Safety and Effectiveness of BioTrace Medical’s Tempo Lead Demonstrated in Multi-Center Analysis

BioTrace Medical Inc., a developer of temporary pacing technology, has announced positive safety and effectiveness data from a physician-sponsored U.S. study of the company’s Tempo Temporary Pacing Lead.
 
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. Procedures were performed at five prestigious U.S. centers: NewYork-Presbyterian/Columbia University Medical Center, University of Michigan Health Center, Riverside Methodist Hospital/OhioHealth, Intermountain Medical Center, and Yale New Haven Hospital.
 
“The results from this study show that physicians were able to place the Tempo Lead without any perforations, pericardial effusions, or sustained device-related arrhythmias, further proving the safety and efficacy of the device,” said Tamim Nazif, M.D., director of clinical services of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center. “These study outcomes echo the commercial experiences seen in the U.S., where the Tempo Lead has been placed in more than one thousand patients to date, with zero reported adverse events.”
 
Specific results include successful positioning and fixation in 224 patients (98 percent) by femoral (n=93, 42 percent) or internal jugular (n=131, 58 percent) venous access. Procedural mean pace capture threshold (PCT) was 0.7±0.6mA (n=213).
 
The physician-sponsored analysis further demonstrates that the Tempo Lead’s unique design facilitates safe ambulation during post-procedure temporary pacing. Tempo Lead post-procedure use (n=159, 71 percent) had a mean time of 42 hours (range of 2.5 hours to nine days) with final post-procedural PCT of 0.8±1.0mA (n=81). One hundred thirty-seven patients (61 percent) ambulated post procedure with the Tempo Lead (mean duration 45 hours, range of five hours to nine days) with stable pacing threshold (mean = 0.8±1.1mA). Stable pace capture was achieved in 99 percent of all cases.
 
The Tempo Lead is playing an important role in health systems’ efforts to reduce TAVR costs. “As part of our institution’s initiative under the Centers for Medicare and Medicaid Services’ bundled payment initiative, we sought to decrease the utilization of skilled nursing facilities and reduce hospital readmission rates,” said Steven J. Yakubov, M.D., FACC, FSCAI, system chief, Advanced Structural Heart Disease at Ohio Health/Riverside Methodist Hospital. “However, in the case of our TAVR program, our success in achieving those two goals adversely impacted a third metric of reducing hospital length of stay. The Tempo Lead allowed early ambulation and early physical therapy for post-TAVR patients, achieving a reduction in length of stay from 3.1 days to 1.7 days while still retaining our improvements in readmission rates and utilization of skilled nursing facilities.”
 
“We are pleased that the growing adoption of the Tempo Lead is also resulting in an increasing body of evidence that continues to validate the Lead’s safety and effectiveness, both intra- and post-procedure, as well as its contribution to reducing costs,” said Laura Dietch, president and CEO of BioTrace Medical. “The Tempo Lead is already migrating throughout the hospital wherever safe, stable, temporary pacing is needed. We are confident that this additional data proving its benefits will result in further adoption and growth.”
 
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.
 
BioTrace Medical Inc., a private venture-backed company based in Menlo Park, Calif., develops temporary pacing technology to improve patient outcomes and reduce hospital costs.