The world market for left ventricular assist devices (LVADs) is dominated by Thoratec, which has half the European market and a 75% share in the US. But its big rival, HeartWare, is encroaching on its territory and is predicted to take over as leader within the next five years.
Thoratec’s purchase of Terumo’s preclinical-stage DuraHeart II, the world’s smallest full-capacity next-generation LVAD for $13m plus up to $43.5m in milestones is a move to turn back the invasion. The device is many years away from European and US approval, though. Thoratec will have to shell out more than $56.5m before it can reap the benefits of the buy.
DuraHeart II is a compact centrifugal flow chronic VAD using a technology Terumo calls force balance suspension, designed to minimise haemolysis, bleeding, and thrombosis, a claim that Terumo says has been borne out in preclinical tests.
Clinical trials of the device will not begin for some time – the first human implant of DuraHeart II is slated for 2016. This has not put the partners off planning its distribution; they have struck a deal under which Terumo will be the exclusive distributor of DuraHeart II in Japan and potentially other parts of Asia.
Development to that point – Thoratec is to oversee US and European clinical trials, manufacture DuraHeart II and plan distribution in the Americas and Europe – will cost. The California group says that the acquisition will add expenses, primarily related to research and development, of $6-7m in the second half of 2013. Transaction-related expenses, including the amortisation of intangible assets, will be added on top.
Thoratec must hope that the effort and expense will pay off in a market that is shifting all the time. The second half of this year will see it push its HeartMate III follow-up LVAD into clinical trials in Europe to support CE marking. HeartWare, a smaller company currently in second place, will also begin CE mark trials of MVAD, the new version of its HVAD pump which won US approval late last year (HVAD approval tempered by questions over stroke rate and sales forecasts, November 21, 2012).
The two forthcoming devices are quite different in nature, David Roman, an analyst at Goldman Sachs, says: where HeartMate III focuses on flow dynamics, MVAD is miniaturised and is intended to be easier to use. The two firms have divided the EU market fifty-fifty, and with details of the new products scant, Mr Roman is reluctant to predict any changes to this.
At least Thoratec has a concrete advantage in the US – at least for now. HeartMate II is the only device approved in the US as a way to tide patients over until they can receive a heart transplant, and also as a permanent implant in patients too sick to undergo transplantation. HeartWare’s HVAD only has approval in the former indication (Event – US approval for HeartWare’s heart pump could spur company to dominance, October 1, 2012).
But according to Bob Hopkins of Bank of America Merrill Lynch, HeartWare could increase its worldwide share to 50% or more, as Thoratec’s device must be implanted via sternotomy whereas HeartWare’s HVAD may also be placed via the less traumatic thoracotomy procedure.
Thoratec is the more powerful player in heart pumps, but the battle rages on, and it is wise to make plans for future reinforcements.
|Thoratec and HeartWare First Time FDA PMAs by EvaluateMedTech Device Classification|
|Company||Device Name||Approval Date||PMA Number||FDA Device Classification 4||FDA Product Code|
|Thoratec||Heartmate VE LVAS||September 1994||P920014||Ventricular (Assist) Bypass||DSQ|
|Thoratec||Thoratec ventricular assist device (VAD) system||December 1995||P870072||Ventricular (Assist) Bypass||DSQ|
|HeartWare||Novacor LVAS||September 1998||P980012||Ventricular (Assist) Bypass||DSQ|
|Thoratec||Thoratec Heartmate II left ventricular assist system||April 2008||P060040||Ventricular (Assist) Bypass||DSQ|
|HeartWare||HeartWare Ventricular Assist System||November 2012||P100047||Ventricular (Assist) Bypass||DSQ|