ABBOTT MECHANICAL HEART VALVES - CONFIDENTLY IMPLANT - Pivot Guard Design - Regent, Masters HP and Masters - Information for Europe, Middle East and Africa ONLY

Q: What is the Pivot Guard Design and what benefits does it provide?

The Pivot Guard Design offers benefits during implantation and after implantation. It shields the pivot mechanism from pannus ingrowth, minimizes interaction with sub-annular native valve apparatus in the mitral position, and helps ensure coronary ostia clearance in the aortic position.

Q: How does the brochure describe outcomes related to low INR ranges?

It reports lower thromboembolism, thrombosis, and bleeding even at low INR ranges, referencing studies such as Lowering-IT, ESCAT III, and PROACT with target INR intervals and event rates.

Q: Which mechanical valve models are included for aortic and mitral positions?

The brochure highlights Regent, Masters HP, and Masters mechanical heart valves and discusses their applicability in the aortic and mitral positions. It also notes options intended for very small patients.

Oct 28, 2026

Upload by dawugda

ABBOTT MECHANICAL HEART VALVES brochure presents Regent, Masters HP, and Masters mechanical aortic and mitral valve solutions, emphasizing confident implantation supported by the unique Pivot Guard Design. The design is described as shielding the pivot mechanism from pannus ingrowth, improving clearance for coronary ostia in the aortic position, and enabling an 85° leaflet opening angle to support smoother laminar flow. Clinical evidence sections highlight lower thromboembolism, thrombosis, and bleeding rates across low INR ranges, alongside cautionary regulatory and use instructions for Europe, Middle East, and Africa.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Proven Design

Pivot Guard Design benefits

Operate with the Facts

Lowering-IT study (target INR 1.5–2.5)

ESCAT III (target INR 1.6–2.1)

PROACT (target INR 1.5–2.0)

Solutions to Tailor Implantation

Regent, Masters HP, Masters

Cuff and Suture Options

Standard cuff, Flexcuff, Expanded cuff, PTFE

ABBOTT MECHANICAL HEART VALVES Regent, Masters HP and Masters IMPLANT CONFIDENTLY. Information contained herein for DISTRIBUTION in Europe, Middle East and Africa ONLY. Check the regulatory status of the device in areas where CE marking is not the regulation in force.©️2021 Abbott. All rights reserved. 9-EH-4-12433-01 09-2021 Rev. A AORTIC VALVE MITRAL VALVE CONFIDENTLY IMPLANT THE MOST TRUSTED MECHANICAL VALVES IN THE WORLD • 3 MILLION PATIENTS TREATED WORLDWIDE • MORE THAN 1,000 PEER-REVIEWED PUBLICATIONS • LOW THROMBOGENICITY AND EXCELLENT PATIENT OUTCOMES Information contained herein for DISTRIBUTION in Europe, Middle East and Africa ONLY. Check the regulatory status of the device in areas where CE marking is not the regulation in force.©️2021 Abbott. All rights reserved. 9-EH-4-12433-01 09-2021 Rev. A DISCOVER OUR PATIENTS' STORIES PROVEN DESIGN TO RESTORE NATIVE VALVE HEMODYNAMICS AN ABBOTT HALLMARK The unique Pivot Guard Design offers benefits both during implant and post-implant. Shields pivot mechanism from pannus ingrowth Minimizes interaction with sub-annular native valve apparatus in the mitral position and ensure coronary ostia clearance in the aortic position Enables for an 85° leaflet opening angle, minimizing leaflet flutter and leading to smoother laminar flow through the orifice* Can lessen thrombus formation by minimizing carbon surface area and thanks to the washout flow through the hinges* FIND OUT MORE ON ABBOTT MHV DESIGN 2021 ESC/EACTS GUIDELINES 1 PATIENT AGE MECHANICAL VALVE TISSUE VALVE BLEEDING EVENTS VALVE REINTERVENTION MECHANICAL EITHER VALVE TISSUE Target INR for mechanical prosthesis Prosthesis thrombogenicity Lowb Patient-related factorsa None ≥I risk factor 2.5 3.0 | Mediumc | 3.0 | 3.5 | | --- | --- | --- | | Highd | 3.5 | 4.0 | INR = international normalized ratio; LVEF = left ventricular ejection fraction. a Mitral or tricuspid valve replacement; previous thromboembolism; atrial fibrillation; mitral stenosis of any degree; LVEF <35% . b Carbomedics, Medtronic Hall, ATS, Medtronic Open-Pivot, St Jude Medical, Sorin Bicarbon. c Other bileaflet valves with insufficient data. d Lillehei-Kaster, Omniscience, Starr-Edwards (ball-cage), Bjorik-Shiley and other tilting-disc valves. FIND OUT MORE ON GUIDELINES OPERATE WITH THE FACTS ABBOTT MECHANICAL HEART VALVES SHOW LOWER THROMBOEMBOLISM, THROMBOSIS AND BLEEDING EVEN AT A LOW INR RANGE INR 1.5 2.0 2.5 LOWERING-IT2 (target INR 1.5–2.5) Randomized Study 197 patients implanted* (44 with Abbott valves, 153 with LivaNova valves), 5 years Thromboembolism 0.09%/pt-year Thrombosis 0%/pt-year Bleeding Events 0.56%/pt-year ESCAT III3 (target INR 1.6–2.1) Randomized Study Thromboembolism Bleeding Events 1137 patients** (all Abbott valves), 2 years 0%/pt-year, 0.58%/pt-year*** 0.58%/pt-year, 1.07%/pt-year† PROACT4 (target INR 1.5–2.0) Randomized Study Thromboembolism Bleeding Events 375 patients (all On-X Valves), 3 years 2.67%/pt-year 2.67%/pt-year *44/197 patients in the Lowering-IT study were implanted with Abbott Valves. **This was further stratiﬁed into a control group, a very low INR (monitored 1x weekly), and a very low INR (monitored 2x weekly) group. ***Thromboembolic events for VL1 and VL2 groups are listed together, respectively.†Bleeding events for VL1 and VL2 groups are listed together, respectively. CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Information contained herein for Europe, Middle East and Africa ONLY. Check the regulatory status of the device in areas where CE marking is not the regulation in forc

FAQs

What is the Pivot Guard Design and what benefits does it provide?

The Pivot Guard Design offers benefits during implantation and after implantation. It shields the pivot mechanism from pannus ingrowth, minimizes interaction with sub-annular native valve apparatus in the mitral position, and helps ensure coronary ostia clearance in the aortic position.

How does the brochure describe outcomes related to low INR ranges?

It reports lower thromboembolism, thrombosis, and bleeding even at low INR ranges, referencing studies such as Lowering-IT, ESCAT III, and PROACT with target INR intervals and event rates.

Which mechanical valve models are included for aortic and mitral positions?

The brochure highlights Regent, Masters HP, and Masters mechanical heart valves and discusses their applicability in the aortic and mitral positions. It also notes options intended for very small patients.

Oct 28, 2026

Upload by dawugda