- Five topical presentations at TCT 2022 highlight the impact of Abbott’s structural heart devices for repairing or replacing heart valves and closing holes in the heart
- New data confirm the safety and effectiveness of MitraClip™ for the treatment of mitral regurgitation
- Results also demonstrate the benefits of Abbott’s TriClip™ for tricuspid regurgitation, Amulet™ for stroke reduction in patients with atrial fibrillation, and Portico™ for aortic stenosis
ABBOTT PARKI will., September 17, 2022 /PRNewswire/ — Abbott (NYSE: ABT) today announced data from five topical presentations demonstrating the benefits of its minimally invasive devices in the treatment of people with a range of structural heart diseases. The data include findings that reinforce the value of MitraClip™, the world’s first and leading transcatheter end-to-end repair (TEER) device, for the treatment of ruptured valves in people with mitral regurgitation (MR).
New data surrounding Abbott’s structural heart therapies were presented on 34th Annual Scientific Symposium on Transcatheter Cardiovascular Therapy (TCT) of the Cardiovascular Research Foundation in Boston (September 16-19, 2022). Results were also presented on TriClip™, the first therapy designed specifically for tricuspid heart valve repair; Amplatzer™ Amulet™ Left Atrial Appendage Occluder, a minimally invasive option offering the most complete occlusion of the left atrial appendage (LAA) to reduce the risk of stroke; and Portico™, a self-expanding transcatheter aortic valve implantation (TAVI) system.
Structural heart disease such as valve disease or holes in the heart that require closing can disrupt the way the heart moves blood through the body. New minimally invasive technology has changed the way doctors approach patient care and limits the need for more complex or risky surgeries.
MitraClip EXPAND G4 Post-Approval Study
Data presented from the real-world, prospective, multicenter, global EXPAND G4 study support the safety and effectiveness of the MitraClip G4 System for the treatment of MR. The study represents the largest report of 30-day core laboratory results involving more than 1,000 patients. Data confirm that MitraClip offers a high success rate in terms of MR reduction, improvements in quality of life and low rates of adverse events.
Key 30-day findings include:
- A significant reduction in MR to mild or less (≤ grade 1+ on a four-point scale) was achieved in 91% of patients, with the lowest reported adverse event rates to date (1.3% 30-day all-cause mortality )
- Clinical improvements, including 83% of patients achieving New York Heart Association (NYHA) functional class I/II (a classification of functional limitations resulting from heart disease, with class I/II denoting mild or no limitation of physical activity), improvement from 52% of the baseline of 31%; and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (self-rated social abilities, symptoms, and quality of life), a 35% improvement from baseline
- Multiple clip sizes allow therapy to be tailored to the patient’s mitral valve anatomy and broaden the spectrum of patients suitable for TEER
“MitraClip therapy has fundamentally changed the way physicians treat mitral regurgitation, provides a valuable therapeutic option that does not require open heart surgery and goes beyond simple symptom management with medication,” said Jason RogersMD, Professor of Cardiovascular Medicine and Director of Interventional Cardiology and Structural Heart Training Programs at University of California, Davis Medical Center. “These latest data demonstrate and strengthen the evidence that Abbott’s MitraClip system consistently reduces MR in a wide range of patients while restoring proper mitral valve function and improving patients’ quality of life.”
The MitraClip System has been commercially available in the US since 2013 and in Europe since 2008. With more than 150,000 patients treated worldwide, MitraClip is approved in more than 75 countries covering regions in Asia, Africa, EuropeNorth and South America and Australia.
“These results add to what has been proven through nearly two decades of clinical experience in transcatheter mitral repair—the MitraClip provides long-term, significant reductions in mitral regurgitation that change and save lives,” said Michael Dale, senior vice president of Abbott’s structural cardiac business. . “Abbott was the first to offer a transcatheter mitral valve repair device that provides a minimally invasive treatment option for MR patients who would otherwise go untreated, and we remain committed to addressing the unmet needs of people with structural heart disease.”
First results of the TriClip TRILUMINATE pivotal trial
TRILUMINATE Pivotal is the first randomized, controlled clinical trial evaluating the safety and effectiveness of TEER with TriClip in 700 patients with severe TR in the US, Canada and Europe. Data from the entered cohort at 30 days show:
- High implantation success rate (99%)
- At least one grade reduction in TR in 91% of patients, with moderate or less residual TR achieved in 74%
- Patients who achieved an improvement of about 17 points in the KCCQ score, a 30% improvement from baseline, demonstrating a significant improvement in their quality of life
Three-year results of the Amulet IDE study
The Amplatzer Amulet LAA Occluder with double-seal technology (consisting of a lobe or part to fill the LAA cavity and a disk to close the hole in the LAA) is the first and only minimally invasive treatment option that offers immediate and complete double-seal closure of LAA, which reduces the risk of stroke and eliminates the need for blood-thinning drugs. The prospective, international, multicenter Amulet IDE trial is the largest randomized LAA occlusion study to date, consisting of more than 1,800 patients, and three-year results demonstrate the safety and effectiveness of Amulet, with data showing:
- Device-related factors (device-related thrombosis or leakage around the device) more often preceded strokes in patients with Boston Scientific’s Watchman‡ than those with Amulet
- Both cardiovascular and all-cause mortality tended to be higher with the Watchman device than with the Amulet device
PREDICT-LAA Sample (Amulet)
Data were also presented from the prospective, multicenter, randomized controlled trial PREDICT-LAA, which investigated whether the use of computational models based on cardiac computed tomography (a high-resolution scan of patients’ hearts generated by FEops HEARTguide‡) helps in planning the Amplatzer Amulet procedures. Key findings after three months include:
- Improved procedural efficiency and safety outcomes with the Amplatzer Amulet LAA Occluder were achieved when planned with HEARTguide
Portico CONFIDENCE Register
The CONFIDENCE registry is an international prospective real-world study evaluating the safety and effectiveness of the Portico TAVI valve using the first-generation Portico delivery system in 501 patients and the second-generation FlexNav™ delivery system in 500 patients. The latest data on valve hemodynamics (blood flow) at 30 days and one-year survival after implantation of the Portico TAVI device will be presented at TCT on Sunday, September 18
For US-important MitraClip safety information, visit http://abbo.tt/MitraClipG4ISI.
For US-important Amulet safety information, visit https://abbo.tt/AmuletISI.
For US-important Portico safety information, visit https://abbo.tt/PorticoISI.
The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device in the US only
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