Miniature implantable pump treats advanced stage heart failure

Heart failure is a complex condition with distressing consequences such as breathlessness and debilitating fatigue. For those experiencing the particular form of the problem known as heart failure with preserved ejection fraction (HFpEF – also called diastolic heart failure) the outlook is bleak. Treatment options are poor and patients frequently need hospitalisation to manage their condition. This is suboptimal for patients, clinicians and for healthcare systems picking up the tab for long-stay patients. However, all this may be about to change as a result of Pumpinheart, a breakthrough technology developed by Dr Aamir Hameed of the Royal College of Surgeons in Ireland (RCSI).

Pumpinheart will spin out from the RCSI later this year and Dr Hameed, who has a background in cardiothoracic surgery and is a lecturer in the department of anatomy and regenerative medicine, will act as chief medical officer for the spin out while the business side of the commercialisation will be led by med and ed tech entrepreneur Donald Hickey. Dr Darragh Colgan, former VP for R&D Structural Heart at Boston Scientific, will head the technical team and Dr Andrew Malone, who has been closely involved with the design and development of the Pumpinheart prototypes, will be the start-up’s CSO.

Pumpinheart is a miniature, implantable diastolic heart pump that sits in the left ventricle and supports the heart function for patients with HFpEF by reducing atrial pressure when the heart is relaxing and the chambers refilling with blood. Part two of the device is a small power and control unit which is inserted under the skin below the left clavicle. The procedure is carried out in a cath lab by an intervention cardiologist, not in an operating theatre requiring a full surgical team, and as the fitting is minimally invasive the risk of infection drops and the post-operative recovery period is short.

Roughly half of all patients presenting with heart failure have HFpEF and the addressable market for the device (as in those well enough to benefit from using it) is roughly 640,000 people between Europe and the US. However, this cohort is growing due to increased longevity, rising obesity and the number of patients surviving with cardiac arterial disease. HFpEF typically affects older adults, especially women, and common risk factors include hypertension, diabetes and coronary artery and kidney disease.

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Early funding for the project of approximately €500,000 has come from the Enterprise Ireland commercialisation fund with a further €1.8 million allocated to the company as part of a consortium supported by the Department of Enterprise, Trade and Employment’s disruptive technologies innovation fund.

The company is looking to raise €11.2 million in seed capital to prepare the product for its first temporary in-human trail, which is scheduled for 2026. Pumpinheart expects to employ roughly 12 people by year end between engineering and regulatory posts.

“Globally, there are more than 18 million HFpEF patients relying on drug therapy that does not improve mortality,” Donald Hickey says. “This lack of effective therapeutic options means there is a large unmet clinical need for Pumpinheart and our testing to date is encouraging in terms of efficacy.

“Secondly, there is a strong economic case for the device as it represents real value for money in terms of reducing the cost burden on global healthcare systems. We will target the US market initially as most HFpEF patients are over 65 years old and have health benefits based on the Medicare system there while other markets with national healthcare systems such as the NHS in the UK will also be potential customers.

“Our founding team is a strong mix of clinical, engineering and start-up experience and what unites us is a passion to bring a device to market that can help those with HFpEF to live longer active lives at home.”