BIOTRONIK is making available in the U.S. its Solia S ProMRI MR conditional pacing lead, the smallest such product available in the market. It’s only 5.6 French wide and comes in 45, 53, and 60 cm lengths. The device has a polyurethane coating on top of silicone to make sliding through vessels easier. It also features a soft distal end that was designed to cause less irritation to heart tissue.
Main outcomes of the last phase of the SIELLO clinical study which involved 1,758 patients, according to BIOTRONIK:
- Primary endpoint one: 100 percent 12-month event-free rate for patients with an atrial Solia lead
- Primary endpoint two: 99.6 percent 12-month adverse event-free rate for patients with a ventricular Solia lead
- Primary endpoint three: 100 percent rate of successful sensing and pacing at 12 months for patients with one or two