BioTrace Medical today released data from real-world experiences with its Tempo temporary pacing lead, touting no dislodgements or perforations and reliable pace capture during and after the procedure.
The real-world experiences as well as 2 live cases were presented during the Transcatheter Valve Therapies 2017 in Chicago this week.
In a presentation, Dr. Tamim Nazif of the NewYork-Presbyterian/Columbia University Medical Center released data from real-world experiences, including 3 cases from their Medical Center and several hundred other cases which reported no device-related adverse events, no perforations and dislodgements and an overall highly favorable operator feedback.
“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. 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,” Dr. Nazif said in a prepared release.
Results from a separate multi-center study of 25 patients demonstrated no device related adverse evetns, dislogements and sustained ventricular arrhythmia or cardiac perforations. Rapid pacing was recorded as successful with no loss of capture, the company said.
“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. 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,” Dr. Susheel Kodali of the NewYork-Presbyterian/Columbia University Medical Center said in a prepared statement.
“The clinical community has been highly supportive of the use of the Tempo Lead. We are excited that many top TAVR centers recognize the Tempo Lead’s value, making it their lead of choice for TAVR procedures,” BioTrace prez & CEO Laura Dietch said in a prepared statement.