Medical device maker Medtronic said Chief Executive Arthur Collins will retire in August and be replaced by President and Chief Operating Officer William Hawkins.
News of Medtronic's succession plans come as the Food and Drug Administration said the company's device to monitor the condition of heart-failure patients is safe, but the agency questioned whether it is effective.
The change in Medtronic's management is part of a succession plan put in place when Collins told them of his retirement plans several years ago, the company said
although he will remain as chairman until August 2008
Collins, 59, has been with Medtronic since 1992. He was named CEO in 2001 and became chairman in 2002. He will continue to hold the chairman post until August 2008.
Separately, the Food and Drug Administration reviewers said they will ask a panel of advisers who meet on Thursday to interpret data on a Medtronic
Medtronic had previously disclosed that its main study of the Chronicle Implantable Hemodynamic Monitoring System missed the primary goal of reducing heart failure-related hospitalizations and emergency room and urgent care visits.
Interpreting some of Medtronic's other effectiveness analyses "may be difficult" because they were done after the study concluded, FDA reviewers said in a summary released on Wednesday.
The FDA staff said they would ask the advisory panel to evaluate Medtronic's data before voting on whether to recommend approval for the device. The FDA will make the final decision but usually follows panel recommendations.
Agency reviewers also said it "appears there is a slight trend toward reduced survival" in patients treated using the device but acknowledged that the finding was based on a small number of patients.
Medtronic, in a separate summary also on the FDA Web site, said "the evidence generated over the last eight years support the favorable clinical impact" of the device in reducing heart-failure complications.
The Chronicle IHM, about the size of a pacemaker, is implanted in the upper chest with a sensor attached to the heart's right ventricle. The device measures pressure inside the heart, body temperature, physical activity and heart rate.
Patients place an external monitor with an antenna over the chest to collect data for transmitting to a Web site where doctors can retrieve it.
The idea is to alert doctors to early signs of fluid and pressure build-up in moderate to severe heart-failure patients before symptoms appear. If the readings look worrisome, doctors could adjust medications or recommend dietary changes. The device itself provides no therapy.
More than 5 million Americans have heart failure, a chronic condition in which the heart has trouble pumping blood. The condition leads to nearly 1 million hospitalizations per year, Medtronic said.