VenstraMedical: Development of a Transcatheter Blood Pump System

BioMedTech Horizons Program: VenstraMedical - Development of a Transcatheter Blood Pump System

Each year in Australia approximately 57,000 people experience acute coronary events including heart attacks or unstable angina, with around 12 per cent of those being fatal¹. It remains the leading single cause of death in Australia².

This article is an extract from the: MTP Connect - BioMedTech Horizons Program - Impact Report (August 2023)
BioMedTech Horizons Program - Impact Report (August 2023): A summary of the progress and impact of new Australian medical technologies supported by the BMTH Program (2017–2023). BMTH Rounds 2, 3 & 4.
+ Download the Full Report: Download

Three to 10 per cent of heart attack victims develop cardiogenic shock – the top cause of death for those who have a heart attack – and may benefit from use of a circulatory support device, such as a stent or a pump to help circulate blood, reducing the pressure on the heart.

Patients admitted to Intensive Care Unit (ICU) for cardiogenic shock in Australia have a mortality rate of 40 per cent, which is five times higher than other causes of ICU admission (3,4). Mortality rates have not significantly improved for these patients in over 20 years, despite the introduction of a range of new treatments and devices. Venoarterial extracorporeal membrane oxygenation (VA-ECMO), for which there is a state-wide referral system in New South Wales, only services the sickest one per cent of patients experiencing cardiogenic shock.

There remains an unmet need for interventions supporting heart attack patients that are more effective, more accessible, and reduce patient trauma.

Aiming to fill this void, Newcastle-based cardiovascular medical device company VenstraMedical has acquired an intellectual property (IP) portfolio and rights to all technical proof-of-concept development efforts for a percutaneous ventricular assist device (pVAD).

A pVAD is a small blood pump placed at a catheter tip, implanted by a cardiologist into the patient’s heart to provide temporary cardiac support. Though the pVAD market is well established in the US and growing, next-generation devices that are small enough for rapid non-surgical implantation are required to provide full cardiac support.

The Venstra system is designed to be the world’s smallest and most powerful catheter-based heart pump compared to existing approved pVADs. It will be used to treat patients at high risk due to cardiogenic shock, or those undergoing high-risk coronary interventions – enabling clinicians to alter the disease course at an earlier stage, thereby potentially transforming outcomes.

The Venstra system is unique due to the collapsibility of the pump, which is expanded upon deployment – allowing for a minimally invasive insertion process and reduced trauma to the patient. It can be implanted quickly on an emergency basis and still provide full cardiac unloading. The system includes an external software-controlled power unit that drives the pump via a magnetic coupling and allows the clinician to monitor and set operational parameters.

The objective of VenstraMedical’s BioMedTech Horizons (BMTH)' project was to develop and technically de-risk the Venstra system. In particular, the team aimed to develop the pump and external console parts to further assess the feasibility of the patented collapsible/expandable pVAD. It also planned to mature the company with the addition of key people and processes.

With input from a medical advisory board that included Australian and US cardiology key opinion leaders the team developed comprehensive user needs for the implantable pVAD pump, the drive system and fluid purge system that are part of the external console.

An iterative design and computational testing process were conducted with project collaborators at The University of Queensland, enabling rapid prototyping and validation. Subsequent in vitro validation on assembled prototypes showed performance met expectations as set by the medical advisory board, giving great confidence for the team to move ahead.

The team completed multiple Freedom to Operate studies and formulated three new patents, two of which were lodged during the project period. With new IP and existing IP in multiple jurisdictions, extensive market research completed through the development phase and a clear understanding from the US Food and Drug Administration (FDA) of the clinical and regulatory requirements to validate its product, VenstraMedical made significant strides in the commercialisation of its product.

As a result of the work completed through the BMTHsupported project, VenstraMedical raised both a seed round ($2.4 million, June 2021) and, based on development progress, a Series A round ($11.4 million, January 2023) with the Australian Unity Future of Healthcare Fund being an investor co-leading the round.

Though the Venstra system still requires further development, a major milestone will be achieved with first-in-human clinical use in Australia. It is anticipated that clinical studies will be required for both key indications of use, high-risk percutaneous coronary intervention [PCI] and cardiogenic shock.

VenstraMedical’s Co-Founder and Chief Medical Officer, Dr Suku Thambar, added that the company’s work will advance the view that Australians are at the cutting edge of medical device innovation and development.

“By developing the world’s smallest and most powerful catheter-based heart pump, compared with existing approved pVADs, VenstraMedical will save lives and healthcare costs and will put Australia on the map for medical device innovation,” he said. This will result not only in thousands of lives saved, but also reduce infarct size and heart damage, resulting in less heart failure in the community. This will in turn lead to fewer hospitalisations, lower hospital costs and a reduced burden on the healthcare budget.

Excitingly, because of the work undertaken to develop the pump during the BMTH project, VenstraMedical has now commenced the console development with the world-class Design+Industry (D+I) team in Sydney, which will lead to increased manufacturing jobs in Australia and millions of dollars in income.

According to D+I’s Project Manager Paul Scopes, the Venstra system represents a ground-breaking advancement in the field of cardiac support.

“It is a remarkable technological leap and we do not know of any other approved device with this capability in the market,” he said. “Once introduced, the device has the potential to make a global impact. The project itself will demonstrate the ability for a highly complex Class III medical device to be developed in collaboration with multiple parties across Sydney, Newcastle and the US, highlighting the fantastic capabilities Australia, and in particular New South Wales, has to offer.”

To lean more, visit venstramedical.com and design-industry.com.au

Key Contacts:

Martin Cook
CEO & Co-Founder, VenstraMedical
Connect on LinkedIn

John-Paul Daneel
Design + Industry
Connect on LinkedIn

1. Australian Institute of Health and Welfare. Heart, stroke and vascular disease: Australian facts.
Source: https://www.aihw.gov.au/reports/heart-stroke-vascular-diseases/hsvd-facts/contents/all-heart-stroke-and-vascular-disease/coronary-heart-disease
2. Australian Bureau of Statistics.
Source: https://www.abs.gov.au/statistics/health/causes-death/causes-death-australia/latest-release#australia-s-leading-causes-of-death-2021
3. Acute Heart Failure - The AU and NZ Experience, 2018.
Source: https://intensivecarenetwork.com/acute-heart-failure-the-australian-and-new-zealand-icu-experience/
4. Temporal trends in incidence and patient characteristics in cardiogenic shock following acute myocardial infarction from 2010 to 2017: a Danish cohort study, 2019.
Source: https://onlinelibrary.wiley.com/doi/10.1002/ejhf.1566

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