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BioTrace Medical's Tempo® Lead Shows Stability and Safety in Real-World Performance Consistent with Clinical Study Outcomes In TVT 2017 Presentation
[June 19, 2017]

BioTrace Medical's Tempo® Lead Shows Stability and Safety in Real-World Performance Consistent with Clinical Study Outcomes In TVT 2017 Presentation


BioTrace Medical, Inc., an innovator in the development of temporary pacing technology, today announced that the company's Tempo® Temporary Pacing Lead was featured in an oral presentation and two live cases during the Transcatheter Valve Therapies (TVT) 2017 conference in Chicago. Tamim Nazif, M.D., director of clinical services of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center, presented real-world experiences with the Tempo Lead from transcatheter aortic valve replacement (TAVR) cases.

Dr. Nazif's presentation highlighted the safety of the Tempo Lead, with real-world U.S. experience to date demonstrating no dislodgements or perforations as well as the technology's reliable pace capture during and after the procedure, facilitating earlier patient ambulation in recovery.

"Our real-world experience with the Tempo Lead is consistent with the excellent results of the New Zealand first-in-human study demonstrating the safety and reliable performance of the device," said Dr. Nazif. "The Tempo Lead may improve the safety of TAVR and other structural heart procedures by reducing complications like cardiac perforation, loss of pacing capture, and valve embolization. There may also be opportunities with the Tempo Lead to reduce the length of ICU stay, expedite recovery, and reduce permanent pacemaker implantation with a strategy of watchful waiting in patients with transient conduction disturbances."

Temporary pacing is an important and necessary adjunctive therapy to support patients undergoing TAVR procedures, but can be associated with serious complications including cardiac perforation and dislodgement with loss of pace capture. BioTrace Medical's Tempo Lead, cleared in October 2016 by the U.S. Food and Drug Administration (FDA), features a unique design that mitigates the risk of these complications and is the only active fixation temporary lead available.

Dr. Nazif presented an overview of the technlogy, highlighting three case studies from NewYork-Presbyterian/Columbia University Medical Center's use of the Lead, as well as early U.S. Tempo Lead experience in several hundred cases with no device-related adverse events, no perforations and no dislodgements. In addition, real world experience shows patients ambulating post-procedure with the Tempo Lead in place, and overall highly favorable operator feedback.

Successful Live Cases Broadcast to TVT 2017 Attendees

Additionally, Dr. Nazif and Dr. Susheel Kodali, co-director of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center, performed two live TAVR cases using the Tempo Lead, which were broadcast to attendees at TVT 2017.


"The Tempo Lead has become an important part of our TAVR practice, and I believe that due to its stability and safety the use of this innovative technology will become an important adjunct for TAVR procedures," said Dr. Kodali. "Our own experience to date has been consistent with clinical data from the first-in-human study of the device. This technology provides peace of mind, offering stable pacing both during and after the procedure."

"The clinical community has been highly supportive of the use of the Tempo Lead," said BioTrace President and CEO Laura Dietch. "We are excited that many top TAVR centers recognize the Tempo Lead's value, making it their lead of choice for TAVR procedures."

Results from a 2016 multi-center study of 25 patients conducted in New Zealand demonstrated the safety of the Tempo Lead, with no device related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations. Pacing with the Tempo Lead was successful in all treated patients with no loss of pace capture or lead dislodgement. Average procedural pace capture threshold was 0.7±0.5mA. Rapid pacing was successful in all cases with no loss of capture.

About TAVR and Temporary Pacing

Temporary leads are used in more than 350,000 procedures each year, a number that is growing rapidly as the population ages and TAVR becomes increasingly common. The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker allowing a physician to monitor and control a patient's heart rate for several days.

The design of conventional temporary pacing leads can cause serious complications. Current temporary leads can be easily dislodged from the heart, which may result in loss of pacing, with serious consequences for the patient. As a result, patients are often limited to bed rest for the duration of temporary pacing lead placement, delaying ambulation and thereby increasing length of stay in costly hospital units such as intensive care. In addition, current leads risk perforation of the heart wall, which may lead to potentially life-threatening compression of the heart.

About BioTrace Medical

BioTrace Medical, Inc., a private venture backed company based in San Carlos, 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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