News | Leads Implantable Devices | May 13, 2019

BioTrace Medical's Tempo Lead Obtains CE Mark for Temporary Intracardiac Pacing

Temporary pacing lead designed to reduce intraprocedural complications following TAVR and TMVR

BioTrace Medical's Tempo Lead Obtains CE Mark for Temporary Intracardiac Pacing

May 13, 2019 — BioTrace Medical Inc. 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’s design, featuring novel retractable stabilizer loops and a soft tip, mitigates the risks of dislodgment and perforation and ensures stability during rapid pacing.

In a U.S. multi-center retrospective study1 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.2

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,3 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.

For more information: www.biotracemedical.com

References

1. 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

2. 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

3. 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

Related Content

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
Overlay Init