Guidant has rebuffed claims made by the New York Times that it did not disclose safety information about its heart devices because of concerns over the merger agreement with Johnson & Johnson, calling this “irresponsible and false.”
In the article, the NYT says Guidant failed to tell doctors for three years that one of its heart pacemakers had short-circuited on a number of occasions, leading to three fatalities, and claims the US Food and Drug Administration’s oversight of the cardiac devices industry is “at best, loose.” The newspaper also suggests that the problem may have been linked to Guidant’s use of a material known as polyimide – an insulating material – that can deteriorate if it is exposed to moisture.
However, Guidant argues that it has “had no reports of shorting failures which inhibit therapy as a result of polyimide degradation,” other than in those devices it recalled earlier this year [[21/06/05e]], [[20/07/05j]] – and stressed it has never withheld safety information from regulators or physicians.
This week J&J intimated it was getting cold feet over the deal, saying it is considering “the alternatives under [the] merger agreement” with Guidant. The latter’s share price has dipped significantly below the $76 dollars per share J&J originally proposed in the wake of the device recalls, and investors are now expecting that the US giant will try to renegotiate the deal or that it will unravel altogether [[20/10/05b]].
Meanwhile, Guidant has unveiled interim data from its so-called CAPTURE trial showing that its carotid artery stent can be used safely in high-risk patients by a broad range of physicians in a real-world setting. Guidant’s carotid stent, RX ACCULINK, was launched last year to treat stroke, but the FDA requested it conduct post-approval studies to confirm the stent’s performance in more patients and to assess its long-term safety and effectiveness in preventing strokes [[01/09/04f]]. This particular trial is designed to uncover rare events and is ongoing, with more than 2,800 patients currently enrolled.
