FDA Clears BioTrace Medical's Temporary Pacing Technology for TAVR Procedures

October 27, 2016—BioTrace Medical, Inc. announced US Food and Drug Administration 510(k) clearance for the company’s Tempo Lead, a temporary pacing lead designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement (TAVR) and electrophysiology procedures.

Additionally, the company stated that results of the first-in-human study of the technology will be presented on October 30 at TCT 2016, the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

According to the company, BioTrace Medical’s Tempo Lead is 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 an 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.

In BioTrace’s announcement, Susheel Kodali, MD, commented, “The Tempo Lead represents the first major advance in temporary pacing since the technology was introduced decades ago. 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.” Dr. Kodali is Director of the Heart Valve Program at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York, New York.