by Lauren Dubinsky
, Senior Reporter | June 21, 2016
BIOTRONIK announced on Thursday that the smallest MR-conditional pacing lead in the U.S., its Solia S ProMRI, is now commercially available.
The lead received FDA approval on June 9 after its safety and efficacy was demonstrated in the Pre-Market Study phase of the SIELLO clinical study. The study enrolled 1,758 patients at 60 sites in the U.S. and implanted 3,220 Solia leads.
After 12 months, 100 percent of those who received an atrial Solia lead were adverse event-free and 99.6 percent who received a ventricular Solia lead were event-free. In addition, for patients with one or two Solia leads there was a 100 percent success rate for sensing and pacing at the 12-month mark.
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"As physicians, we're focused on delivering the best possible patient care," Dr. Ulrika Birgersdotter-Green, director of pacemaker and ICD services at UC San Diego Health, told HCB News. "Cardiac innovations that help create a more personalized approach play a critical role in achieving positive outcomes."
The leads are available in three different lengths — 45, 53 and 60 centimeters. According to Birgersdotter-Green, there have been limitations in the lengths of leads available, but since patients have a wide range of anatomy types it’s important to have options.
Solia S ProMRI has a 5.6 French lead body diameter and a polyurethane coating over silicone to limit friction and make it easier for physicians to insert it through small vessels and intricate anatomy. Its soft distal segment is designed to help reduce stress and myocardial trauma.
"Patient anatomy is unique to each and every patient," she said. "For patients with small or complex vessels, complications such as vein occlusion are more likely to occur when using a lead with a wide diameter body. The smaller lead body helps maximize available blood flow and leave room for additional therapies."
BIOTRONIK’s ProMRI technology allows patients with pacemakers, implantable defibrillators, cardiac monitors and cardiac resynchronization therapy defibrillators to undergo an MR scan. According to the company, it has the broadest portfolio of MR-conditional cardiac devices on the market.
Since 2009, almost 600,000 leads in the Solia family have been implanted worldwide.
A couple of the other companies also offer MR-conditional leads. Medtronic’s Specify SureScan MR surgical leads
received FDA approval in March, which are used with its spinal cord stimulation system and Boston Scientific’s INGEVITY MRI pacing leads
scored approval in April.Back to HCB News