Highlights|magAssist Invited to Join VBData’s Live Stream on The Future is Now a Reality! Percutaneous Ventricular Assist Devices Fast-tracked for Clinical Application

On November 24, 2022, Haiqing Chen, Finance Director at magAssist, was honoured with an invitation to attend an online roundtable session entitled The Future is Now a Reality! Percutaneous Ventricular Assist Devices Fast-tracked for Clinical Application hosted by VBData. He joined discussions with guests from investment institutions and industry professionals who shared their insights and analysed the prospects of percutaneous ventricular assist devices (pVADs) on behalf of their respective companies and as individuals.

Starting with heart failure, a platform for multi-organ failure life support is under development. The main product lines initially planned by magAssist include: minimally invasive pVADs, MoyoAssist® extracorporeal ventricular assist device, next-generation portable extracorporeal membrane oxygenation system (ECMO), organ warm blood transfer platform, etc. In September 2020, a team of clinical experts led by Academician Junbo Ge officially initiated cooperation with magAssist on a pVADs project. They are integrating their medical-industrial strengths in efforts to accomplish the “last milestone” of cardiovascular intervention and jointly develop domestic upscale medical devices that serve patients with cardiovascular diseases in China and beyond. Academician Junbo Ge’s team and magAssist have jointly developed a minimally invasive pVADs which is indicated for high-risk PCI intraoperative protection. It has world-leading key performance indicators and advantages such as smaller insertion size, higher flow and lower cost.

Click to read:
Percutaneous Ventricular Assist Device Led by Academician Junbo Ge and Jointly Developed by CCI and magAssist Makes Significant Progress

Note: This article is intended as a summary of selected highlights from the live stream only. Individual wording and expressions have been adjusted for ease of reading.

Under different classifications, applicable scenarios may vary

What are the implantable VAD and percutaneous VAD products?

Haiqing Chen from magAssist:
“Artificial heart” is an umbrella term used in the industry for what is generally referred to as a ventricular assist device. These products are divided into the following categories depending on their structure and access modes.

   ·  Implantable VADs

   ·  Extracorporeal VADs

   ·  Percutaneous VADs

All ventricular assist devices essentially provide the ventricles with hemodynamic support in the form of a blood pump:

   ·  Percutaneous VADs offer a rapid and minimally invasive approach that supports a certain degree of flow and auxiliary time, primarily with minimally invasive access to the femoral artery. It is mainly indicated for the intraoperative protection of high-risk PCI and support for cardiogenic shock.

   ·  Extracorporeal VADs make multiple accesses possible with different types of intubation in order to provide support for cardiogenic shock, allowing for higher flow assistance and longer support time.

   ·  Implantable VADs involve open-heart implant surgery and are generally used as an alternative to heart transplantation in patients with end-stage heart failure. They are not quite the same as the two products mentioned above.

“We hope that the company will have a unique blockbuster product with great market potential and a portfolio of subsequent developed products, making it possible to become a platform company. In this way, a better balance will be achieved between the growth potential of the company and the R&D risk.

Simply put, in the cardiovascular or life support field, we expect the company to become a platform company with a combination of products. Of course, in the early stages of business development, we still need to focus on the development of core products.”

- Jieliang Gao, Senior Partner, CDH Innovation & Growth Capital

Blood flow, support time, body trauma

There are companies in the industry that have extended their business presence into both implantable and percutaneous VAD products. Technically speaking, what do these two products have in common? And what are their differentiated requirements?

Haiqing Chen from magAssist:
“In fact, all artificial hearts, whichever type they are, work on the same principle of providing blood support to the ventricles through blood pumps. But they do differ in product structure. While both implantable and extracorporeal VADs support blood flow through centrifugal pumps, pVADs are generally structured with axial flow pumps.

In essence, these two types of pumps can differ considerably, so the requirements for their key indicators and design objectives are not exactly the same.

Minimally invasive products cannot provide particularly prolonged blood support, but because they are minimally invasive, they can be inserted into the body quickly. Since an extracorporeal VADs can support greater flow, its access and intubation structure can be designed in a versatile way to cope with more complex scenarios and conditions.

