Direct Flow's next-gen inflatable TAVI looks good at 30 days
Medical device company Direct Flow Medical's transcatheter aortic valve implantation system reduces valve leakage in 30-day clinical trial results.
Medical device maker Direct Flow Medical unveiled 30-day results for its namesake transcatheter aortic valve implantation system, touting reduced valve leakage and procedure-related complications for the inflatable device.
In the study, which will enroll up to 100 patients, Direct Flow's TAVI met primary mortality endpoints with zero incidents of major vascular complications and with 95% of patients experiencing mild or less paravalvular regurgitation.
Valve leakage, which can lead to aortic regurgitation, is one of the chief challenges with 1st-generation TAVI systems and one that many next-generation devices are looking to address.