Biotronik has launched its Solia S ProMRI, with a 5.6 French lead body. According to a company release, this is the smallest MR-conditional pacing lead available in the USA.
Solia S ProMRI is available in 45, 53 and 60 centimetre lengths.
Solia received US Food and Drug Administration (FDA) approval on June 9, 2016 based on data collected during the Pre-Market Study (investigational device exemption) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with statistical significance:
- Primary endpoint one: 100% 12-month event-free rate for patients with an atrial Solia lead
- Primary endpoint two: 99.6% 12-month adverse event-free rate for patients with a ventricular Solia lead
- Primary endpoint three: 100% of successful sensing and pacing at 12 months for patients with one or two Solia lead
The SIELLO clinical study enrolled 1,758 patients at 60 US sites with 3,220 implanted Solia leads.
With a polyurethane coating over silicone designed to reduce friction, Solia is designed to enable easier introduction through small vessels and complex anatomy. Solia’s soft distal segment is designed to help reduce stress and minimise myocardial trauma.
“Because there is a wide range of patient anatomy types, it is necessary to have various lead lengths to ensure the best outcomes. There have been, however, limitations in the variety of leads available, so this new technology will offer a more versatile lead and improve procedures,” says Ulrika Birgersdotter-Green, director of pacemaker and ICD services at UC San Diego Health and professor of medicine at University of California, San Diego School of Medicine (both San Diego, USA).