BioTrace Medical touts small study of Tempo temporary pacing lead
BioTrace Medical tout a 25-patient, 1st-in-human study of its Tempo temporary pacing lead, designed for use during TAVR procedures, balloon aortic valvuloplasty or electrophysiology procedures.
The study showed a 92% rate of successful positioning and no device-related adverse events, dislodgments, sustained ventricular arrhythmias or cardiac perforations. Pacing was successful in all patients with no loss of pace capture or lead dislodgment; average procedural pace capture threshold was 0.7±0.5mA. Rapid pacing was successful in all cases with no loss of capture.
BioTrace said the FDA granted 510(k) clearance last week for the Tempo device and that it plans to have it on the U.S. market immediately.
“The results of this 1st-in-human study of the technology demonstrate that the Tempo Lead is safe and effective for temporary cardiac pacing, and provides stable peri- and post-procedural pacing support,” co-principal investigator Dr. Mark Webster, of the Auckland City Hospital in New Zealand, said in prepared remarks. “Durable and stable procedural and post-procedural pacing is critical to the success of TAVR, and other clinical scenarios requiring temporary pacing.”
“The Tempo Lead represents an important advance that could help reduce serious complications associated with temporary pacing,” added co-principal investigator Dr. Sanjeevan Pasupati of Hamilton, New Zealand’s Waikato Hospital. “The technology is easy to use and offers secure placement. The secure placement of the Tempo Lead alleviates the need for patients to return to the cath lab for repositioning and aids early mobilization of patients with confidence.”
“This clinical data is a significant validation of the Tempo Lead, and a gratifying milestone for our company, which was founded with the mission to improve patient outcomes and minimize risks from life-threatening complications during and after cardiac procedures,” BioTrace CEO Laura Dietch said. “As the need for temporary pacing continues to grow, especially in TAVR procedures, we are pleased that with our recent FDA clearance more patients now have a revolutionary option that may allow them to ambulate sooner, which could reduce length of stay in intensive care and decrease hospital costs.”
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