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Flexible Percutaneous Portal Becomes Firm To Facilitate Endocardial And Intravascular Surgical Procedures
Andy C. Kiser1, Charles Love
2.
1St Clair Health, Presto, PA, USA,
2Neptune Medical, Burlingame, CA, USA.
BACKGROUND: Percutaneous endocardial cardiac surgical procedures are hindered by limited stability and control within the heart. A novel technology, which enables transcatheter devices to shift between flexible and firm states, creates a stable endovascular base to precisely access and intervene upon high-value cardiac structures.
METHODS: A uniquely designed endocardial system utilizing this platform technology provides distinctly stable and precise access to the heart chambers, valves and great vessels. This system enters the heart in a flexible, relaxed state, conforming to the intracardiac anatomy with minimal cardiac distortion. When desired, the operator shifts the endocardial system into a stable, fixed state, whereby the system becomes firm while preserving optimal cardiac anatomy, pathway and position. From this stable base, the operator may deliver a number of interventions with an unprecedented degree of precision: 1. Delivery of intracardiac devices (e.g. valves, rings, appendage technologies); 2. Surgical interventions (e.g. valve repair, ablation, gene therapy delivery); 3. Aspiration of intracardiac and pulmonary emboli. Left heart applications, specifically mitral valve repair, have been studied in the living porcine model and in cadavers. Additionally, preclinical evaluation in porcine and cadaver models culminated in FDA IDE approval for a right heart application (pulmonary embolectomy).
RESULTS: Left-sided access via transeptal and transaortic approaches in beating porcine hearts (Figure 1) and cadaver models enabled edge-to-edge suture placement in the mitral valve leaflets and annulus using a steerable suture delivery device supported by this endocardial system. Cardiac hemodynamics remained stable with limited distortion of ventricular anatomy. For right-heart applications, over 10 patients across the US and Europe have undergone acute pulmonary embolectomy in the SPIRARE I and II trials with no device related adverse events reported.
CONCLUSIONS: This innovative technology provides a stable base for precise and controlled access to difficult-to-reach intravascular targets, enabling percutaneous access for endocardial procedures traditionally performed via cardiotomy. Early clinical results of the SPIRARE trials demonstrate feasibility and patient safety. Encouraging early animal and cadaver investigations provide evidence that this technology offers the potential for controlled and repetitive access to the mitral valve and other important intracardiac structures.
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