Transcatheter heart valve innovator Direct Flow Medical®, Inc., has received CE Mark for the first fully repositionable 29mm transcatheter aortic heart valve, delivered through its flexible, 18 French transfemoral delivery system. This news comes in the same week that the company has announced completion of enrollment in its US feasibility trial, so-called SALUS, which will assess the safety of the Direct Flow Medical system to treat patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR).
We’ve covered the Direct Flow valve extensively on our pages and on our sister site, whatistavi.com. The device’s unique, double-ring design provides a degree of conformability to the anatomy that looks unlikely to be matched by the array of competitive scaffold-based systems. By creating a tight and durable seal around the annulus the Direct Flow valve is designed to virtually eliminate aortic regurgitation in all sizes of annulus by allowing complete assessment of hemodynamic performance and unlimited repositioning of the valve after full deployment.
The Direct Flow Medical Transcatheter Aortic Valve System is indicated for the treatment of patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR). The portfolio now includes 25mm, 27mm and 29mm transcatheter aortic valves, all delivered through its flexible, 18 French delivery system, which have received the CE Mark and are currently commercially available in Europe. The new approval expands the population of patients who can be treated using the Direct Flow Medical valve to patients with annulus sizes ranging from 21mm to 28mm.
“As with the smaller sizes of the Direct Flow Medical valve, the implantation of the 29mm valve is precise and fully controllable,” said Christoph Naber, M.D., from the Contilia Heart and Vascular Center, Essen, Germany. “With this new valve size, a broader patient population will be able to benefit from the unique advantages of the Direct Flow Medical system.”
“Until now, patients with large annulus sizes who could not undergo surgical valve replacement had limited options, as other commercially available valves often leave significant aortic regurgitation at larger sizes and are not repositionable or retrievable,” said Bernard Lyons, President and CEO of Direct Flow Medical. “With the addition of the 29mm valve to our portfolio, we can now greatly improve outcomes for this group of patients, as well.”
Meanwhile, in the US, the news that the SALUS trial has completed enrollment means the Direct Flow Medical valve becomes the first transcatheter aortic valve designed to meaningfully improve aortic regurgitation outcomes that has been studied in a U.S. clinical trial. What happens next is that the company will also hope to get its pivotal US trial underway this year.
That will no doubt depend on outcomes from the SALUS Trial, which is a non-randomized, multi-center, core lab-adjudicated, IDE trial. If it can replicate the impressive outcomes and reduction in regurgitation seen in the company’s EU DISCOVER CE Mark trial, that should provide evidence enough to proceed.
Source: Direct Flow Medical, Inc.