Direct Flow Medical said last week that 1-year data from a post-market study of its transcatheter aortic valve implantation system showed a 95% rate of mild or no paravalvular regurgitation.
The low rate of paravalvular leaks is of primary importance to the TAVI market, Direct Flow CEO Dan LeMaitre told MassDevice.com last week, as the procedures become more common and the technology moves from only extreme risk patients to those with surgical options.
“As we start to see this therapy adopted in broader portions of the population, we’re going to have to be less cavalier about paravalvular leaks because you can stress a heart for a long time with residual regurgitation,” LeMaitre said. “As you know, patients always want less invasive options. When you can marry a less invasive procedure with outcomes that are either on par, and some of the survivor data would suggest better than surgery, its pretty telling value proposition. So the fact that at 1 year we had 95% of our patients that had PVL of mild or less, thats a significant finding.”
LeMaitre joined Direct Flow last May from Medtronic (NYSE:MDT), where he landed after leading CoreValve to an $800 million acquisition by the medical giant.
The registry data, from a study of 200 patients treated with Direct Flow device, showed an 82% rate of freedom from all-cause mortality and a 90% freedom from cardiovascular mortality at 1 year. The numbers line up with those demonstrated during the company’s pivotal trial of the device, LeMaitre told us.
“When you do look at our rates of PVL, it is certainly some of the lowest rates of PVL in TAVI devices. We also had a freedom from all-cause mortality, or survival rate, of 82% at 1 year, which again is some of the best data out there in terms of extreme-risk patients,” he said. “And again, by definition, extreme-risk patients are deemed not candidates for surgery. So that’s the most exciting message. We’ve been able to show, in a real-world setting, in a post-market registry, that the results we had in our original pivotal study are confirmed with this 1 year data.”
LeMaitre said that the rate of new bradycardia pacemaker dependence also made Direct Flow’s device stand out from the crowd, reporting a 12% rate of dependance on newly placed brady pacers in patients treated with the device.
“Our rate of pacing in this study, new Brady pacemaker dependency, is 12%, which again is some of the lowest new patient pacing numbers that have been demonstrated. And we think our numbers are headed lower,” he said. “Some of the competitive devices we’re facing in the market have rates of 15% to 20%, and 1 of them is actually over 30%. So it’s a significant benefit because you simply don’t want to have patients become Brady pacemaker-dependent. There’s also obviously cost of having to put Brady pacemakers in patients.”
Lemaitre, at 1 time a healthcare analyst for Merrill Lynch and Cowen & Co., worked as Medtronic’s senior vice president for strategic planning & business development before moving to the CEO spot at CoreValve in 2008. Medtronic acquired CoreValve the next year. He is also chairman at Bioventus, a Smith & Nephew (FTSE:SN, NYSE:SNN) spinout, lead director at Endologix (NSDQ:ELGX) and a director at Globus Medical (NYSE:GMED).
Having spent more than 7 years in the TAVI market, LeMaitre said it’s satisfying to see how the industry is changing and the effects the transcatheter technology was making on the market.
“I think its incredibly gratifying as this market now comes on its 8th year, that there are now probably close to 80,000 patients or so patients that will receive a TAVI device this year. The market is somewhere between $1.5 billion to $2 billion. It’s a huge referendum on the utility of the tech,” LeMaitre said. “At the end of the day, it appears most clinicians who are treating patients will tell you that this will eventually be used not only in extreme-risk, but high- and intermediate-risk, and even talk about going into low-risk patients. So it’s gratifying to watch this technology change lives, save lives. I think it’s something that when you step back and look at seminal events in the medical device industry, there’s very few times when you can just look at a paradigm change and recognize that amazing things are being done for patients.”
Direct Flow’s system received CE Mark in January 2013. The company is enrolling subjects in a planned, 1,000-patient pivotal study of the device in the U.S., LeMaitre told us.