Medtronic Wins FDA Nod for Auto-adjusting Pacemaker

The FDA has approved a new Medtronic pacemaker that automatically adjusts heart failure patients' cardiac rhythms according to their needs.

The cardiac resynchronization therapy-pacemaker, Viva CRT-P, also works for patients with atrioventricular block (AV), according to a statement by the Fridley, MN-based company. Studies showed that the pacemaker's AdaptivCRTalgorithm slashed 30-day hospital readmissions for heart failure by 47% and atrial fibrillation-related hospitalizations, emergency department or clinic visits by 55%.Heart failure is a leading cause of 30-day hospital readmissions, according to an April 2013 studyby the federal Healthcare Cost and Utilization Project.

The algorithm's trial and sub-analyses showed that it:

The pacemaker also uses diagnostic tools to identify patients at risk of readmission to the hospital.

The company also announced the first implants in a clinical trial that will compare patient and healthcare system outcomes--including patient mortality and hospitalizations--in heart failure patients who have the cardiac resynchronization therapy-pacemakers with the AdaptivCRT algorithm, versus patients receiving standard CRT. The randomized study will enroll approximately 3,000 patients worldwide, who will be followed at three and six months after randomization, and then every six months until the trial is complete.

Mark Castellani, MD, at Sparrow Hospital in Lansing, MI, and Edward J. Schloss, MD, at The Christ Hospital in Cincinnati performed the first implants. Bruce Wilkoff, MD, director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic, is chair of the AdaptResponse trial's steering committee.

Medtronic has also made significant progress in developing miniaturized cardiovascular devices. It has stiff competition from St. Jude Medical Inc. February of this year saw the first U.S. implant of Medtronic's Micra leadless pacemaker and global launch of its tiny Reveal LINQ Insertable Cardiac Monitor System.

In March, St. Jude Medical announced the first European enrollments in its Nanostim Leadless Pacemaker Observational Study as it moves forward with efforts to commercialize next-generation pacemaker technology.

St. Jude Medical, which first invested in Nanostim (Milpitas, CA) in 2011, bought the company last October for $123.5 million just after the company received the CE Mark for its device. As part of the deal, St. Jude Medical agreed to pay an additional $65 million if regulatory and sales milestones were hit.

Nancy Crotti is a contributor to Qmed and MPMN.

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