Abstract: A direct visualization catheter adapted for transseptal crossing includes at least an outer member, and inner member, a transparent balloon member, and an imaging element. The outer member includes a tubular body extending from a proximal end to a distal end and defines a first lumen there through. The inner member is slidably disposed within the first lumen of the outer member and includes an elongate body with a distal end. The transparent balloon member is coupled between the distal end of the outer member and the distal end of the inner member such that the shape of the transparent balloon member is adjusted by sliding the inner member and the outer member relative to each other. The imaging element is disposed within the balloon member.

Abstract: A needle device for obtaining a tissue sample includes a distal member extending longitudinally from a proximal end to a distal end and including a distal channel extending longitudinally therethrough, the distal member formed of a first material selected to permit flexing of the distal member, a proximal member extending longitudinally from a proximal end to a distal end and including a proximal channel extending longitudinally therethrough, the proximal member formed of a second material selected to provide axial and torsional strength therealong in combination with a coupler for connecting the distal member and the proximal member, the coupler extending longitudinally from a proximal end configured to engage the distal end of the proximal member to a distal end configured to engage the proximal end of the distal member.