Cardiac Septal Defect Closure Group

ACUMARK Sizing Balloon Catheter

The ACUMARK Sizing Balloon Catheter is a precision cardiovascular sizing device designed for accurate measurement of cardiac and vascular defects during interventional procedures. Engineered with an ultra-thin and highly flexible TPU balloon membrane, the system provides a low-profile design that minimizes vascular trauma while ensuring smooth navigation through the vasculature. The catheter features a soft tapered tip compatible with 0.035-inch guidewires for atraumatic vessel entry and enhanced procedural control. Three integrated radiopaque marker bands positioned within the balloon allow physicians to precisely locate, visualize, and measure cardiovascular defects under fluoroscopic guidance, improving procedural accuracy and device selection during structural heart interventions. Available in multiple balloon sizes with high inflation capacity and optimized shaft configurations, the ACUMARK Sizing Balloon supports efficient and reliable defect assessment in congenital and structural cardiac procedures.

Aegisy™ Vena Cava Filter

The Aegisy™ Vena Cava Filter is an advanced inferior vena cava (IVC) filtration system designed to provide effective pulmonary embolism (PE) protection while supporting deep venous circulation restoration. Engineered with an asymmetric lantern configuration, the filter delivers highly efficient clot filtration while maintaining desirable vena cava patency and minimizing vessel trauma. The system features a precise spiral-release deployment mechanism that enhances positioning accuracy and procedural control during implantation. Constructed from highly biocompatible Nitinol with laser-cut fatigue-resistant technology, the Aegisy™ filter offers safe and reliable long-term performance in venous intervention procedures. Designed for both femoral and jugular access approaches, the filter supports flexible implantation and retrieval options with a high retrieval success rate, including retrieval up to and beyond 14 days after placement. Its low-profile delivery sheath, secure anchoring mechanism, and optimized retrieval design help improve procedural efficiency and patient safety in the management of venous thromboembolic disease.

Cera™ Occluder Series

The Cera™ Occluder Series is a comprehensive family of transcatheter occlusion devices designed for the minimally invasive treatment of congenital and structural heart defects, including ASD, VSD, PDA, PFO, and related septal abnormalities. Engineered with a proprietary Titanium Nitride (TiN) coating over a self-expanding nitinol wire mesh framework, the Cera™ series enhances long-term biocompatibility, reduces metallic ion release, accelerates endothelialization, and minimizes thrombus formation risks. The device portfolio incorporates PET and PTFE membrane technologies to improve occlusion performance, reduce residual shunting, and provide secure anatomical sealing in complex cardiovascular defects. Designed for precise anatomical adaptation, the Cera™ Occluder family includes multiple specialized configurations such as ASD Occluders, Membranous and Muscular VSD Occluders, Eccentric and Symmetric VSD devices, PDA Occluders, and PFO Occluders, allowing physicians to select optimal solutions for a wide variety of patient anatomies and clinical conditions. With over 15,000 implanted devices and proven clinical efficacy, the Cera™ Occluder Series delivers safe, durable, and effective structural heart defect closure solutions for interventional cardiology procedures.

Cera™ Vascular Plug System

The Cera™ Vascular Plug System is an advanced embolization device designed for rapid and complete arterial and venous occlusion in peripheral vascular interventions. Engineered with a self-expanding nitinol mesh framework and proprietary Titanium Nitride (TiN) coating, the system offers excellent biocompatibility, enhanced endothelialization, and reduced thrombus formation risk for long-term procedural safety. The integrated PTFE membrane technology accelerates occlusion efficiency by reducing total occlusion time and minimizing residual shunting during embolization procedures. Designed for precise and controlled deployment, the Cera™ Vascular Plug utilizes a stainless steel microscrew connection system that enhances placement accuracy and procedural reliability. Available in a wide range of sizes to accommodate different vessel anatomies and lesion characteristics, the Cera™ Plug System provides flexible and effective embolization solutions for interventional radiology, peripheral vascular, and structural cardiovascular applications.

CeraFlex™ Occluder System

The CeraFlex™ Occluder System is an advanced family of transcatheter closure devices developed for the minimally invasive treatment of congenital and structural heart defects, including ASD, PFO, PDA, and multi-fenestrated septal defects. Designed with a highly flexible braided nitinol structure and proprietary Titanium Nitride (TiN) coating technology, the CeraFlex™ system enhances biocompatibility, reduces nickel ion release, accelerates endothelialization, and minimizes thrombus formation risk for improved long-term clinical outcomes. The innovative delivery system features 360-degree flexible rotation, precise positioning capability, lock-release deployment technology, and a pre-mounted delivery configuration that simplifies procedures and reduces operation time. Its soft and flexible delivery cable minimizes cardiac and vascular tissue trauma while allowing accurate device placement and stable release during transcatheter interventions. The flexible disc structure adapts effectively to septal anatomies, improving sealing performance and procedural reliability across a wide range of structural heart applications. Engineered for superior procedural control and enhanced implantation safety, the CeraFlex™ Occluder System provides physicians with a highly efficient and versatile solution for structural heart defect closure procedures.

Fustar™ Steerable Introducer

The Fustar™ Steerable Introducer is an advanced deflectable delivery sheath system designed to provide precise catheter navigation, enhanced procedural control, and improved access during structural heart and peripheral vascular interventions. Featuring a highly flexible steerable design with up to 160° deflection capability, the Fustar™ system enables accurate positioning and controlled device deployment in complex anatomies, including ASD, PFO, congenital heart disease, and peripheral vascular procedures. The integrated delivery sheath and guiding catheter configuration simplifies interventional workflow by reducing the need for repetitive catheter exchanges and minimizing procedure time. Engineered with smooth sheath-to-dilator transitions, coaxial navigation support, and distal silicone valve technology, the system helps reduce vessel trauma, minimize bleeding risk, and prevent air embolism during catheter advancement. Its ergonomic construction and multiple size configurations allow physicians to navigate difficult vascular pathways with greater stability and precision, making the Fustar™ Steerable Introducer an efficient and versatile solution for complex cardiovascular interventions.

