surely not, page-15

Pump-maker Ventracor aware of deaths

Rebecca Urban | February 17, 2009
Article from: The Australian

TROUBLED medical device maker Ventracor was aware of patient deaths that have since been linked to the failure of its implantable heart pump at least 10 months before concerns were made public.

Ventracor last week announced a worldwide ban on new implants of its much-vaunted VentrAssist device for treating heart failure, following the death of three patients whose heart pumps had failed after the leads were damaged.

The company, which is chaired by former Qantas boss John Ward and counts director Elizabeth Nosworthy on its board, revealed that statistical analysis completed "very recently" had shown that the reliability of one of its VentrAssist devices did not meet its internal targets. The particular model has so far been implanted in 188 patients worldwide and is the subject of an investigation by the Therapeutic Goods Administration.

Although investors in the company first learned about the safety concerns on February 10, the TGA confirmed to The Australian that the company reported one death in April last year and another death last month. The third patient to have died is believed to have been overseas.

Despite the lag, the Australian Securities Exchange, whose job is to ensure public companies keep the market informed of material events, said it had no reason to believe Ventracor had not complied with its disclosure obligations. "No one is disputing the significance of the deaths. Nor taking them lightly," ASX spokesman Matthew Gibbs said.

"However, the question of 'materiality' under the listing rules may be determined in the context of the number of devices in the market, the health of the patients, and the effect on the company's financial and operational performance."

David Blake, an independent healthcare industry analyst, has queried the apparent lack of action from the ASX on the matter. "It appears that Ventracor may have misled the market by not properly disclosing some pretty serious issues relating to its product," Mr Blake said.

"Where's the Australian Securities Exchange on this? The ASX has got to be a little more diligent when it comes to companies and disclosure."

But Mr Gibbs said the ASX would continue to monitor the situation closely.

"If new information comes to light, we will take appropriate supervisory action," he said.

The debacle couldn't come at a worse time for Ventracor, which was once hailed for its local innovation and has attracted millions of dollars in government grants. Having last year failed to attract new investors to finance ongoing and costly clinical trials, the company launched a last-ditch attempt to find a buyer before it runs out of money.

However, its chances look slim after local competitor Heartware attracted a $434 million takeover bid from US medical device giant Thoratec Corp at the weekend.

Ventracor's shares have been suspended from trading for the past week so it can assess the impact of the product faults - which have so far been identified in 11 patients - on its business.

Last week it attributed the broken leads in some cases to a "failure to follow the instructions for use". A TGA spokeswoman stressed that the VentrAssist devices were used by critically ill patients suffering from heart failure who were often awaiting a heart transplant.

"The TGA is investigating whether the deaths were related to the VentrAssist device, or whether the patients died from their underlying serious cardiac condition," she said. "While this investigation is under way the company has been instructed to ensure no further VentrAssist devices are used in Australia."

Patients who have concerns regarding the device have been advised to contact their doctor.