Direct Flow enrolled its 1st patient in a new U.S. clinical trial for the company’s transcatheter aortic valve implantation system, having earlier this year won FDA approval to launch the study. The study will treat a total of 30 patients from 6 clinical sites in the U.S., the 1st of which was enrolled at the Henry Ford Hospital in Detroit, Mich.
Direct Flow has some serious competition in the TAVI arena and is approaching the market as a relative new-comer, but the company says it can use its greenness to its advantage. Building on experiences with older TAVI systems, Direct Flow designed its device to address complaints surgeons have had with rival device makers’ products.
Direct Flow’s implant features a metal-free frame and a low-profile, flexible delivery system designed to eliminate aortic regurgitation, or valve leakage that has been associated with long-term mortality. The device is also re-positionable and is able to fit in narrower anatomies, potentially opening up new patients as candidates for less-invasive TAVI treatment and giving TAVI procedures the same safety profile as open surgery.
"After surgical aortic valve replacement, aortic regurgitation is rare. We need that same level of assurance after a transcatheter procedure, and we look forward to matching those results in this study of the Direct Flow Medical System," SALUS principal investigator Dr. Patrick McCarthy said in prepared remarks on behalf of the company.
Direct Flow and its TAVI technology will have to face down some of the medical device industry’s largest players, including Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Edwards Lifesciences (NYSE:EW) and St. Jude Medical (NYSE:STJ), in order to gain share in the TAVI arena. But the company sees its predecessors as a boon rather than a burden.
"The beauty of this market is that the giants have done a great job of developing it," Direct Flow CEO Berni Lyons told MassDevice.com in an in-depth interview conducted earlier this year. "In fact, we predicated the company on what we learned from the very early users."
In addition to designing to quell concerns about aortic regurgitation, Direct Flow noted that TAVI technology came with a relatively steep learning curve for physicians just getting the hang of the procedure. Direct Flow’s TAVI device is fully repositionable and retrievable, even after complete deployment, Lyons told us. Physicians can assess the placement of the device and make adjustments as necessary before completing the procedure.
Edwards Lifesciences is the only medical device maker with FDA permission to market a TAVI system in the U.S., having won approval in November 2011, but others are close. Medtronic’s CoreValve was the 1st valve to hit the global market, landing on European shelves in 2007 but the world’s largest medical device company said it doesn’t expect its TAVI device to win FDA approval until 2014. St. Jude Medical expects to begin U.S. IDE trials this year for its Portico entrant.