Six-month results confirm no aortic regurgitation with Direct Flow Medical’s TAVI device

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Results from the DISCOVER trial, which were presented at the TCT conference, show that no patients who received the Direct Flow Medical’s transcatheter aortic valve implantation (TAVI) system had moderate or severe post-procedural aortic regurgitation at the six-month point. They also showed that the rate of freedom from all-cause mortality was 96% at six months.

According to a press release, the Direct Flow Medical TAVI device is designed to minimise the risk of aortic regurgitation by enabling in-situ haemodynamic assessment during the procedure, as well as unlimited repositioning until optimal valve placement is achieved. The press release reports that the results from the DISCOVER trial confirm the system’s ability to virtually eliminate aortic regurgitation, with no patient experiencing moderate or severe aortic regurgitation at six months. Additionally, the mean gradient of 13.0mmHg demonstrated that the Direct Flow Medical valve can significantly reduce, and maintain, low transvalvular gradients over time.


The safety profile of the Direct Flow Medical system was confirmed with a 97% VARC defined combined safety rate at six months with no additional strokes (major or minor) and no patient experiencing a myocardial infarction in the evaluable cohort. The system avoids rapid pacing of the heart during deployment and does not require post-dilatation following placement, minimising the risk of haemodynamic instability for patients.


Principal investigator Joachim Schofer, from the Medical Care Center, Hamburg, Germany, presented the results at TCT and says: “These data show that the excellent results obtained with the Direct Flow Medical system are sustainable over time. The Direct Flow Medical system is able to virtually eliminate aortic regurgitation with outstanding patient safety. These results continue to be unprecedented for a TAVI device.”


The DISCOVER Trial is a prospective, multicentre study conducted at nine European sites in 100 patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair.

 

 

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