HEARTWARE COMPLETES EURO-ENROLMENT; AWAITING CE MARK
December 9th 2008 11:52
Friday December 5, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: ANTISENSE UP 11%, STARPHARMA DOWN 19%
* PROGEN v COUP GROUP: ROUND 2; JANUARY 9, 2009
* HEARTWARE COMPLETES EURO-ENROLMENT; AWAITING CE MARK
* PHYLOGICA ACQUIRES DYNAMIC MICROBIALS; LOSES DIRECTOR
* BIODIEM FLU VACCINE ‘MAY CONTROL PANDEMICS’
* CAPITAL GROUP CLIENT TAKES 10% OF COCHLEAR
* SOLAGRAN DIRECTOR CHARLES PELLEGRINO RESIGNS
* GOODBYE AVANTOGEN; G’DAY ACUVAX
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HEARTWARE
Heartware has completed enrolment of 50 patients for the Conformitée Européenne clinical trial of its left ventricular assist device.
The company said the 50 patients implanted with the Heartware ventricular assist device (HVAD) at five centres in Europe and Australia had been supported for an average of 250 days each.
Heartware said a total of 12 patients have received heart transplants after being supported for an average of 266 days each.
Three patients had their device removed after recovery of their heart function.
Four patients died on support within the first 180 days of their implant.
One additional patient death occurred beyond 180 days.
Thirty-one patients have successfully met the endpoint of the trial of 180 days or transplant.
A further 15 patients remain on support but have yet to reach the 180 day endpoint.
Heartware chief executive officer Doug Godshall said that with 50 patients implanted in the trial, representing a cumulative support period of 35 years, “we are becoming increasingly confident of the performance of this device given our positive early clinical data”.
He said that at the International Society for Heart and Lung Transplantation conference in April this year Dr Georg Wieselthaler presented data from Heartware’s first 23 patients, showing a survival to endpoint of more than 90 percent.
“It is pleasing that this unusually high rate of success continues to hold true over the larger patient group, particularly in light of the relatively small number of transplants that have occurred,” Mr Godshall said.
Heartware’s application to apply the Conformitée Européenne (CE) Mark to the Heartware System was based on data from the first 25 patients and the data was presently under independent clinical review.
Heartware said it reiterated its expectation “that CE Mark will be granted in the weeks ahead”.
Previously, Heartware said it expected CE Mark approval by the end of 2008.
Today Heartware told Biotech Daily that the company still expected that to be the case, but if approval was delayed by the Christmas holiday period, approval would be by mid- January 2009.
With the completion of the trial, Heartware said its two core areas of focus were to manage the company’s US clinical trial and, in parallel, to drive an effective commercial launch and subsequent rollout in Europe and Australia following receipt of CE Mark.
Heartware was unchanged at 50 cents.
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