STRUCTURAL INTERVENTIONS

AMPLATZER™ DUCT OCCLUDERS CLINICAL DATA

Designed for flexibility, our innovative duct occluder options conform to a variety of duct sizes while achieving complete patent ductus arteriosus (PDA) closure from a pulmonary or aortic approach.

AMPLATZER™ DUCT OCCLUDER PDA CLOSURE CLINICAL DATA 

The Amplatzer™ Duct Occluder was evaluated in a multi-center, non-randomized, pivotal study evaluating the clinical performance for PDA closure in 435 patients.1

ACUTE PROCEDURE SUCCESS*99.2%
6-MONTH COMPLETE CLOSURE98.4%
12-MONTH COMPLETE CLOSURE98.6%
SERIOUS AND MAJOR ADVERSE EVENTS1.3%

*Of the number of patients where the device was attempted, those who successfully received a device.

AMPLATZER™ DUCT OCCLUDER II PDA CLOSURE CLINICAL DATA

The safety and efficacy of the Amplatzer™ Duct Occluder II were evaluated in a single-arm, multicenter study in 192 patients aged 6 months to < 18 years. The device was successfully implanted in 92.7% of patients, with complete closure in 98.2% of successful implantations. Serious adverse events were reported in 1.6% of patients.2

The study found that implantation was simple and the ability for retrograde aortic delivery revealed a statistically significant reduction in fluoroscopy time and therefore procedure-related radiation exposure.3

CLICK HERE TO LEARN ABOUT
AMPLATZER PICCOLO™ OCCLUDER
CLINICAL DATA

LEARN MORE

MAT-2201735 v2.0 | Item approved for OUS use only.

Copyright © 2024 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, U.S.A.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product 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.

MAT-2000631 v17.0 | Item approved for OUS use only.

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

+