Suction Device for Control and Accuracy of Transseptal Access

ABSTRACT Transseptal TS access for left heart procedures is an important and rapidly growing area for diagnostics and therapy delivery with an expected total of over million U S patients In the U S and Europe TS access procedures are used for atrial fibrillation ablation left atrial appendage occlusion and patent foramen ovale closure as well as treatment of mitral valve regurgitation with the MitraClip MC Catheter positioning and device placement for MC has been challenging even for the most experienced interventionalist cardiologists ICs and has led to long procedure times with significant x ray exposure This emerging therapy necessitates a higher level of catheter stability and control over accuracy during puncture of the fossa ovalis FO If the initial puncture is inaccurate delivery of therapy is virtually impossible which often requires removal re engagement and device re advancement Thus initial localization and stabilization on the FO is critical for MC procedures to limit delivery times and x ray exposure Additionally the presence of aneurysmal or fibrotic FO and the constant movement of the heart makes standard TS access puncture unpredictable and contributes to increased risk for atrial or aortic perforation To overcome these limitations we have developed and validated the performance and utility of a novel transseptal access catheter TSAC that utilizes vacuum suction technology to provide improved catheter localization and stabilization of the FO The results of our preclinical studies were highly successful and support that through stabilization of the FO fold reduction in puncture force the TSAC reduces tenting fold to improve puncture accuracy fold compared to standard TS access devices in a clinically relevant animal model of mitral regurgitation In this Phase II application we propose an investigational device exemption IDE to conduct a human pilot study which will be used to assess primarily device safety and secondarily device feasibility in patients undergoing TS access for MC delivery To accomplish these Phase II objectives the following specific aims are proposed Final Animal Validation To assess the safety of the TSAC in a set of animals under good laboratory practice GLP conditions to be used for data submission to the FDA and institutional review boards IRBs and Human Validation To assess the contribution of human factors to feasibility in a small group of humans patients in a double arm multi center study This Phase II study addresses a highly significant national and worldwide clinical need that can impact not just NHLBI but many other mission areas of NIH Successful completion of these proposed Aims will allow us to translate our research findings to a commercially available device that could drastically improve TS access procedures and hence patient outcomes NARRATIVE The ability to achieve adequate localization and stabilization of the fossa ovalis during atrial transseptal puncture is important for numerous procedures including the delivery of mitral clips for the treatment of mitral valve regurgitation The purpose of this Phase II SBIR is to validate the ability of a novel low profile suction catheter to provide safe and accurate transseptal access to improve MitraClip delivery in a human pilot study