HeartR™ Occluder Series

The HeartR™ Occluder Series is a comprehensive range of transcatheter defect closure devices designed for the minimally invasive treatment of congenital and structural heart diseases, including ASD, VSD, PDA, and customized multi-fenestrated septal defects. Engineered with a self-expandable double-disc nitinol mesh structure and integrated PTFE/PET membrane technology, the HeartR™ system delivers high immediate occlusion rates while minimizing long-term residual shunting and improving biocompatibility. Its modified low-profile design, shape-memory characteristics, and flexible structural configuration allow the device to conform naturally to the three-dimensional anatomy of the heart, reducing tissue stress and enhancing procedural safety. The occluder series includes specialized device variations such as ASD Occluders, Membranous and Muscular VSD Occluders, Eccentric VSD devices, PDA Occluders, and custom ASD solutions to support a broad range of anatomical and clinical requirements. Designed for stable implantation, rapid endothelialization, and reliable long-term closure performance, the HeartR™ Occluder Series provides physicians with a safe, efficient, and anatomically adaptive solution for structural heart interventions.

KONAR-MF™ Multifunctional Occluder

The KONAR-MF™ Multifunctional Occluder is a versatile transcatheter closure device specifically designed for the treatment of ventricular septal defects (VSDs) and related structural cardiac defects. Engineered with a soft woven nitinol mesh structure and elongatable waist design, the device provides excellent conformability to septal anatomies while helping reduce the risk of atrioventricular (AV) block during implantation. Its low-profile configuration is compatible with 4F–7F delivery sheaths, enabling minimally invasive procedures with reduced vascular trauma and improved procedural flexibility. The slim delivery cable and atraumatic design help minimize unwanted tissue damage while supporting smooth catheter navigation through complex cardiac anatomies. Featuring a double-sided screw connection system, the KONAR-MF™ Occluder supports both retrograde and antegrade deployment approaches, allowing physicians greater flexibility during transcatheter VSD closure procedures. Designed for safe implantation, anatomical adaptability, and reliable occlusion performance, the KONAR-MF™ system offers an effective and flexible solution for congenital heart defect interventions.

LAmbre™ Left Atrial Appendage (LAA) Closure System

The LAmbre™ Left Atrial Appendage (LAA) Closure System is an advanced transcatheter occlusion device designed for minimally invasive left atrial appendage closure in patients with non-valvular atrial fibrillation who are at risk of thromboembolic stroke. Engineered with a unique umbrella-and-cover design and patented anchoring technology, the LAmbre™ system provides stable fixation, excellent conformability, and reliable sealing across a wide variety of LAA anatomies. Its flexible low-profile delivery system, available in both single-curve and double-curve configurations, enhances procedural control and facilitates easier transseptal access during implantation. The device is designed to accommodate challenging anatomical variations while minimizing the risk of embolization and migration through secure anchoring and optimized structural stability. Clinical studies demonstrated high implantation success rates, effective closure performance, and excellent procedural safety outcomes across diverse patient populations. With its user-friendly deployment mechanism, adaptable design, and strong clinical performance, the LAmbre™ LAA Closure System offers physicians a safe and effective solution for stroke prevention in structural heart interventions.

SeQure™ Snare System

The SeQure™ Snare System is a precision retrieval device designed for the secure capture and manipulation of foreign bodies, catheters, guidewires, and implantable devices during interventional cardiovascular and endovascular procedures. Engineered for multiple-use functionality and precise procedural control, the system features a Titanium Nitride-coated tungsten loop that enhances visibility, durability, and retrieval performance during complex vascular interventions. Its flexible nitinol shaft provides excellent kink resistance and responsive 1:1 torque control, allowing physicians to navigate tortuous anatomies with improved maneuverability and stability. The optimized loop-to-shaft angle design enhances device orientation and retrieval accuracy while minimizing procedural complexity. Available in multiple loop diameters, catheter sizes, and shaft lengths, including both General and Petite configurations, the SeQure™ Snare System supports a broad range of peripheral, structural heart, and interventional radiology applications requiring reliable vascular retrieval solutions.

SteerEase™ Delivery System

The SteerEase™ Delivery System is an advanced transcatheter delivery platform designed to provide smooth navigation, precise device deployment, and enhanced procedural control during structural heart interventions. Engineered for compatibility with ASD, PFO, VSD, and PDA occluder systems, the SteerEase™ platform incorporates a PTFE-lined inner lumen to reduce friction and facilitate easier catheter advancement through complex cardiovascular anatomies. Its stainless steel braided construction improves kink resistance and structural stability, while the Pebax-coated surface enhances trackability and insertion smoothness during minimally invasive procedures. The system features specialized delivery curve configurations, including SFA-type curves optimized for ASD and PFO interventions and SFP-type curves designed for VSD and PDA delivery applications. Integrated articulating markers and platinum marker bands improve fluoroscopic visualization and positioning accuracy, while the controlled hemostatic valve helps minimize blood backflow and reduce air embolism risk. Designed for procedural efficiency, reduced vessel trauma, and precise occluder deployment, the SteerEase™ Delivery System provides physicians with a reliable and flexible solution for structural heart defect interventions.