Johnson & Johnson's Biosense Webster Initiates First-in-Human Use of Investigational Laminar LAAX System for Stroke Risk Reduction in NVAF Patients

Mar 01, 2024 09:44 CST Updated 09:44

Biosense Webster

Developer of Diagnostic and Therapeutic Devices for Arrhythmia

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

Source of the article:Heart NotCome;Editor:Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Under Johnson & JohnsonCommitted toResearch and Development of Electrophysiology Interventional Diagnosis and Treatment ProductsProfessional Medical Device CompanyBiosense WebsterAnnounce,As part of its key Investigational Device Exemption (IDE) study, the initiation ofFirst CaseApplication in Patients with Non-Valvular Atrial Fibrillation (NVAF)Research-based Left Atrial Appendage Occlusion (LAAX) System。

This prospective, randomized, controlled, multi-center, open-label pivotal clinical study will recruit 1,500 patients across up to 100 sites in the United States. Patients with NVAF who are considered suitable for using LAAX to reduce the risk of stroke and systemic embolism will participate in this research.

▲Image SourceOfficial CompanyNetwork

The StudyComparison of the Safety and Effectiveness of the LAAX System with Commercially Available Left Atrial Appendage (LAA) Closure Devices, providing potential non-pharmacological alternatives for eligible patients.

The company said in a press release that it was performed by Saibal Kar (Los Robles Health System, Thousand Oaks, USA) and Devi Nair (St Bernard's Heart & Vascular Center, Jonesboro, USA).The First Batch of Surgeries Marks an Important Milestone in Innovative Solutions for Non-Valvular Atrial Fibrillation (NVAF) Treatment。

# Major Company Events

On November 30, 2023, Johnson & Johnson Medical Technologies (the medical device business segment under Johnson & Johnson) announcedCompleted the acquisition with a prepayment of 400 million US dollars (approximately 2.84 billion RMB)Focused on developing innovative technologies for left atrial appendage (LAA) closure in non-valvular atrial fibrillation.Laminar Company(Founded in the United States in 2019).

Johnson & Johnson stated that the $400 million figure might be slightly adjusted, and additionally, the company will pay extra milestone payments based on Laminar's clinical and regulatory performance after the acquisition.Laminar to Be Integrated into Biosense Webster, a Johnson & Johnson Subsidiary Specializing in Cardiac Electrophysiology。

The Laminar LAA developed by Laminar is completely different from the Boston Scientific Watchman series and Abbott's Amplatzer Amulet.Laminar LAA Eliminates the Left Atrial Appendage Through "Rotational Motion" Rather Than Occlusion。Laminar LAA is expected to avoid the drawbacks of traditional left atrial appendage occluders.(such as thrombosis, leakage, lifelong use of anticoagulants, etc.).

# Executive Evaluation

The study'sChief Researcher Kar"Los Robles is the primary recruitment site for the U.S. Early Feasibility Study (EFS),The LAAX system is aInnovative Methods for Eliminating LAA"It's exciting to be able to participate in this research that turns the latest technological advancements into practical solutions for treating patients. I look forward to seeing the results of this U.S. clinical trial."

Nair He is also the principal investigator of the clinical trial and added, "I am very pleased to be involved in the clinical trial of this new laminar flow device. Stroke is a major concern for millions of patients with atrial fibrillation, and as doctors, we strive to provide better outcomes for these patients."

Vice President of Scientific Affairs, Cardiovascular & Professional Solutions, Johnson & Johnson Medical TechnologiesJennifer CurrinHighlighted the potential of this innovative technology: "Based on the positive evidence from the early feasibility study, we believe that the Laminar LAAX System hasMay Transform Patient Care by Providing a Viable Alternative to Long-Term Blood Thinners"We look forward to learning more about how this innovative left atrial appendage closure method compares to currently available solutions."

# Left Atrial Appendage Closure Market Size

Today,Globally, approximately 38 million patients suffer from atrial fibrillation (AFib)., the left atrial appendage (a small pouch-like附属物) in patients with atrial fibrillation is prone to thrombosis., Clinical studies have shownMore than 90% of thrombi in patients with atrial fibrillation are related to the left atrial appendage.After a thrombus forms in the left atrial appendage, it will travel through the bloodstream to organs throughout the body. If the thrombus blocks an artery in the brain and obstructs blood flow, it can cause ischemic stroke, commonly known as "stroke."Patients with atrial fibrillation have more than five times the probability of having a stroke compared to ordinary people.

