BioTrace Medical’s Tempo Lead Obtains CE Mark for Safe, Secure Temporary Intracardiac Pacing

BioTrace Medical Inc., developer of temporary pacing technology, announced the company’s Tempo Lead has obtained CE Mark certification in Europe for use in cardiac procedures requiring temporary intracardiac pacing.
 
BioTrace Medical’s Tempo Temporary Pacing Lead is designed for safer, more secure and stable pacing to reduce intraprocedural complications, including perforation and valve embolization. In addition, the Tempo Lead allows patients to ambulate sooner after procedures such as transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR), accelerating recovery times, and enabling patient transfer directly to a step-down or telemetry unit instead of an ICU or CCU. Cleared by the U.S. Food and Drug Administration (FDA) in October 2016, the Tempo Lead is the only active fixation temporary pacing lead available in the world. The Tempo Lead’s design— featuring novel retractable stabilizer loops and a soft tip—mitigates the risks of dislodgment and perforation and ensures stability during rapid pacing.
 
“Obtaining CE Mark for the Tempo Lead is another significant milestone for the BioTrace Medical team,” said CEO Laura Dietch. “Since receiving FDA clearance, the Tempo Lead has been used in more than 3,000 U.S. procedures with a safety and performance profile superior to conventional temporary leads.¹ The Tempo Lead is quickly becoming the standard of care for fast-growing procedures like TAVR. We credit the success of the Tempo Lead to its clinical benefits over traditional temporary pacing leads—improved patient outcomes due to decreased complications. We are pleased the Tempo Lead’s advantages are also helping improve economic outcomes for hospitals and allows them to efficiently utilize scarce resources especially in the ICU.”
 
In a U.S. multi-center retrospective study² of 269 patients led by Columbia University Medical Center and presented at the American College of Cardiology’s Annual Scientific Session in 2018, the Tempo Lead was successfully placed in 98.1 percent of the cases with no cardiac perforations, pericardial effusions, or sustained device-related arrhythmias and only a 0.8 percent loss of pace capture. The Tempo lead was left in place post-procedure in 71.6 percent of the cases, of which 84.1 percent mobilized out of bed while maintaining stable pace capture with no dislodgment. The study confirmed the Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation, which can safely allow direct transfer to step-down or telemetry units with no ICU time required, reducing length of stay.³
 
In addition, the Tempo Lead allows watchful waiting after procedures, potentially avoiding permanent pacemaker implantation in patients with transient conduction disturbances that may resolve on their own with time. The European Society of Cardiology cardiac pacing guidelines recommend a seven-day period of clinical observation to assess the type and significance of disturbances before permanent pacemaker implantation,⁴ a period of time in which the need for safe and stable temporary pacing allowing ambulation is even more important. These benefits are increasingly significant as TAVR procedures expand to intermediate and low-risk patients.
 
The design of conventional temporary pacing leads can cause serious complications, including perforation of the heart wall, which may lead to potentially life-threatening compression of the heart. Additionally, conventional leads can easily dislodge from the heart, often resulting in loss of pacing with serious consequences for the patient. As a result, patients are routinely limited to bed rest for the duration of temporary pacing, delaying ambulation and thereby increasing length of stay in costly hospital units such as intensive care.

BioTrace Medical Inc., a private venture-backed company based in Menlo Park, Calif., is dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs.

References
¹ Company data on file, as of April 2019.
² Nazif, T et al. Analysis of the Initial United States Experience with the BioTrace Tempo Temporary Pacing Lead in Transcatheter Aortic Valve Replacement (TAVR) and Other Cardiac Procedures, Journal of the American College of Cardiology, Volume 71, Issue 11, Supplement, 2018, Page A1285, ISSN 0735-1097, https://doi.org/10.1016/S0735-1097(18)31826-6
³ Yakubov SR. TCT 2017: How to Manage Conduction Abnormalities and Pacemaker Implantation (temporary and permanent) After TAVR. November 1, 2017, https://www.tctmd.com/videos/how-to%C2%85-manage-conduction-abnormalities-and-pacemaker-implantation-temporary-and-permanent-after-tavr.f1c14ee9364243e0abd8e604545cda07
⁴ Michele Brignole et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy, European Heart Journal (2013) 34, 2281–2329 doi:10.1093/eurheartj/eht150