BIOTRONIK has announced the commercial launch of Solia S ProMRI, with a 5.6 French lead body, the smallest MR conditional pacing lead available in the United States. Solia S ProMRI is available in 45, 53 and 60 centimeter lengths. Solia received FDA approval on June 9, 2016 based on data collected during the Pre-Market Study (IDE) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with statistical significance:
The SIELLO clinical study enrolled 1,758 patients at 60 US sites with 3,220 implanted Solia leads.
"BIOTRONIK has a long-standing history of providing reliable leads without recall. Nearly 600,000 BIOTRONIK leads of this product family have been implanted worldwide. We've built a reputation that physicians can trust," said Marlou Janssen, President, BIOTRONIK.
"We invest significantly in innovation, but never at the expense of safety or reliability. BIOTRONIK enrolls more patients in lead studies than any other global CRM device company. We make this investment because physicians and patients deserve that level of confidence."
With a polyurethane coating over silicone designed to reduce friction, Solia enables 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," said Ulrika Birgersdotter-Green, MD, director of pacemaker and ICD services at UC San Diego Health and professor of medicine at University of California, San Diego School of Medicine.