BioTrace Medical, a company based in San Carlos, California, won FDA clearance for its only product, the Tempo temporary cardiac pacing lead. It’s intended to be primarily used for transcatheter aortic valve replacements (TAVR), positioned during the implantation and used for a number of days following to both monitor and pace the patient’s heart.
Existing devices can lose electrode contact with the cardiac tissue, leading to a difficult recovery period and potentially serious side effects. Additionally, cuts into the heart can also occur causing pericardial effusion and tamponade that can be life threatening.
The Tempo temporary lead is securely attached thanks to a novel mechanism and it uses two electrodes to pace the heart. The soft tip helps prevent perforations, while a built-in balloon can help to get the lead to its target destination and orientation within the right ventricle.
At the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. last week, data from a study of BioTrace’s Tempo lead on 25 patients was presented that showed “no device related adverse events, dislodgements, sustained ventricular arrhythmia, or cardiac perforations,” according to the company.
Product page: Tempo Lead…
Via: BioTrace…
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