Medtronic Inc announced the first United States implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system and the start of a new clinical trial of the company's newest generation cardiac resynchronization therapy (CRT) device for high-risk heart failure patients. At the same time, the company also announced the start of a clinical trial for the Medtronic Attain Bipolar, OTW (over-the-wire) left-heart lead.
The first implant of the InSync III Marquis device took place at the Mid America Heart Institute of Saint Luke's Hospital in Kansas City, Missouri in a 46-year old woman with a history of severe heart failure and sarcoidosis, a condition in which the heart muscle becomes infiltrated with inflamed cells that cause poor contractility. The procedure was performed without complications in two and one-half hours by Brian Ramza. David Steinhaus, is the principle investigator of the study at St. Luke's and the medical director of the Mid America Heart Institute.
"This device combines the best of the InSync III and the InSync Marquis systems, with important new functions that are designed to improve the effectiveness of cardiac resynchronization therapy," said Ursula Gebhardt, vice president and general manager of Medtronic's Heart Failure business.
The InSync III and the InSync Marquis devices were approved by the U.S. Food and Drug Administration earlier this year, and the InSync III Marquis combines the best of both systems. At just 38cc and 77 grams, the device offers bi-ventricular pacing that is designed to be programmed to pace the two lower chambers of the heart independently. It also has new features that are designed to help maintain cardiac resynchronization during episodes of atrial fibrillation, the most common arrhythmia, and provide monitoring capabilities for managing patients' heart failure status.
In addition, the InSync III Marquis system includes the advanced therapies of today's most prescribed implantable defibrillator, the Marquis DR ICD, which rapidly detects and terminates fast ventricular heart rates. InSync III Marquis also adds the unique Medtronic Patient Alert feature, which warns patients with a series of tones when follow-up care is needed, and other features designed for termination of rapid heart rhythms.