Transseptal

Transseptal puncture is an important technique that allows catheterization of the left atrium and left ventricle. Transseptal puncture is now widely performed during procedures in pediatric cardiology, interventional cardiology, and cardiac electrophysiology. The risks associated with transseptal puncture have been well recognized, with a complication rate of approximately 1% even when performed in high-volume institutions. The most serious complications are related to inadvertent puncture of structures other than the atrial septum, particularly the aortic root, coronary sinus, and the posterior wall of the right atrium.

Transseptal puncture is generally performed under fluoroscopic guidance, which provides excellent spatial resolution and visualization of the catheter/needle assembly but has a limited ability to resolve soft tissue. The safety of transseptal puncture can be improved by various methods. The IRIS Transseptal catheter is designed to use direct visualization of the atrial septum as one such method. (1)

The IRIS Transseptal catheter incorporates an expandable hood with an integrated camera and working lumen through which a transseptal needle can be deployed. As described in the Journal of Cardiovascular Electrophysiology article, Voyage Medical completed a preclinical series at the Massachusetts General Hospital and later concluded a clinical trial, demonstrating the utility of direct visualization for guiding transseptal puncture.*

* This device is in the development stage and the Company has not yet applied to the FDA for marketing approval.

1. Thiagalingam, A., , D’Avila, A., Foley, L., Fox, M.,  Rothe, C., Miller, D., Malchano Z.,Ruskin, J. N., and Reddy, V. Y. : Full-Color Direct Visualization of the Atrial Septum to Guide Transseptal Puncture. J Cardiovasc Electrophysiol 2008:19:1310-1315