The Centers for Medicare & Medicaid Services (CMS) in the US has issued a statement indicating their proposal to increase access to ventricular access devices (VADs) for patients living with severe heart conditions, including a specific update to the criteria for treatment with a Total Artificial Heart (TAH). Leading data and analystics company GlobalData expects that the number of patients in the US treated with TAH yearly, currently standing at fewer than 300, will grow significantly if the proposed CMS coverage updates are successfully adopted as it will provide healthcare providers more flexibility and choice for treatment decisions on a patient-by-patient basis.

Ashley Young, Medical Devices Analyst at GlobalData, comments: “VADs are a clinical treatment option for the just under 6.5 million US citizens living with heart failure, as estimated by GlobalData. While heart failure currently has no cure, medications are often used to manage the disease with VADs and TAHs being one of the last options considered. However, as VAD technology continues to improve (such as through the ability to implant the devices by lateral thoracotomy rather than open heart surgery, as was recently achieved with Medtronic’s Heartware VAD), VADs are continually presenting as a better and better therapeutic option over time.”

Since the proposed CMS changes will preserve patient access for all labelled VADs currently on the market, market leaders Medtronic and Abbott Laboratories will be among the companies that most benefit from the coverage updates. Overall, GlobalData predicts that these coverage policy changes by the CMS will boost the VAD market in the US. GlobalData estimated the US market value of VADs to be just under $500m in 2019.

Young continued: “VADs are often used to treat critically ill patients and procedures cannot be delayed. Many devices associated with elective procedures in the US have been suffering amid the COVID-19 shutdowns as surgeries are cancelled. However, due to the nature of VAD use cases, this market likely will not be as deeply affected by the COVID-19 pandemic.”