Therefore, the situation of “one size fits all” is unlikely to occur in the artificial heart industry, in the sense that no single product can cover all scenarios or indications. This is because there are checks and balances between the three aspects of blood flow, support time and invasiveness to the body. Thus, we basically address the corresponding indications or scenarios through different products.”

Future trends in R&D - Smaller puncture point vs. larger pump head

Globally speaking, no pVAD product using an externally placed motor has been approved yet. Can you tell us why magAssist chose to pursue the route of external motor technology? In your opinion, what are the differentiators of this product?

Haiqing Chen from magAssist:
Smaller puncture points and larger pump heads are not only the core product values of pVADs, but also key elements that will unlock the market for mechanical circulatory support devices and influence clinical decisions in the future. In the U.S., a survey of Impella users among physicians showed that the predominant factors affecting utilization were insertion size, safety (vascular complications) and clinical evidence. Two out of the three are directly associated with insertion size and the other is related to size/flow.

The latest range of products from international titans are currently using the external motor approach. This is mainly because the external motor can resolve certain technical and parametric constraints caused by the built-in motor:

   ·  The optimal VAD product must achieve the right balance of flow, size (invasiveness) and support time. In the case of pVADs, if the size (invasiveness) is kept minimal, it is possible to provide some flow support, as well as acceptable hemolysis for several days of support (corresponding to PCI and CS indications).

   ·  The built-in motor is subject to the physical limitations of motor size, and cannot go below 12F.

   ·  Nevertheless, the physical limitations of motor size can be overcome by an external motor. With a smaller insertion size achieved through foldability, the impeller can be expanded to bring in a higher flow simultaneously.

In conclusion, the combination of an external motor and a foldable blood pump can achieve a smaller puncture point while making the pump head larger. This is a key point for pVADs to tap into the mechanical circulatory support device market and influence clinical decisions in the future, and will become a trend in future R&D.

Tackling the tricky part —— computational fluid dynamics + optimized miniature impellers + high-precision material technology and processes

What technical challenges do magAssist need to address regarding external motor technology? In which areas do you need to make breakthroughs? How are your products faring?

Haiqing Chen from magAssist:
First, we want to achieve “foldability”. We need to strike a balance between low invasiveness and high hemodynamics, and break the ties between insertion size and operational effectiveness; that is, opening the impeller will hopefully allow it to reach a larger size. Meanwhile, as it enters by folding, higher requirements are imposed on the high-precision material technology and processes with respect to material science. This is one of the challenging aspects to be tackled by material science.

If this problem can be overcome, it will actually be possible to increase hemodynamic support and flow to equivalent or even better levels given the smaller size and lower spin speed. As a result, mainstream market needs could be met and the technology iteration would catch up with the international standard.

Second, the flexible drive system requires high response and low power consumption so as to achieve high-speed transmission under the highly curved aortic arch. To accomplish this, we have focused on making breakthroughs in flexible drive shaft and hydraulic bearing technologies featuring optimized mechanical flexibility and wear-resistance. We are striving to eliminate the risk of placing a motor in the body and overcome size limitations, while further improving the ability to rapidly deliver treatment.

In addition, there were some problems with drift and wear caused by the external motor, as well as a number of complicated algorithms and other technical difficulties. We have overcome them one by one through the design of multi-channel conduits, deep neural network learning, etc.

Thus, we not only consider computational fluid dynamics, but also the optimization of micro-impellers and high-precision material technology and processes. This is also the most important and difficult part of the technical route adopted by international titans to solve the problems of products that have not yet entered the market.

“I do not think you can compare the two technologies of built-in and external motors in isolation; pVADs are sophisticated actively implantable medical devices. The product composition involves a variety of components and a blend of technologies, and the technical approach may be evaluated in terms of the effectiveness of the final product. It is impossible to say which one is preferred.

I would like to share a thought. The built-in motor is a well-developed piece of technology, but the external motor may make further breakthroughs possible in flow, support time, size and even cost. This is a technology direction that deserves attention.”

- Jieliang Gao, Senior Partner, CDH Innovation & Growth Capital

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