Therapy Areas: Devices
East End Medical awarded FDA clearance for SafeCross Transseptal RF Puncture And Steerable Balloon Introducer System
14 July 2021 -

Medical device company East End Medical reported on Tuesday the receipt of the US Food and Drug Administration's (FDA) clearance for its three in one SafeCross Transseptal Radiofrequency (RF) Puncture & Steerable Balloon Introducer System for a predictable and safe solution for electrophysiology and structural heart interventions requiring left atrial access.

The company added that the three in one system includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (RF) puncture dilator, which delivers electrical energy quickly and predictably to puncture the atrial septum.

According to the company, the SafeCross System's contrast-filled positioning balloon is ultra-visible under echocardiography and x-ray to facilitate precise puncture site selection, while the bi-directional steerable introducer sheath allows for safe maneuvering and perpendicular placement on the septum.

Easily compatible with the available electrosurgical generators, the company's SafeCross System can be adopted into clinical practice.

From the period 28-31 July 2021, the company's SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System will be on display at booth 1361 at the Heart Rhythm Society (HRS) meeting in Boston, MA.