Abbott's Next-Generation Amplatzer Talisman PFO Occluder Gains NMPA Approval for Stroke Prevention

# Disease Background

The foramen ovale is a physiological channel left over from the embryonic period of the atrial septum of the heart. Around 5 to 7 months after birth, the secondary septum and primary septum of the atrial septum adhere and fuse together in most people to form a permanent atrial septum. If they fail to fuse, a permanent crack-like abnormal channel will remain in the fossa ovalis, which is called patent foramen ovale (PFO).

The incidence of PFO in the general population is 22%-38%.Clinical studies have shown that PFO is associated with a variety of clinical conditions, including cryptogenic stroke, transient ischemic attack (TIA), migraine, decompression sickness, and cardiac-systemic circulation paradoxical embolism, among others.

Numerous studies both in China and abroad have shown that, compared with drug therapy alone,PFO closure can benefit patients with ischemic stroke, transient ischemic attack, or systemic embolism who have a PFO, and can better reduce the risk of recurrent stroke.。

# Amplatzer TalismanPFO Occluder

▲Image SourceFrom the company's official website

Amplatzer TalismanIt is optimized based on the Amplatzer PFO Occluder technology.In addition, all Talisman PFO occluders are pre-connected to the delivery cable, reducing the preparation time for doctors.ReportedlyAbbott's Most Advanced and User-Friendly PFO Occluder to Date。

Amplatzer TalismanYesFully Recyclable and Repositionable, thereforeCan ensure the occluder is positioned optimally.Amplatzer Talisman has four models.，All four models can pass through an 8F or 9F guiding sheath.。

Product features are as follows：

（1）Preloaded Design Enhances Operational Efficiency:Talisman is preloaded with a delivery cable, facilitating clinical operation by the surgeon, saving time in installing the occluder disc, and offering more convenient one-step operation.

（2）Upgrade Instrument Transmission with Trevisio Delivery System: Talisman, paired with the latest generation delivery system Amplatzer Trevisio, benefits from the excellent toughness and elasticity of Trevisio cables, ensuring no edge lifting occurs during occluder deployment.

（3）New model specifications are closer to clinical applications.:Talisman adds 9-PFO-3025 specification, with a right atrial disc diameter of 30mm and a left atrial disc diameter of 25mm, offering better adaptability to common anatomical structures.

（4）Right disc inverted design, tightly fitting the atrium:Talisman The right disc of the occluder is designed in an inverted shape, which makes it fit more closely to the atrial septum after implantation and easier to endothelialize.

（5）Increased waist size to accommodate more anatomical structures.: The thickened waist effectively prevents slippage during deployment, reduces damage to the atrial septum, and can enhance the extensibility of the waist for a better anatomical fit.

（6）Improved accessories reduce surgical risks: Improve the three-way valve and hemostatic valve, reduce air intake, avoid air embolism, and lower the risk of surgery.

（7）Reduce nickel leaching, ensure safer implantation: Exclusive Intaglio technology reduces nickel leaching by 95%, significantly lowering the risk of nickel allergy after implantation.

# PFO Occluders in China and Abroad

GORECARDIOFORM and Helex occluders are both products of GORE.Among them, the GORE CARDIOFORM Occluder is a new type of occluder, made of a nickel-titanium metal stent covered with expanded polytetrafluoroethylene material. The GORE CARDIOFORM Occluder has a smaller volume, conforms to the anatomical structure of the PFO, helps with tissue endothelialization, and increases the closure rate of the foramen ovale.

The Helex occluder is a new device used for treating ASD (atrial septal defect) and PFO (patent foramen ovale).Approved by the FDA for clinical use in 2006The structure of the HELEX occluder easily conforms to the contour of the septum without protruding into the atrium. It consists of a nitinol frame covered with a polytetrafluoroethylene membrane to reduce thrombosis.

▲GORECARDIOFORM (Left), HELEX (Right) Occluder

In terms of degradable occluders,BioSTAR OccluderIt was designed by NMT in 2006 and improved from CardioSEAL/STARFlex.The first bioabsorbable occluder, specifically designed for closing ASD and PFOIts design adopts an MP35N stainless steel frame and a bioabsorbable fabric, which is a biomaterial engineered from the submucosal layer of porcine origin.

▲BioSTAR Occluder

Shanghai Shape Memory Company, a subsidiary of Heart Technology Medical, developedMemosorb Bioresorbable PFO Occluder Uses Resorbable MaterialsStructurally, the innovative design of the patent locking edge and forming lock of this occluder ensures stable support after implantation without being affected by the movement of the septal valve, making it not easy to fall off or shift. Meanwhile, the concave double-buckle design of the disc can stably clamp the primary and secondary septums, allowing the disc to fit well with the atrial septum. The configuration of the three-layer shunt membrane on the double discs and the waist effectively blocks the PFO tunnel, reducing residual shunting.

In 2023, Xintai MedicalThe Second-Generation Fully Degradable PFO Occluder NeoSorbA multi-center clinical trial has been launched in China. The product, with its innovative structure, improved waist design, and optimized flow obstruction as its main features, is currently in the clinical selection process.

▲Memosorb (Left), NeoSorb (Right) Fully Degradable PFO Occluder

Developed independently by LifeTech Scientific CorporationIrisFIT PFO Occluder is a new type of partially biodegradable occluder., featuring a dual-disc structure. An articulated connection between the two discs allows for better adjustment of the spacing thickness to reduce pressure between the occluder and the tissue. The left disc employs a unique weaving technique, reducing the use of metallic materials and thereby decreasing the thrombosis rate in the left atrium.IrisFIT PFO Occluder Entered the Special Approval Process for Innovative Medical Devices, Known as the "Green Channel," in 2016, Is Currently in Clinical Trials, and Is Expected to Be Launched in 2024.。

▲IrisFIT PFO Occluder

Pansy® is a product developed by Shanghai Jinkui Medical.Self-expanding biodegradable occluder, with improvements in shaping, resilience, and support. It has good biocompatibility, harmless degradation products, and is absorbed within a reasonable timeframe.Pansy Biodegradable PFO Occluder Has Recently Been Submitted to the FDA for Registration and Approval。

▲Pansy Biodegradable PFO Occluder