A game-changing therapy for circulatory assistance in heart failure.
CEO: Arnaud Mascarell
Based: Pessac, France
The scoop: Pacemakers and left ventricular assist devices (LVADs) have made a massive difference in the prognoses of people with heart failure, but hundreds of thousands of patients each year can’t benefit from them, especially those whose disease is caused not by electrical disturbances but by weakness in the heart muscle.
FineHeart’s device is a miniaturized, fully implantable pump that is synchronized to the beat of the heart—combining the functions of a pacemaker and an LVAD in a single unit—with the added advantages of being safer and easier to implant.
What makes FineHeart fierce: CEO and co-founder Arnaud Mascarell, a veteran of the medtech industry who spent many years at Medtronic, says that conventional pacemakers still have to rely on a weakened muscle to generate blood flow, which can restrict cardiac output.
With FineHeart’s ICOMS, or Implantable Cardiac Output Management System—first envisaged by the company’s co-founder and chief scientific officer, Stéphane Garrigue—an implanted turbine takes over some of the work of the contracting heart, synchronizing with the heartbeat to propel blood from the left ventricle through the aortic valve and on to the body.
It’s an elegant but challenging concept, and took five years to develop into a viable prototype, mainly due to the challenges of accelerating the flow within the finger-sized device, which incorporates both the inlet and outlet in one unit, and making sure it could be secured within the heart in the precise orientation.
Once that was achieved, FineHeart was able to raise €6.5 million ($7.4 million) in a 2016 series A, and also unlocked additional subsidies and EU grants that swelled its funding to around €11 million. It will need to raise more money to advance the project this year, according to Mascarell.
There are other big advantages compared to current devices. The ICOMS’ battery and connectors are fully implanted along with the pump, so the patient doesn’t have any leads coming out of their body, reducing the risk of infection. Once implanted, the device is controlled and charged via a belt—a bit like a cummerbund worn with a tuxedo—that frees the patient from having to carry around a bulky battery pack. In fact, it’s possible to do away with the external controller entirely for a couple of hours, freeing patients to take a shower or carry out other daily activities. FineHeart is aiming for a life span for the device of at least two years.
The surgical procedure for implantation is also much simpler, using a well-established technique called a minithoracotomy, with no need for extracorporeal circulation, or the bypass that is required with a traditional LVAD implantation. That means patient recovery time is much quicker, and the risk of complications should be lower. Animal tests suggest it could take as little as one hour to implant the ICOMS, which is at least three to four times quicker than for an LVAD.
Mascarell thinks ICOMS’ value could go even further, however. Hypothetically, it could be implanted earlier in the course heart failure rather than waiting until the critical end stage when LVADs are typically used as a bridge to transplantation. And if the patient were to recover thanks to that early intervention and heart support, FineHeart’s device can also be removed easily.
All that is a long way off of course, and there is still a lot more work to be done before the device can even advance into human trials. Mascarell estimates that could be finished around the end of 2021, and once human studies start, another couple of years at least will be required before it will be in a position to file for approval—hopefully around the end of 2023.