Solia received Food and Drug Administration (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:
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
Solia leads
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, Inc. “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 minimize 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.
A press release can be found from Biotronik website.
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