Biotronik said today it launched its Solia S ProMRI 5.6 Fr magnetic resonance imaging conditional pacing leads in the U.S., touting them as the smallest available on the market.
The newly launched leads, available in 45, 53 and 60 centimeter lengths, were approved last week based on data collected from the pre-market study phase of its 1,758-patient Siello clinical study.
“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. 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,” prez Marlou Janssen said in a press release.
The company touted data from the trial that led to its FDA approval, reporting a 100% event-free rate at 12 months for patients with an atrial Solia lead, a 99.6% rate of freedom from adverse events at 12-months for patients with a ventricular Solia lead and a 100% rate of successful sensing and pacing at 12 months for patients with 1 or 2 Solia leads.
“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,” Dr. Ulrika Birgersdotter-Green of the University of California, San Diego School of Medicine said in a prepared statement.
The Solia leads are designed with a polyurethane coating over silicone designed to reduce friction and allow for easier introduction through small vessels and complex anatomy, the company said.
Yesterday, Biotronik said it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease.
Data from the Biosolve-II trial of the stent was previously published in The Lancet, the company said, and 1-year data examining the safety of the device was recently published in The European Heart Journal.
