October 27, 2016 — BioTrace Medical Inc. said it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Tempo Lead, an temporary pacing lead designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement (TAVR) and electrophysiology (EP) procedures.
Temporary leads are used in more than 350,000 procedures each year, a number that is growing rapidly as the population ages and TAVR becomes increasingly common. The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker allowing a physician to monitor and control a patient’s heart rate for up to several days.
The design of conventional temporary pacing leads can cause serious complications, BioTrace said. Current temporary leads can be easily dislodged from the heart, which may result in loss of pacing, with serious consequences for the patient. As a result, patients are often limited to bed rest for the duration of temporary pacing lead placement, delaying ambulation and thereby increasing length of stay in costly hospital units such as intensive care. In addition, current leads risk perforation of the heart wall, which may lead to pericardial effusion and tamponade, leading to potentially life-threatening cardiac compression.
BioTrace Medical’s Tempo Lead incorporates innovations designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures. The Tempo Lead features a novel active fixation mechanism, bipolar electrodes and a soft tip. An elastomeric balloon may be inflated to aid passage of the lead through the venous vasculature and into the right ventricle, and aids in orienting the lead.
“The Tempo Lead represents the first major advance in temporary pacing since the technology was introduced decades ago,” said Susheel Kodali, M.D., director of the Heart Valve Program at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York. “As a critical component of every TAVR procedure, temporary leads are integral to successful clinical outcomes for patients. I am excited about the potential of this technology and look forward to using it in my practice.”
Results of the first-in-human study of the technology will be presented at the annual Transcatheter Cardiac Therapeutics (TCT) conference in Washington, D.C. on Sunday, Oct. 30, at 10:59 a.m. eastern time in Room 209, Level 2.
“FDA clearance is an exciting milestone for BioTrace,” said Laura Dietch, CEO of BioTrace Medical. “We are pleased to bring this important innovation to the significant and growing number of patients needing better temporary pacing options to minimize risks and life-threatening complications. We look forward to launching in select U.S. centers in the coming weeks.”
For more information: www.biotracemedical.com