Medtronic Inc. won approval to market a new wire for use with its heart-pacing implantable devices

MondayMorning, May 11, 2009

Medtronic Inc. (Minneapolis MN) won approval to market a new wire for use with its heart-pacing implantable devices. The agency cleared the company's Attain Ability wire for treatment of heart failure. The wire, known as a lead, connects a patient's heart to a pacemaker-like device that helps synchronize irregular heart contractions. The device is surgically implanted in the upper chest. Approval of the lead is for patients at risk of heart failure, in which the heart can't adequately pump blood to the rest of the body. Sales of implantable heart devices have been mostly flat in recent years, in part because of safety concerns about leads. Medtronic, the world's largest medical device firm, pulled its Sprint Fidelis leads off the market in October 2007 after identifying several patient deaths that may have been caused by the cracked wires. Earlier this year the company updated the probable death toll to 13 patients. Those leads were used with implantable heart defibrillators, which use high-powered electrical jolts to correct irregular heart rhythms. The Attain Ability will not be used with such devices.

Elsewhere, Swiss-based Roche Holding AG was cleared to market its Avastin drug for the most aggressive form of brain cancer. The approval comes after an outside advisory panel said in March that early data for Avastin showed enough promise to be considered for quick approval for patients with an especially aggressive tumor, glioblastoma multiforme. The drug, made by its recently acquired Genentech Inc. unit, is already used to treat lung, colon and breast cancers. Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in size to warrant faster approval before the company finishes a larger trial to confirm the benefit, the panel said. Glioblastoma has seen renewed public attention since Senator Edward Kennedy was diagnosed with the malignant tumor last year. It is one of the deadliest types of cancer, with patients surviving six to 12 months after diagnosis on average, or six months without treatment. About 10,000 patients are diagnosed with the disease each year in the United States, Roche said.