With a commitment to advancing innovative technology to ensure people living with structural heart diseases have safe and effective treatment options, Abbott was the first to develop transcatheter edge-to-edge repair (TEER*) therapy for patients with severe mitral regurgitation (MR) and reimagined the minimally invasive treatment of aortic stenosis.
*TEER is also referred to TMVr (Transcatheter Mitral Valve Repair)
INDICATION FOR USE
CONTRAINDICATIONS
The MitraClip™ G4 System is contraindicated in patients with the following conditions:
WARNINGS
PRECAUTIONS
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip™ G4 procedure.
Indications:
The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
Contraindications:
The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.
Warnings:
Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.
Precautions:
Pre-Implantation Precautions
Implantation Precautions
Post-Implantation Precautions
Potential Adverse Events
Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to:
MAT-2011953 v3.0
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
Please be sure to read it.
The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
Are you a healthcare professional?
Test