Ventracor to benefit from US reimbursement decision

By Tanya Hollis
Friday, 03 October, 2003

A United States decision to approve reimbursement of Ventricular Assist Devices has come as good news to Australian artificial heart developer Ventracor (ASX:VCR).

US federal agency Centres for Medicare and Medicaid Services (CMS) made the decision this week to allow reimbursement of the devices in patients who were not candidates for heart transplantation.

The decision means Ventracor's left ventricular assist device could become more accessible to patients in the lucrative American health market.

"This is a significant decision and a very large step toward underpinning the market and economic drivers in the USA for left ventricular assist devices and in particular the company's VentrAssist device when approved by the FDA," said Ventracor's chief executive Michael Spooner.

The Sydney company is currently undertaking clinical trials of its VentrAssist device at Melbourne's Alfred Hospital as part of its progress toward commercialisation.

Last month, the trial's principal investigator, Prof David Kaye, announced that the second implant of the device, this time into a 76-year-old man, had been a success. Kaye also said that the first patient was continuing to do well at home.

The pilot trial is to involve some 10 patients who, while gravely ill, are not eligible for a heart transplant and are no longer responding to other medical therapies.

In the US, the CMS has determined that implantation of a left ventricular assist device approved by the Food and Drug Administration is "reasonable and necessary as permanent mechanical cardiac support" for patients with chronic end-stage heart failure who are not candidates for heart transplantation and who meet a number of other conditions.

At the time of writing Ventracor was trading 1.5 per cent lower at $2.69.

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