Biotrace Medical’s Tempo leadBioTrace Medical has announced the first commercial use of the company’s Tempo temporary pacing lead since US Food and Drug Administration (FDA) 510(k) clearance in October 2016.
The first cases involved patients undergoing transcatheter aortic valve implantation (TAVI) procedures and were performed by James Harkness, interventional cardiologist, and Brian K Whisenant, medical director of the Structural Heart Disease Program at Intermountain Medical Center in Salt Lake City, USA, and Susheel Kodali, director of the Heart Valve Program at Columbia University Medical Center/New York Presbyterian Hospital, New York City, USA.
BioTrace Medical’s Tempo Lead is for use in procedures in which temporary pacing is indicated, including TAVI 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.
“I am pleased to now have an innovative new option for temporary pacing for my patients,” says Whisenant. “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.”
“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,” says Martin B Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York Presbyterian Hospital, and a member of BioTrace Medical’s Scientific Advisory Board. “The Tempo Lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.”
According to a company release, the Tempo Lead features a novel active fixation mechanism, bipolar electrodes and a soft tip.
Safety and efficacy results of the first-in-human study of the Tempo Lead were presented in October at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, USA. The multi-centre study clearly 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.