It's been almost a year since St. Jude Medical announced its acquisition of left ventricular assist device (LVAD) maker Thoratec, and the past 12 months have shaken up the LVAD market. Since then, St. Jude Medical (STJ) itself has been purchased by Abbott (ABT) while HeartWare (HTWR), the other major seller of LVADs in the United States, was last month picked up by cardio powerhouse Medtronic (MDT).
But wait. More change may be coming to the LVAD industry. That's because Houston, TX-based ReliantHeart is unveiling a number of new technologies that could help improve care for patients with severe heart failure.
Rodger Ford, ReliantHeart's candid CEO, spoke with MD+DI recently about the company's forthcoming aVAD intraventricular heart pump and several other novel features that he said make ReliantHeart special.
"Here are the value generators for this pump [aVAD]. It's really small. It plugs right into the ventricle. It has 24/7 remote monitoring. It doesn't create hemolysis; therefore, no thrombus. It has pulsatility that passes the pulse of the ventricle right through the pump--remote monitoring shows it," Ford said.
This isn't a far off, pie-in-the-sky invention either. The aVAD is anticipated to enter Europe in mid-summer 2016, according to information on the company's website. It is also expected to enter an FDA IDE trial in late 2016 or early 2017 with a short-long trial design. Ford explained that the aVAD is being studied in animal implants in the United States now.
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If all that is coming sooner than you expected, wait--there's more. Ford discussed "Liberty," a fully implantable LVAD system that is being developed and could be seen in late 2017 or 2018. A wirelessly-powered, fully implantable device that would allow LVAD patients the freedom to go about their daily lives without a cable coming out of their body or a heavy battery pack has been a dream of the industry for years, but the technical challenges and regulatory hurdles have made many onlookers skeptical.
Well-known clinicians in the LVAD field sit on ReliantHeart's Scientific Advisory Board, including Dr. Valluvan Jeevanandam, chief of cardiac and thoracic surgery at University of Chicago Medicine, Dr. William Cohn of the Texas Heart Institute, and Dr. Jan Schmitto, director of the mechanical circulatory support and cardiac transplantation program at major VAD center Hannover Medical Center in Germany. Sailesh Saxena, chief financial officer of the company, told MD+DI that these advisors will "weigh in with their experience with our device, and that's going to help us propel forward in a big way."
What to Know About the aVAD
An image of ReliantHeart's new LVAD, the aVAD, is displayed prominently on the front page of the company's website. According to its description there, is it a 2.48-cm diameter intraventricular heart pump that has a 1.2-cm diameter flow tube inside. Its blood path--how the blood travels inside the pump--is the same as ReliantHeart's CE-Marked HeartAssist5 LVAD, Ford explained.
The aVAD and HeartAssist5 are both axial flow LVADs. The aVAD has the added feature of active magnetic stabilization and directional retention. Ford explained that the magnetic stabilization pulls the pump's impeller precisely between the front and rear retention cups. Within the aVAD's impeller, all eight magnets now communicate with each other--Ford noted that the HeartAssist5's design "only capture five out of the eight magnets." Still, he emphasized, the aVAD has the same blood path as the HeartAssist5. "We've made this really powerful new pump but the blood path is exactly the same. It only changes things inside the impeller, not outside the impeller," he said.
Referencing an LVAD Comparison Chart, Ford pointed out that the aVAD is significantly lighter in weight than the Thoratec and HeartWare pumps and slightly lighter than the HeartAssist5. The ReliantHeart devices have natural measurable pulsatility and Ford said that both the aVAD and HeartAssist5 have low hemolysis and do not show any patterns of pump-created thrombus. He added that no ischemic stroke cases have been seen in about 90 HeartAssist 5 patients. This is significant, since stroke is one of the most concerning adverse events related to LVAD therapy.
Another frequent adverse event associated with LVADs is driveline infection. This is often seen at the site where the system's driveline exits the patient's body. LVAD pumps are sometimes replaced as a result of the infections. The aVAD, Ford said, will have a cable that can be disconnected below the patient's diaphragm. "Why replace the pump? Why not replace the cable just below the diaphragm?" he explained.
|This image emphasizes aVAD's small size.|
ReliantHeart has flow measurement through a sensor supplied by Transonic that is designed to accurately measure flow at the outbound end of the heart pump. According to Ford and information on ReliantHeart's website, the company's LVADs are the only ones to offer direct flow measurement, as opposed to an estimate or calculation based on speed and power. Having this flow measurement may give clinicians and surgeons the ability to detect problems earlier.
Remote monitoring is yet another novel feature for ReliantHeart. Patient data is sent to clinicians using a cellular communication network the company has been developing, which Ford said consists of hundreds of carriers worldwide. "Our controller . . . works all over the world," Ford said. "Works in Baghdad, imagine that."
Ford said he believes the LVAD community will begin to see remote monitoring as a must-have to alert clinicians to potential problems like dehydration or atrial fibrillation. "This stuff doesn't come quickly. It's a whole change in the way clinicians will behave. Eventually, it's going to take over the space."
More on Liberty
Much has been made of the potential for a fully implantable LVAD, but wireless power transfer is a high hurdle. Thoratec announced back in 2011 that it had been working for months with WiTricity Corporation on wireless resonant energy transfer technology. HeartWare also began working with Dualis MedTech GmbH that year on transcutaneous energy transfer.
ReliantHeart is collaborating with Dualis MedTech on Liberty. Ford explained that the fully implantable system is being developed step by step. The development calls for aVAD to be upgradeable to Liberty, meaning that Liberty will consist of the aVAD pump with an internal batter and energy transfer system all inside the body.
The aVAD's low power draw of just 3.5 watts is what is expected to enable Liberty. Ford said he anticipates a patient with Liberty would be able to live their life "untethered" for approximately 5-8 hours.
Ford noted that he's heard plenty of skepticism about Liberty. Still, he said ReliantHeart is well-positioned to be first to a fully implantable LVAD system because of the company's small, nimble size. "There's a lot of magic here . . . we've got a lot of doers," he said.
FDA Trial Plans
In the United States, the aVAD is expected to be part of a short-long FDA IDE trial with a six-month endpoint for "short" and a 24-month endpoint for "long," Ford said.
Ford said he believes ReliantHeart's technology should make Medtronic and Abbott sit up and pay attention. Though he acknowledged that the massive medtech players have the infrastructure and relationships that are valuable for selling LVADs, he also isn't worried about having enough centers and surgeons interested in the FDA trial. He pointed out that surgeons have been looking forward to a small, intraventricular LVAD. "We won't give [surgeons] just one thing to publish, we [will] give them a whole matrix of things to publish about," he said.
Whatever happens next, one thing's for sure: ReliantHeart is worth watching.
[Images courtesy of ReliantHeart.com]
Correction: An earlier version of this article incorrectly described the remote monitoring feature as requiring an interrogating device to be placed near the patient's chest. An interrogating device is not needed and data is sent continuously.