Following the death of three patients whose heart pumps failed after damaged leads were discovered, VentrAssist has placed a worldwide ban on the device used for treating heart failure. It has been reported that VentrAssist was aware that the device, Ventracor, had been linked to the failure of its implantable heart pump at least 10 months before the problems were made public.

The company revealed that a statistical analysis recently completed showed that the reliability of one of its VentrAssist devices did not meet its internal targets. The model has 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. A third patient also died.

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."

An independent healthcare industry analyst is questioning the apparent lack of action from the ASX and says it appears that Ventracor may have misled the market by not properly disclosing some serious issues relating to its product.

The situation could not have come at a worse time as last year Ventracor, once hailed for its local innovation and boasting millions of dollars in government grants, 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 over the weekend. (https://www.dotmed.com/news/story/8208)

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.

The broken leads have been attributed, 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.

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