BioTrace Medical Announces Key Events Featuring Tempo Temporary Pacing Lead at TCT 2019

The company’s Tempo Temporary Pacing Lead will be featured in a breakfast symposium titled “Keeping the Rhythm with the Tempo Lead: Safety, Stability, and Ambulation for Transcatheter Aortic Valve Replacement (TAVR) and Other Cardiac Procedures,” which will be chaired by Stanley J. Chetcuti, M.D., director of the cardiac catheterization laboratory at the University of Michigan Health System, and Tamim M. Nazif, M.D., director of clinical services for the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center.

The symposium will feature recent clinical experience from several leading U.S. structural heart centers, highlighting the safety and efficacy of the Tempo Lead, its use in TAVR procedures, and its positive impact on facilitating post-TAVR patient ambulation outside of the ICU and CCU. The session will also provide an opportunity for hands-on demonstrations. (Symposium registration: https://www.crf.org/tct/program/agenda/satellite-programs?programid=1335)

On Thursday, September 26, Dr. Nazif will discuss NewYork-Presbyterian/Columbia University Medical Center’s experience using the Tempo Lead during his presentation titled “Conduction Disturbances After TAVR: Current Thinking and Clinical Relevance.”

The Tempo Lead will also be utilized during live case broadcasts from NewYork-Presbyterian/Columbia University Medical Center on Friday, September 27.

Additionally, the company announced the publication of the results of a U.S. multi-center study of 269 cardiac procedures, predominantly TAVR, in Catheterization and Cardiovascular Interventions. The results confirm the Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation.¹ The Tempo lead was successfully positioned and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no safety events, including perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place post-procedure in 189 patients (71.6%) for a mean duration of 43.3 ± 0.7 hours with a final mean PCT of 0.84 ± 1.04 mA. With the Tempo lead in place, 159 of 189 patients (84.1%) mobilized from bed to chair at a minimum, and 134 patients (70.8%) ambulated without any restrictions related to the pacing lead. There were no lead dislodgments or loss of pace capture events for this group of 189 patients.

The study included procedures performed at six leading U.S. centers: NewYork-Presbyterian/Columbia University Medical Center, University of Michigan Health Center, Riverside Methodist Hospital/OhioHealth, Cleveland Clinic Heart & Vascular Institute, Intermountain Medical Center, and Yale New Haven Hospital.

Since receiving FDA clearance, the Tempo Lead has been used in more than 4,500 U.S. procedures with a safety and performance profile superior to conventional temporary leads, including a 0.04% cardiac perforation rate and a 0.04% dislodgment rate with loss of pace capture.²

The BioTrace Tempo Lead will be featured in the following presentations and events at TCT 2019 (all times are Pacific Time):

Breakfast Symposium
Thursday, September 26
Keeping the Rhythm with the Tempo Lead: Safety, Stability, and Ambulation for TAVR and Other Cardiac Procedures
Time/Location: 6:30 a.m. - 7:45 a.m.; Room 207, Level 2, Moscone South

Co-Chairs:

• Stanley J. Chetcuti, M.D., University of Michigan Health Center, Ann Arbor, MI
• Tamim M. Nazif, M.D., NewYork-Presbyterian/Columbia University Medical Center

Faculty:

• Daniel S. Menees, M.D., University of Michigan Health Center
• Carlos E. Sanchez, M.D., Riverside Methodist Hospital/OhioHealth

Oral Presentation
Thursday, September 26
TAVR Indications and Complications
“Conduction Disturbances After TAVR: Current Thinking and Clinical Relevance”
Presenter: Tamim M. Nazif, M.D.
Time/Location: 4:20 p.m.; The Moscone Center, Room 155/157

Live Cases
Friday, September 27
NewYork-Presbyterian/Columbia University Medical Center
Times/Locations:

• 8:45 a.m.; Main Arena II
• 10:30 a.m.; Live Case Transmission Theater III
• 2:00 p.m.; Live Case Transmission Theater IV

About the Tempo Temporary Pacing Lead

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 TAVR and TMVR, accelerating recovery times, and enabling patient transfer directly to a step-down or telemetry unit instead of an ICU or CCU. With US FDA clearance and CE certification, the Tempo Lead is the only active fixation temporary pacing lead available in the world. The Tempo Lead’s unique design – featuring novel retractable stabilizer loops and a soft tip – mitigates the risks of dislodgment and perforation and ensures stability during rapid pacing.

About BioTrace Medical

BioTrace Medical, Inc., a private venture-backed company based in Menlo Park, California, is dedicated to reinventing temporary pacing to improve patient outcomes and reduce hospital costs. For more information, visit www.biotracemedical.com.

¹ Nazif TM, Chen S, Codner P, et al. The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions. Catheter Cardiovasc Interv. 2019;1–6. https://doi.org/10.1002/ccd.28476
² Company data on file as of September 2019.

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