Catheter Precision won a new 510(k) clearance that adds structural heart disease patients to the indications for VIVO, the company said November 2. The expanded labeling covers patients with structural heart disease undergoing catheter ablation for monomorphic ventricular tachycardia.
VIVO, short for View Into Ventricular Onset, is a non-invasive 3D imaging system that locates the origin of a ventricular arrhythmia before an electrophysiology procedure. It already held FDA clearance and a CE mark. Catheter Precision is a wholly owned subsidiary of Flyte Aviation (NYSE American: VJET), and the release was datelined Fort Mill, South Carolina.
Structural heart disease means scarred, damaged or enlarged tissue, which is the harder mapping problem. CEO David Jenkins said VIVO keeps the same accuracy and safety in that group, and argued that pre-procedural planning cuts procedure time.
An indications-for-use expansion off an existing predicate is the cheapest growth a small device company can buy. Whether it moves reimbursement is a separate question, and the release does not address it.