Company’s Tempo Temporary Pacing Lead Has Been Used in More Than 1,500 Procedures with No Perforations – New Standard of Care in TAVR Demonstrates Safe Ambulation and Contributes to Reduced Length of Stay
BioTrace Medical’s innovative Tempo Temporary Pacing Lead is designed for secure and stable pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures such as TAVR. The Tempo Lead’s unique design – featuring a novel retractable fixation mechanism and a soft tip – reduces the risks of dislodgment and perforation, ensures stability during rapid pacing, and facilitates patient ambulation in recovery. It is the only active fixation temporary lead available. To date, the Tempo Lead has been used in more than 1,500 U.S. procedures, with no reported myocardial perforations or other device-related adverse events.
“Fifteen hundred temporary lead placements without a perforation is quite notable,” said Susheel K. Kodali, MD, director of the Structural Heart & Valve Center at NewYork-Presbyterian Hospital/Columbia University Medical Center and Associate Professor of Medicine at Columbia University Medical Center. “The Tempo Lead continues to demonstrate its intra- and post-procedural safety as more centers adopt the technology.”
The Tempo Lead will be featured in the TCT 2018 Interactive Training Workshops titled “Improving TAVR Safety & Ambulation with the Tempo Temporary Pacing Lead” on Monday, September 24 from 8:00 – 9:30 a.m. PT and from 10:00 – 11:30 a.m. PT in the TAVR Pavilion (Sails Pavilion, Upper Level). The workshop will feature clinical presentations, case studies and hands-on rotations conducted by Stanley J. Chetcuti, MD, FACC; George S. Hanzel, MD; Nikolaos Kakouros, MD, PhD; John C. Messenger, MD; Amar Krishnaswamy, MD; Sanjeevan Pasupati, MB ChB, FRACP; Carlos E. Sanchez, MD, FACC, FSCAI; Mark Webster, MBChB, FRACP; Brian Whisenant, MD; and Steven J. Yakubov, MD.
The training workshops will highlight the performance and benefits of the Tempo Lead with a review of clinical experience with the device, including an overview of data from a recent 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. Select TAVR and non-TAVR case studies will also be reviewed, including Riverside Methodist Hospital’s experience with the use of the Tempo Lead, which demonstrated an average reduction in post-TAVR length of stay from 3.1 to 1.7 days.
The Tempo Lead will also be featured in a case presentation by Rohit Malhotra, MD (UMass Medical Center) during the Challenging Case and Poster session on Friday, September 21, from 5:00 PM to 7:00 PM in the East Side Foyer, Upper Level. Dr. Malhotra will emphasize the critical role the Tempo Lead played in a complex TAVR case that included variant venous anatomy.
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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Contacts
for BioTrace Medical, Inc.:
Health+Commerce
Sierra Smith, 480-540-4296
sierra@healthandcommerce.com
Source: BioTrace Medical, Inc.