Second-Generation Sheath May Facilitate Easier Access to the Inferior Veins When Treating Paroxysmal Atrial Fibrillation

MINNEAPOLIS – Medtronic, Inc. today announced Food and Drug Administration (FDA) clearance and U.S. launch of the FlexCath Advance™ Steerable Sheath, a new enhancement to the Arctic Front Advance™ Cryoballoon System. This second-generation sheath has an increased degree of deflection and response, providing greater ease compared to the previous generation in reaching the inferior veins of the heart when delivering and positioning the cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation (PAF).

The Arctic Front Advance System is used in minimally invasive procedures to isolate the pulmonary veins using coolant. Delivered via a catheter, the cryoballoon technology is associated with faster procedure times than point-by-point radiofrequency ablation^{1, 2}, and better treatment outcomes than drug therapies on the market³. Additionally, the Arctic Front Advance cryoballoon features the new EvenCool™ Cryo Technology, which optimizes the delivery of coolant inside the balloon; the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, and improves physicians’ ability to treat patients with complicated anatomies as compared to the original Arctic Front® Cryoballoon.

“The FlexCath Advance sheath’s ability to maneuver the catheter with a greater range of deflection may help reach the inferior veins and facilitate placement of the cryoballoon, which is a critical step to ensuring treatment success,” said Suneet Mittal, M.D., director, Electrophysiology Laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, NJ.

The FlexCath Advance Steerable Sheath has a deflection of 135 degrees, compared to the 90 degree deflection rate of its first-generation predecessor. This greater degree of deflection may allow the cryoballoon to be better maneuvered and positioned within the heart to achieve maximum treatment benefit. The sheath includes the following features:

• Radiopaque marker band at 5 millimeters to provide enhanced visibility under fluoroscopy;
• Deflection mechanism with an ergonomic handle that optimizes the movement of the sheath; and
• Hemostasis valve that allows for introduction, withdrawal and exchanging of catheters and guidewires, while preventing air insertion and minimizing blood loss.

“Building upon the Arctic Front System’s proven platform, the FlexCath Advance Steerable Sheath augments the overall efficiency of the procedure,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “It completes the Arctic Front Advance System and is the fourth new product we have launched in the U.S. market in two years.”

Source: Medtronic, Inc.