St. Jude Medical ($STJ) has had a difficult couple of weeks, battling Dr. Robert Hauser over a study questioning the safety of its Riata defibrillator leads, particularly when compared with Medtronic's ($MDT) Quattro Secure offering. This morning the company says it's advancing a different device, which also pits St. Jude against rival Medtronic.
St. Jude touted the start of its Accent MRI pacemaker and Tendril MRI lead IDE study. The goal: to see if patients with these devices can safely undergo full-body, high-resolution MRI scans. Medtronic also has an offering that allows patients with pacemakers to undergo MRIs. However, the Revo system's use is limited to certain patients and specific areas of the body. Last year, the FDA signed off on the St. Jude rival starting a study of its Advisa DR MRI.
The company also notes that roughly 1 million people are implanted with pacemakers worldwide. Just under one-third of those patients could benefit from scans of the major organs and bones in the thoracic region of the body during the lifetime of their devices, so this new offering could prove critical for them.
The study will take place at up to 80 centers worldwide and will enroll approximately 800 patients.
Also today, the company announced the launch of the Trifecta aortic stented, pericardial tissue valve. The first procedures were performed at Osaka University Hospital and Saitama Medical University International Medical Center. Doctors there have heralded the approval. "The smaller valve is more suitable for Japanese patients, and also offers exceptional hemodynamic performance, which allows it to perform more like a natural heart valve," explained Prof. Yoshiki Sawa of the Osaka University Hospital.
- see the St. Jude release on the trial start
- and here's the statement on the Trifecta launch