Recently, the self-developed Adjustable Introducer Sheath (Registration Certificate No.: ¹úеע׼ 20263030046) from SHANGHAI OPTIPULSE BIOTECH CO., LTD, a subsidiary of Mednovo Group, has obtained market approval. This marks the 48th Medical Device Registration Certificate acquired by the Mednovo Group, signifying another step forward for the group in the field of cardiac electrophysiology.

Adjustable Introducer Sheath

This product is used in cardiovascular interventional procedures. Its distal curvature can be adjusted via a control knob to guide the insertion of catheters and other interventional devices into blood vessels and cardiac chambers. It is indicated for establishing intravascular access via the femoral vein approach during the treatment of tachyarrhythmias, guiding ablation or mapping catheters into various cardiac chambers¡ªincluding guiding catheters into the left atrium through the interatrial septum¡ªwhile also serving a protective function for the ablation or mapping catheters.

The product primarily consists of a dilator and a steerable sheath. The dilator is radiopaque. The steerable sheath is constructed from medical polymer tubing with varying levels of stiffness and excellent biocompatibility. This sheath is connected to a hemostasis valve assembly and sealing housing, with a side branch of the housing connected to a side branch flushing tube equipped with a three-way stopcock.

Product Advantages

¢ÙLarge Sheath Lumen£ºThe inner lumen of the sheath reaches 13.8F, providing ample space between the catheter and the sheath interior. This facilitates catheter rotation within the sheath and results in relatively lower friction during catheter insertion and withdrawal, enhancing procedural ease for physicians.

¢ÚHigh Sheath Strength and Controllability£ºThe curvature can be adjusted as needed by operating the control knob, allowing physicians to modify the bend during the procedure for optimal positioning. It exhibits excellent anti-buckling performance, maintaining its steerable function even under significant external force, thereby ensuring smooth procedure progression.

¢ÛClear Visualization for Positioning£º The sheath tip is equipped with radiopaque markers, enabling precise intraoperative positioning.

¢ÜStable Support£º The introducer sheath provides support and stability for the catheter, helping to prevent breakage or displacement when navigating complex anatomical pathways.

¢ÝSuperior Steering Capability£ºThe steering function is unidirectional, with a steering angle >150¡ã and a maximum achievable angle of 180¡ã. As the right inferior pulmonary vein is often close to the transseptal puncture site with limited maneuverability space, a sheath capable of forming a tight loop within the left atrium is frequently required to safely and effectively guide the catheter to the right inferior pulmonary vein.