Therefore, the American College of Cardiology (ACC), the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS)It is recommended that patients with atrial fibrillation should undergo left atrial appendage occlusion before concurrent cardiac surgery.。

In 2022, the global left atrial appendage closure device market size reached 14.469 billion yuan (RMB), and the market size of left atrial appendage closure devices in China reached 3.327 billion yuan. It is expected that...By 2028, the global market size for left atrial appendage closure devices will reach 80.24 billion yuan., with an estimated Compound Annual Growth Rate (CAGR) of 33.27% within 2023-2028.

The development of cardiac occluders has a long history, and the occluders for congenital heart disease have basically achieved domestic substitution in China.The left atrial appendage occluder has great room for improvement due to its late start.. Currently,The Chinese Left Atrial Appendage Occluder Market is Mainly Composed ofBoston Scientific, Abbott, Lepu Medical, LifeTech Scientific, and Shanghai PusitRepresented by five enterprises。

Since the introduction of the PLAATO occluder in 2001, percutaneous left atrial appendage occluders have emerged onto the historical stage. From the perspective of design principles, they are mainly divided into plug types and disc types. Among them, WATCHMAN and Amulet, as representatives of the two types of occluders, are the most widely used. Through clinical research and the exploration of R&D teams,Boston Scientific and Abbott successively launched the second-generation occluders WATCHMAN FLX and Amulet in 2021.Hope to improve the safety and effectiveness of left atrial appendage closure technology at the same time.WATCHMAN FLX is also recognized as the best left atrial appendage occluder currently available due to its ease of use and excellent follow-up results.。

▲Iterative Design of WATCHMAN and WATCHMAN FLX Products (Image SourceOfficial CompanyNetwork)

The 2019 European Consensus on Left Atrial Appendage Occlusion mentioned,Design Requirements for an Ideal Left Atrial Appendage OccluderYes:1. Usability.Suitable for the anatomy of the vast majority of atrial appendages, easy to operate, and a short learning curve.2. Safety. The incidence of surgical complications is low.3. Effectiveness.Physically isolate the auricle and the blood flow of the left atrium circulation to reduce the stroke rate. In the future product design,The use of deflectable sheaths, the design of anticoagulant coatings, and the optimization of mechanical frameworksThese technologies will benefit both the surgeon and the patient.

The development of left atrial appendage occluders has now entered a phase of flourishing diversity.The first-generation occluders from various companies in China are gradually taking the historical stage., China-produced occluders have also accumulated a large amount of research and practical experience through imitation and innovation. Currently, all types of occluders are undergoing intensive pre-market studies.

▲Chinese-produced Left Atrial Appendage Occluder

# Laminar Left Atrial Appendage Occlusion System

Laminar's left atrial appendage closure system can be divided into two parts, one part isDelivery system with a diameter of 18F(Through transseptal puncture to reach the left atrial appendage), as shown in the figure below:

A part ofImplant(Currently available in 12mm and 16mm sizes). The implants are divided intoHead (Ball)AndLock (Lock) Two PartsAfter the implant reaches the left atrial appendage through the delivery system, the doctor rotates the "head" of the implant to close the left atrial appendage, then secures it with a "locking mechanism" to complete the surgery.

The size of the lock and ordinary blocking fabrics comparedMuch smaller。

Specific Surgical Operation DemonstrationSee the video below, translation for reference:

Laminar About this occlusion systemThe pivotal study has received FDA approval., the study is planned to begin enrollment in early 2024. Previously, the early feasibility study of this set of equipment covered 45 patients. The trial results were published inJACC: Cardiovascular Interventions In the journal,Fifteen patients had no safety issues within 12 months post-surgery and successfully achieved closure of the left atrial appendage at 45 days.。

President of Biosense WebsterJasmina Brooks"Laminar's innovative approach will expand our product portfolio in this high-growth market and strengthen our electrophysiology and echocardiography businesses."

Jasmina Brooks

About Biosense Webster

Biosense Webster is a company formed by Johnson & Johnson in 1996 after acquiring Cordis Webster for $1.8 billion and Biosense for $400 million.Specifically responsible for Johnson & Johnson's electrophysiology businessAt that time, Cordis Webster's core products, catheters and angioplasty balloons, helped further enrich Johnson & Johnson's cardiac stent product line. Biosense, on the other hand, was the company that launched the world's first 3D cardiac electrophysiological mapping system, established by Harvard University in 1993.

The company's products are divided into six categories:3D Navigation System, Diagnostic Catheter, Therapeutic Catheter, Ultrasound Equipment, Interventional Devices, Generator。

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