release preliminary data, it touted that a preliminary analysis of data from the trial indicated the device “is effective at ruling out significant obstructive cornary artery disease.” No adverse events related to the device were reported.
“We are pleased to be able to provide these preliminary results. The data analysis to date indicates that if a patient does not have significant obstructive coronary artery disease, the CADence System will be able to confirm this approximately 9 out of 10 times. This efficient, noninvasive and reusable device has a lower safety risk profile than other diagnostic screening tests such as such as nuclear stress testing, computed tomography and angiography. We look forward to launching this technology in Europe early next year, and plan to follow with a US launch later next year,” CEO Marie Johnson said in a prepared statement.
Last November, AUM Cardiovascular said it completed enrollment for the pivotal Turbulence study of its CADence device. The company said it’s taken 3 years to recruit the over 1,000 patients for the trial.
Aum Cardiovascular was founded by CEO Marie Johnson after the unexpected death of her husband from a heart attack at age 41.
MassDevice.com spoke to Johnson at the DeviceTalks: Minnesota event last September about her experience creating and guiding the med-tech startup, which has now transitioned into clinical trials.