Extracorporeal membrane oxygenation device combined with continuous renal replacement therapy (#2018018)

Background

Extracorporeal membrane oxygenation (ECMO), also known as extracorporeal life support, is an extracorporeal technique for providing prolonged cardiac and respiratory support to a patient whose heart and lungs are unable to provide an adequate amount of gas exchange, similar to a heart-lung machine. ECMO provides a pure respiratory support through blood oxygenation and carbon dioxide (CO₂) removal. It is a lifesaving procedure used in treating neonates, children and adults with severe, reversible, cardiopulmonary failure. Patients undergoing ECMO are generally at high risk of developing acute kidney injury (AKI) and/or fluid overload (FO). To avoid AKI and FO, renal replacement therapy (RRT) is commonly used to maintain fluid balance and metabolic control. RRT options during ECMO include peritoneal dialysis, intermittent hemodialysis, and continuous RRT (CRRT). The two most common methods to provide CRRT during ECMO are via the use of an in-line hemofilter or via a traditional CRRT device connected to an ECMO device.

ECMO and current CRRT devices operate at respectively different rates of blood flow and different blood pressures. Whereas ECMO typically operates in a relatively high range of blood flow (2-5 L/min), CRRT typically operates in a relatively low range of blood flow (100-300 mL/min). Efficient coupling of ECMO with CRRT so that they both function substantially simultaneously to provide a patient with oxygenation and removal of blood toxins and excess fluid is complex.

Renal support can also be provided by continuous venovenous hemofiltration (CVVH). This technique allows for precise control of fluid balance by providing continuous fluid, electrolyte and toxin clearance even in the absence of adequate native renal function via convective processes through a permeable membrane. The hemofiltration retains proteins and cellular components of the intravascular space and eliminates plasma water and dissolved solutes. CVVH uses the principles of ultrafiltration, hydrostatic pressure and convection to remove both fluid and solutes from the patient.

The Need

Acute kidney injury (AKI) is a frequent complication in patients receiving extracorporeal membrane oxygenation (ECMO). There is a need to combine CRRT on ECMO in critically ill patients with severe cardiopulmonary failure. The most common reasons for starting dialysis on ECMO was FO (43%), prevention of fluid overload (16%), uremia (35%), and electrolyte disturbances (4%).

The early introduction of CRRT may prevent fluid overload and is often used in clinical practice by combining both device in an provisory way.

To date, there is no device that combine both instruments – and doctors use various ways to connect a CRRT circuit onto an ECMO circuit. Each method has its advantages and disadvantages. The most commonly used RRT modality in ECMO patients is CRRT. CRRT encompass the following modalities: Slow continuous veno-venous ultrafiltration (SCVVUF), Continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF).

The Technology and Innovation

We developed a new system for blood oxygenation and purification that incorporates ECMO + CRRT.

Our new design is CRRT system, based on in-line hemofilter and only two volumetric pumps that integrate into the ECMO hydraulic circuit.

Our newly development system allows balance of blood pressures and flows between the heart and kidneys with much less machinery complexity.

Our technology relates to a controller that functions as an integrator of the signals monitored from the ECMO and from the CRRT units, and it is able to filter and recognize normal, aberrant and emergency ranges of the parameters

The idea for the development of the two-in-one renal/heart care stems from the use of a filter to filtrate blood while using extracorporeal life support machine. The main differences between the heart-lung-filter and ECMO+CRRT are the period of treatment (days vs. weeks) and the fact that the latter also allows treating renal failure not only filtration of the blood.

Our product

A new integrated system combining the CRRT and ECMO processes into one device with one controller.

Additionally, our new product concept utilizes in-line hemofilter, two volumetric pumps, one for supply of dialysate fluid into hemofilter, and the second for effluent removal.

Advantages

Our new device has several advantages:

1. More simple, fluid replacement needed only to dialysis fluid.
2. Fewer pumps used during the process, one for the blood and two pumps for the dialysis.
3. Combination of ECMO&CRRT built on a small footprint
4. Practically, this is “Slow Continuous Hemodialysis”.
5. One new controller for both devices – ECMO+CRRT.

Currently, the US Food and Drug Administration has not approved any RRT device for

use in conjunction with ECMO and such use is off label as home-made solutions.

IP Status

WO 2020/136652 – " Combined ECMO CVVH Device and Method" , Pending

The Market

The global Extracorporeal Membrane Oxygenation (ECMO) Machine market size was valued at USD  330 million in 2019 and is anticipated to generate revenues of USD 440 million by 2024 at CAGR of 4.9% over the next five years. The major factors boosting growth are the rising incidences of Chronic Obstructive Pulmonary Disorder (COPD), and surging prevalence of cardiopulmonary diseases and respiratory failures.

ECMO machine treatment is used most in patients suffering from cardiopulmonary failure or cardiogenic shock followed by patients suffering from respiratory failure. This treatment option is also used for patients undergoing a heart transplant or a lung transplant. 

The growing number of respiratory failure cases and conditions, such as cardiopulmonary disease and Chronic Obstructive Pulmonary Disease (COPD) is anticipated to boost the market growth. For instance, according to the U.S. National Center for Health statistics, in the year 2014, there were about 149,205 deaths due to chronic lower respiratory disorders in the U.S. 

Moreover, the increased adoption of ECMO machines in hospitals as a consequence of the medical community taking cognizance of the advantages related to the use of ECMO machines is anticipated to facilitate the emergence of this market during the forecast period. 

Apart from the high applicability of these appliances in hospitals, technological advancements have played a pivotal role in further accelerating the usage of these devices. For instance, Medtronic’s Century heart lung machine, which consists of an arterial pump, data management system and cardioplegia delivery system, is employed to provide cardiopulmonary functional support to patients. 

The most prominent players in the ECMO market looking forward for strategies such as new product development and technological advances in the existing portfolio.

For instance, Terumo Cardiovascular Systems Corporation has made refinements in existing technology while manufacturing their Oxygenator, Medtronic Plc designed new functions such as venous aerosols and low arterial ports, integrated into the system to enhance security and performance for patients.

Similarly, additional players are now focused on reaching new improvements in their products to gain competitive advantage in the industry: Maquet Holding B. V. & Co. KG, Medos Medizintechnik AG, Nipro Medical Corporations, Microport Scientific Corporation, Sorin Group.

The concept of combining the CRRT + ECMO has begun accelerating among the leading manufacturers of the CRRT field, and relatively considered as a large market.

When in perspective the Continuous Renal Replacement Therapy (CRRT) market is projected to reach $1.53 Billion by 2022 from $1.09 Billion in 2017, at a CAGR of 7.0%, during the forecast time frame 2017 to 2022.

Baxter International Inc. (U.S.), Fresenius Medical Care AG & Co. KGaA (Germany), Nikkiso Co., Ltd. (Japan), and B. Braun Melsungen AG (Germany) holds the leading position in the market. These companies adopted product launches, agreements, and partnerships as their business strategies to ensure their market position. Bellco S.r.l. (Italy), NxStage Medical, Inc. (U.S.), Asahi Kasei Corporation (Japan), Infomed SA (Switzerland), Medica S.p.A. (Italy), and Toray Medical Co., Ltd. (Japan) are some of the other major players in CRRT.