SAN CARLOS, Calif.--(BUSINESS WIRE)--BioTrace Medical Inc., an innovator in the development of temporary pacing technology, today announced positive clinical results from a study of the company’s Tempo® Lead designed for use in procedures in which temporary pacing is indicated.
Safety and efficacy results from 25 patients requiring temporary pacing during procedures for transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), or electrophysiology (EP) procedures were presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. by co-principal investigator Mark Webster, M.D., cardiologist at Auckland City Hospital in Auckland, New Zealand.
Results from the multi-center study clearly demonstrated the safety of the Tempo Lead, with no device related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations. The device was successfully positioned in 23 (92%) patients, with two patients having unsuitable anatomy. Pacing with the Tempo Lead was successful in all treated patients with no loss of pace capture or lead dislodgement of the device from within the heart. Average procedural pace capture threshold was 0.7±0.5mA. Rapid pacing was successful in all cases with no loss of capture.
“The results of this first-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,” said Dr. Webster. “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,” said Sanjeevan Pasupati, M.D., cardiologist at Waikato Hospital in Hamilton, New Zealand and study co-principal investigator. “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.”
The Tempo Lead received U.S. Food and Drug Administration (FDA) 510(k) clearance last week and the company plans an immediate U.S. commercial release.
“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,” said BioTrace CEO Laura Dietch. “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.”
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.
BioTrace Medical’s Tempo Lead incorporates innovations designed for secure and stable cardiac pacing with the goal of reducing complications and allowing patients to ambulate sooner after procedures. The Tempo Lead features a novel active fixation mechanism, bipolar electrodes and a soft tip.
About BioTrace Medical
BioTrace Medical Inc., a 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.