St. Jude Medical has implanted first patient with its Accent Magnetic Resonance Imaging (MRI) Pacemaker and Tendril MRI Lead systems in the investigational device exemption (IDE) MRI study.
The Accent MRI pacemaker which is based on the company’s Accent RF Pacemaker platform streamlines the device implant procedure and follow-up appointments, and enables consistent home monitoring by eliminating the need for any patient interaction with automated daily device checks.
The Tendril MRI Lead body has a co-axial design and Optim outer insulation, a silicone-polyurethane co-polymer material, which provides improved durability, flexibility and contributes additional handling characteristics and control during implant procedures.
The IDE study is a randomised clinical trial evaluating the safety and efficacy of the Accent MRI system and Tendril MRI Lead in patients with standard bradycardia (a heart rate that is too slow) who are indicated for a pacemaker.
All patients in the study will be implanted with pacemaker and lead and followed for 12 months post-implant to assess the acute and chronic performance of the system.
In addition, the study will determine if patients with the devices can safely undergo full-body, high resolution MRI scans to better accommodate the medical needs.