MENLO PARK, Calif.–(BUSINESS WIRE)–BioTrace Medical, Inc., the leader in innovative temporary pacing technology, today announced the company’s key activities at the Transcatheter Valve Therapies (TVT) structural heart disease summit, which will take place June 20-22 at the Sheraton Grand Chicago.
The company’s Tempo® Temporary Pacing Lead will be featured in a New Technology Forum discussion titled “Improved Temporary Transvenous Pacers: The BioTrace Tempo Lead,” presented by Steven Yakubov, M.D., System Chief, Advanced Structural Heart Disease at Riverside Methodist Hospital/OhioHealth.
The discussion will highlight the performance and benefits of the Tempo Lead with a review of U.S. clinical experience with the device including an overview of recent data from a multi-center U.S. retrospective study. That study further demonstrated that the Tempo Lead is safe and effective for temporary cardiac pacing, provides stable peri- and post-procedural pacing support, and facilitates post-procedure ambulation. He will also review select case studies, including Riverside Methodist Hospital’s experience with the use of the Tempo Lead, which demonstrated an average reduction in length of stay from 3.1 to 1.7 days.
In addition, results of a single-center retrospective study of 112 patients demonstrating the safety and efficacy of the Tempo Lead will be presented by Daniel S. Menees, M.D., of the Michigan Medicine Cardiology Clinic | Cardiovascular Center at the University of Michigan. Dr. Menees notes that the Tempo Lead facilitated post-procedure ambulation with 90% of patients with the lead left in post-procedure ambulating.
The Tempo Lead will also be discussed as a potential solution to complications resulting from permanent pacemakers following TAVR as part of a presentation by Tamim Nazif, M.D., of NewYork-Presbyterian/Columbia University Medical Center.
Details of presentations and events at TVT 2018 featuring the BioTrace Tempo Lead are below (all times are Central Time):
TVT Hot Topics: TAVR I
Thursday, June 21
Session 2: Significant Procedural Complications After TAVR
Incidence, Predictors and Consequences of New LBBB and New Permanent Pacemakers After TAVR
10:10 a.m.; Chicago Ballroom X
- Presented by Tamim Nazif, M.D., NewYork-Presbyterian/Columbia University Medical Center
TVT New Technology Forum: TAVR I
Thursday, June 21
TAVR Accessories, Part 3: Pacemakers and Valvuloplasty
Improved Temporary Transvenous Pacers: The BioTrace Tempo Lead
11:00 a.m.; Sheraton Ballroom II-III
- Presented by Steven Yakubov, M.D., FACC, FSCAI, Riverside Methodist Hospital/OhioHealth, Columbus, Ohio
TVT Moderated Poster Session
Thursday, June 21
Post-TAVR Utilization of a Novel Active-Fixation Temporary Pacing Lead
11:00 a.m.; Promenade, Ballroom Level, 4th Floor
- Presented by Daniel S. Menees, M.D., University of Michigan
About BioTrace Medical’s Tempo® Temporary Pacing Lead
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 such as TAVR. The Tempo Lead was cleared by the Food and Drug Administration (FDA) in October 2016 for use in all temporary pacing applications including: TAVR, reversible symptomatic bradycardia support, and interventional procedures such as alcohol septal ablations, pacemaker infections/extractions, and generator changes. The Tempo Lead is the only active fixation temporary pacing lead available in the U.S. Its unique design, which includes a novel active fixation mechanism, bipolar electrodes, and a soft tip, mitigates the risks of dislodgment and perforation, which are common complications associated with conventional temporary pacing leads.
Results from a multi-center retrospective analysis of 224 U.S. interventional cardiac procedures including transcatheter aortic valve replacement (TAVR), 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.
About BioTrace Medical
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. For more information, visit www.biotracemedical.com.
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