Germany-based medical technology firm Biotronik has introduced a new Solia S ProMRI conditional pacing lead in the US.
With a 5.6 French lead body, Solia S ProMRI is available in 45cm, 53cm and 60cm lengths.
The US Food and Drug Administration (FDA) approved Solia depending on data of the pre-market study (IDE) phase of the Siello clinical study.
The study recruited 1,758 patients at 60 US sites with 3,220 implanted Solia leads.
Featuring polyurethane coating over silicone, the Solia allows easier introduction through small vessels and complex anatomy.
ProMRI technology allows patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) to undergo an MRI scan.
Biotronik president Marlou Janssen said: "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 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."
Last month, Biotronik launched new CardioMessenger Smart portable monitoring device in the US.
CardioMessenger Smart, which is about the size of a modern smartphone, keeps pacemaker, implantable cardioverter defibrillator (ICD) and insertable cardiac monitor (ICM) patients connected to their physician remotely.
Image: Biotronik’s Solia is the smallest MR conditional pacing lead available in the US. Photo: courtesy of BIOTRONIK SE & Co.KG.