Cardiovascular Devices to Enjoy Soaring Revenues in the US Following Regulatory Changes

Wednesday 29 May 2013, Amsterdam

Companies producing cardiovascular medical devices in the US can look forward to an enormous surge in business, following changes to Medicare reimbursement programs, states new by analysis.

The new report states that the Transcatheter Aortic Valve Replacement (TAVR) market and Left Ventricular Assist Device (LVAD) market will both see their revenues more than double within the next six years, as a result of changes to US medical reimbursement policies.

TAVR represents a new technology, which was approved by the FDA in November 2011, with the National Coverage Determination (NCD) announced by the Centers for Medicare & Medicaid Services (CMS) in May 2012, and implemented in January 2013. TAVRs are used to treat aortic stenosis, the procedure seeing a bioprosthetic valve inserted percutaneously using a catheter and implanted in the aortic valve.

TAVR was originally approved by the FDA for use in patients with severe aortic stenosis who are deemed inoperable, but last year also saw the inclusion of high-risk patients with severe aortic stenosis deemed suitable for surgery, widening the patient pool. As a result of this, the market for TAVR in the US is expected to grow at a Compound Annual Growth Rate (CAGR) of 45%, from $238m in 2012 to $3.1 billion in 2019.

The market success of LVADs will also be driven by a developing reimbursement scenario. The NCD for Artificial Hearts and Related Devices as destination therapy was announced by the CMS on November 2010 and implemented in January 2011, and as a partial result of this, the US LVAD market is expected to more than double during the forecast period, growing at a CAGR of 15% from $362m in 2012 to $1 billion in 2019.

Ventricular Assist Devices (VAD) are attached to one or both intact ventricles of a damaged or weakened heart to assist it in pumping blood, and destination therapy in this case provides permanent mechanical cardiac support to patients with chronic end-stage heart failure, who have failed to respond to medical management and are not candidates for heart transplantation. Prior to this change, LVADS were used only for support following open-heart surgery, and as a bridge-to-transplant.