Direct Flow Medical and CEO Bernie Lyons are betting that its heart valve technology can use the decade's worth of experience of the medical device industry's transcatheter aortic valve implant pioneers to leapfrog the competition.
Being one of the smallest players on the field means you've got to differentiate yourself to stand out against the titans of the game, and that's what Direct Flow Medical CEO Bernie Lyons aims to do.
Direct Flow and its transcatheter aortic valve implantation technology must 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. Lyons told MassDevice.com that he has simple plan – he's gaining from others' experiences.
"The beauty of this market is that the giants have done a great job of developing it," Lyons told us. "In fact, we predicated the company on what we learned from the very early users."
Direct Flow was started in 2004 with the intention of responding to a growing concern among physicians using TAVI technology. Early generations of the heart valves, although effective and comparable to surgical valve replacement, were more prone to a type of valve leakage that could cause death, according to some studies. The devices also came with a steep learning curve for physicians, who usually have only 1 chance at implanting the devices.
Direct Flow developed its bovine tissue valve with an inflatable, flexible cuff to address concerns about leakage, or valve regurgitation, as well as to simplify the implantation process. That design helps the device fit different aortic valve anatomies, Lyons said
"We use a metal-free frame for our valve, which, unlike others, allows us to address some of the key clinical issues in the marketplace," he explained. "Because we have the metal-free structure, it will conform to any annulus in terms of its placement, thereby virtually eliminating aortic regurgitation."
"The beauty of this market is that the giants have done a great job of developing it."
Other TAVI players have also taken steps to reduce the incidence of regurgitation in their devices. Medtech giant Medtronic in October 2012 reported early results from a pivotal CE Mark trial of its Engager TAVI system, touting reduced valve leakage and easier device deployment. Similar reports came from an early feasibility study of Boston Scientific's Lotus device, with investigators saying it all but eliminated aortic regurgitation and allowed precise positioning on the 1st attempt.
Direct Flow's TAVI device is also fully repositionable and retrievable, even after full deployment, Lyons said. Physicians can assess the placement of the device and make adjustments as necessary before completing the procedure.
"The most important thing that the 1st physicians that used the early technology told us was that they wanted something repositionable, so that you could optimize its placement," Lyons said. "You don't want to treat these patients with aortic stenosis and leave them compromised with another disease of aortic regurgitation."
The flexibility of the metal-free structure also allows the valve to come with the lowest-profile, most flexible delivery system, which further eases the process of threading the device through the body and into the heart, he added.
"This technology really does offer something unique to the marketplace. Because of that ability to optimize and assess the outcome before deploying it's what we consider a true 2nd-generation device," Lyons told us.
Many elements of Direct Flow's engineering and market strategy came from watching its predecessors, capitalizing where possible on more than 10 years of TAVI experience. Choosing to avoid a metal structure was 1 of the key factors in differentiating its TAVI system from others, but Direct Flow also took cues from their regulatory bids and clinical programs as well.
"Being in this industry for over 25 years, clinical data is the most important thing to the marketplace."
"We watched them in all their approaches, and certainly working through the regulatory and clinical process has been very helpful to us, by seeing how they've done it," Lyons said. "In our Discover trial, which is a CE Mark trial, we used a core lab, just like the FDA requires and has been done in the U.S. for [Edwards Lifesciences'] Partner I and Partner II trials."
Direct Flow used the Discover trial results to help land a recent CE Mark approval for the European market. The company said it plans to use the data for its FDA application as well. Using an independent core lab to assess all the hemodynamic outcomes for its subjects means the study "is to the standards of the U.S. FDA," Lyons said, adding that Direct Flow was the 1st to publish TAVI study data in that manner.
"Being in this industry for over 25 years, clinical data is the most important thing to the marketplace," he said.
The Discover study demonstrated of Direct Flow's TAVI system met primary its mortality endpoints, with no incidents of major vascular complications and with 95% of patients experiencing mild or less paravalvular regurgitation at 30 days. The company has begun the FDA submission process, is in "constant discussions" with health regulators and hopes to begin an investigational device exemption study in the 2nd half of this year, Lyons told us.
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 yea for its Portico entrant.
For its part, Direct Flow hopes to leverage strong clinical results to draw market share away from well-established industry players.
"Aortic regurgitation is the number 1 clinical issue that our physicians are dealing with for these patients," Lyons said. "Because of our unique design and ability to eliminate that problem, we think that clinicians will accept this technology – despite us being a small, privately held company."