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Event – US approval for HeartWare’s heart pump could spur company to dominance

Date October 01, 2012

US approval of HeartWare’s left ventricular assist device, the HVAD, expected in the next few weeks, could see the Framingham, Massachusetts company gain more than half the worldwide pre-transplant market from the current leader,  Thoratec, by 2016.

JP Morgan analysts predict that  HeartWare will capture 34% of the US pre-transplant patient population in 2013, and 56% by 2016. This would be a good showing from the smaller company;  Thoratec has a market cap of $2bn compared with  HeartWare’s $1.3bn. In future, however, these positions could be reversed.

A cure for heartache

Left ventricular assist devices (LVADs) aid blood circulation of heart failure patients. HeartWare’s HVAD was approved in Europe in 2009 as a bridge-to-transplant (BTT) therapy: it is used to keep patients alive until a heart transplant becomes available. Thoratec’s device, called the HeartMate II, was CE marked in Europe as BTT in 2005, followed by US approval three years later.

This wider availability has seen Thoratec secure 78% of the worldwide LVAD market, according to analysts at Bank of America Merrill Lynch;  HeartWare has just 20%.

But all that is set to change. The HVAD received a positive approval from an FDA advisory panel in April this year, and though no date for approval was given by the agency, the device is now widely believed to be on track for an autumn approval as BTT.

Final destination

The plot thickens: BTT is not the only use to which LVADs may be put. Thoratec’s device has already secured approval in both the US – in 2010 – and Europe – in 2005 – as destination therapy, meaning that it may be implanted in patients too sick to undergo transplantation. These patients will rely on the device for the rest of their lives.

HeartWare was approved for use as destination therapy in Europe earlier this year, but is some way off from gaining access to this patient population in the US as its pivotal trial is set to report in May 2014.

But when the HVAD hits the US for BTT this year, it is expected to succeed. As a sign of its promise, HeartWare has carved out a significant chunk of the European market with the device, despite it being four years behind  Thoratec’s product as BTT and two years behind as destination.

In the second quarter of this year, HeartWare’s non-US total pump share was 53%, according to analysts at JP Morgan – despite  HeartWare stating that HVAD is available in just 56 hospitals  across 18 countries. “HeartWare’s ability to capture meaningful market share with limited resources and a smaller selling organisation bodes well for its outlook in the US,” the analysts wrote.

Another thing that might boost uptake of the HVAD is the fact that the HeartMate II was subject to a US recall earlier this year. Whilst the device was not taken off the shelf, the FDA warned of a defect in a component called the bend relief, which slides over the graft carrying blood from the pump to the aorta to prevent it bending, was prone to becoming detached; the regulator published new instructions for securing the component.

Nonetheless, given that the Thoratec product has been shown to have a potentially fatal design flaw,  HeartWare's pump may gain preference among US cardiologists.

Analysts at JP Morgan predict that  HeartWare’s worldwide BTT share will reach 50-55% in 2016. With the worldwide LVAD market forecast to grow at around 15% per year up to 2016, there is everything to play for.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com

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