cable problems dating back to 2005 !

Ventracor recalls external components of VentrAssist

Helen Schuller

08/09/2005

Artificial heart company Ventracor (ASX:VCR) has recalled the external components of its VentrAssist left ventricular assist system (LVAS) following the discovery of an anomaly in certain lots of the cable which connects the externally worn controller to the implanted VentrAssist blood pump.

"It is a simple and inexpensive modification to the controller of less than 30 patients," said Ventracor CEO Colin Sutton. "We are treating this urgently - as it has the potential to cause problems we are hoping to avoid. We are half way through the Australian patients and by the end of next week hope to have changed the controller of all patents."

Ventracor is currently undertaking a global trial program aimed at the approval of VentrAssist for sale in Europe and in the US.

Sutton believes the recall will have a minor effect on the company's future milestones, "There will be delays as we rework the product but we don't believe they will be excessive but it will put under pressure the attainment of the CE trial milestone. That milestone is the recruitment of 30 CE Mark trial patients by the end of the year -- we are a lot more than half way through but we are under pressure," he said.

ABN Amro Morgan senior research analyst Scott Power is untroubled about the effects of the recall, "It's a minor bump in the road for Ventracor -- it's not helpful for the company but they are acting quickly to reduce harm to patients. Its all part of the clinical trial process."

https://www.biotechnews.com.au/article/139011/ventracor_recalls_external_components_ventrassist

And

http://news.bio-medicine.org/medicine-news-3/Ventracor-Limited-8279-1/

And

Ventracor to perform 'voluntary field exchange'

Thursday, 8 September 2005
Imelda Cotton

GLOBAL medical device company Ventracor has announced plans to perform a field exchange involving external components of its home-grown VentrAssist left ventricular assist system, an implantable blood pump for patients experiencing cardiac failure.

The Sydney-based firm has identified a potential anomaly in certain lots of the cable supplied and used in the assembly of the percutaneous lead, which connects the externally-worn controller to the VentrAssist.

The anomalies are being addressed by a simple modification to the controller, and in the interests of patient safety, Ventracor will implement a field exchange of all controllers. The move will not involve surgery or re-implantation for patients who already have the device.

The company's clinical support teams in Australia, New Zealand, the United Kingdom and the United States will implement the field action.

http://biotechnologynews.net/storyview.asp?storyid=45851§ionsource=s0&highlight=sydney