biotech article

Next gen approval to boost Ventracor and HeartWare

Nick Evans
Tuesday, December 04, 2007

WHILE it is not that common for companies to celebrate the regulatory approval of a rival product, heart device companies HeartWare and Ventracor have received a substantial boost this week with the news that a US Food and Drug Administration panel has recommended conditional approval for US marketing of the Thoratec Heartmate II.



HeartWare will soon start human implants of its HVAD left ventricular assist device.

The device is a "first in class" second generation axial flow left ventricular assist device, and FDA approval for Thoratec could expand the LVAD market, potentially benefiting both Australian listed companies.

Dr Ben McCaw from eG Capital said the outcome from the meeting could have a significant bearing for the VAD space across the world.

"The reason that this is important for the VAD space is that, at the moment, the number of centres that can implant the Heartmate II in the US is 40 – but if the device is approved by the FDA there are more likely to be around 100 centres in the US that could implant the device, and Thoratec have gone on record as saying that they could have the extra centres trained up within a year," he said.

"That will accelerate the growth of the market for VADs, and that should have flow-on effects for HeartWare and Ventracor."

Ventracor chief executive Peter Crosby said that the panel recommendation would boost Ventracor's position, as his company's device was testing favourably compared to the Heartmate II.

"The early clinical results of the VentrAssist compare very favourably with those of the Heartmate II and we are optimistic the US clinical trials of the VentrAssist will yield very positive results," Crosby said.

The FDA panel support for the Thoratec approval was qualified, however, with conditions outlined in the panel's recommendations related to clarifications on labelling for the device regarding small patients and those unable to be treated with anti-coagulation therapy, and elements of the post-approval study.

Background Notes

A ventricular assist device (VAD) is a mechanical pump that can be implanted to help a weakened heart pump blood through the body.

Currently, VADs have been approved for use as "bridge-to-transplant" devices, for those people whose medical therapy has failed and who are hospitalised, waiting for a donor transplant heart to become available. More recently, however, VAD devices have seen use as an alternative to transplant or as a "destination therapy".