CorWave, a startup focused on the development of innovative blood pumps based on wave membrane technology, announced the promising early results for its left ventricle assist device (LVAD). The results were presented at the 10th European Mechanical Circulatory Support (EUMS) Summit in Paris. The CorWave pump’s distinctive features include pulsatility and a blood speed close to the physiological pace, while requiring low-invasive surgery. These benefits should reduce adverse effects, allowing for the treatment of more patients.
The results were presented in a poster session at EUMS, held from December 2-5, 2015 and during a session dedicated to innovative technologies, held on December 4. The data presented showed that the pump will be able to fully support a patient in pulsatile mode based on the high hydraulic power generated by the pump and its ability to instantly change flow rate. The CorWave physiologic pulsatile function has been proven to be successful in in vitro and in vivo environments.
Mechanical pumps can significantly extend the life of late-stage heart failure patients. However, patients implanted with current devices experience significant adverse effects such as strokes, hemorrhages, clots or gastrointestinal bleeding, resulting in re-admission to hospital and reduced quality of life. The CorWave technology aims to reduce these adverse events, significantly improving the patient’s quality of life and cutting the overall cost of treatment.
CorWave is the only company working on an alternative LVAD to rotary pumps, whether marketed or in development. Using a completely novel approach, it has developed a system based on a wave membrane. The undulating polymer membrane gently pushes the blood on both sides of a membrane, from the outer edge to the inner orifice, where it exits the pump. The instantaneous change in output of the CorWave pump produces a pulsatile flow that mimics the action of the heart. Despite its small size, the CorWave device can pump 4 to 10L/min and therefore totally replace heart function. The blood velocity induced by the pump (1.5m/sec) is similar to the blood velocity of a healthy heart and much lower than the ones observed in rotary pumps (4-10 m/sec).
“We believe the gentle movement of the membrane will allow for less alteration of the blood, leading to fewer complications,” said Carl Botterbusch, CTO of CorWave. “We are working on another version of the pump based on a tubular shaped membrane which will combine minimally invasive surgery and physiologic pumping.”
“In just a few years, the CorWave R&D team has excelled at building a paradigm changing LVAD. The next step is to further optimize the device through extensive in vitro and in vivo tests prior to the first-in-man implant,” said Louis de Lillers, CEO of CorWave.
Heart disease is a growing challenge, with over 10 million heart failure patients in the US and Europe, according to ESC and AHA. 10 per cent of patients progress to end stage heart disease, when the heart is no longer able to pump enough blood by itself. These patients have only a 25 per cent chance of surviving one year if treated with optimal drug therapy (source: REMATCH trial). A small portion of this group will receive a heart transplant, but a lack of donors means that many patients will die while waiting. A device that assists the heart can help, either in allowing them to receive a transplant or in providing additional years of active life. LVADs are devices that meet this urgent clinical need. In 2014, the LVAD market generated more than $700m (€641m) in sales with over 7,000 patients receiving an LVAD. 60,000 to 200,000 people could benefit from the implant as the clinical outcomes improve.
Organised alternately by Paris Pitié Salpêtrière (Pr Leprince), Bad Oeynhausen HDZ-NRW (Pr Gummert), and Berlin DHZB (Pr Falke), EUMS is a leading European scientific event focusing on LVAD and Total Artificial Hearts (TAH) gathering key opinion leaders from across the world.