BioTrace Medical's Tempo Temporary Pacing Lead Introduced in the United States

December 19, 2016—BioTrace Medical Inc. announced the first commercial use of the company’s Tempo temporary pacing lead, which received US Food and Drug Administration 510(k) clearance in October.

BioTrace Medical’s Tempo lead is for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement (TAVR) and electrophysiology procedures. The lead is designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures.

According to the company, the first cases, which involved patients undergoing TAVR procedures, were performed by James Harkness, MD, interventional cardiologist at Intermountain Medical Center in Salt Lake City, Utah; Brian K. Whisenant, MD, Medical Director of the Structural Heart Disease Program at Intermountain Medical Center in Salt Lake City, Utah; and Susheel Kodali, MD, Director of the Heart Valve Program at Columbia University Medical Center/New York Presbyterian Hospital in New York, New York.

Dr. Whisenant commented in the company's announcement, “I am pleased to now have an innovative new option for temporary pacing for my patients. The lead reliably allows stable and secure placement, and is easy to use. The Tempo lead is the new standard of care for patients who need temporary pacemaker support.”

Martin B. Leon, MD, explained, “BioTrace’s temporary pacing leads are an exciting advance over existing technologies, which can cause complications that result in poor clinical outcomes and longer hospital stays. The Tempo lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.” Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York Presbyterian Hospital in New York, New York.

BioTrace advised that the safety and efficacy results of the first-in-human study of the Tempo lead were presented in October at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The multicenter study demonstrated the safety of the Tempo lead, with no device-related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations. The device was successfully positioned in 23 patients (92%), with two patients having unsuitable anatomy. Pacing with the Tempo lead was successful in all treated patients with no loss of pace capture or lead dislodgement of the device from within the heart, noted the company.