Late-Breaking Data Show Breadth of Abbott's Minimally Invasive Structural Heart Technologies

Five late-breaking presentations at TCT 2022 highlight the impact of Abbott's structural heart devices to repair or replace heart valves and close openings in the heart
New data reinforce the safety and effectiveness of MitraClip™ for treating 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 (NYSE: ABT) today announced data from five late-breaking presentations showing the benefits of its minimally invasive devices in treating people with a range of structural heart diseases. Data include findings that reinforce the value of MitraClip™, the world's first and leading transcatheter edge-to-edge repair (TEER) device, to treat leaky valves in people with mitral regurgitation (MR).

The new data around Abbott's structural heart therapies were presented at the 34 ^th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium 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; the Amplatzer™ Amulet™ Left Atrial Appendage Occluder, a minimally invasive option offering the most complete closure of the left atrial appendage (LAA) to reduce risk of stroke; and Portico™, a self-expanding transcatheter aortic valve implantation (TAVI) system.

Structural heart diseases such as valve disease or openings in the heart that require closure can impair how the heart moves blood through the body. New minimally invasive technology has changed how physicians approach patient care and limits the need for more complex or risky surgery.

MitraClip EXPAND G4 Post-Approval Study
Data presented from the prospective, multi-center, global real-world EXPAND G4 study support the safety and effectiveness of the MitraClip G4 system for treating MR. The study represents the largest report of 30-day core lab-assessed outcomes, which included more than 1,000 patients. The data confirm that MitraClip offers high success rates in terms of MR reduction, improvements in quality of life and low adverse event rates.

Key findings through 30 days include:

Significant MR reduction to mild or less (≤ grade 1+ on a four-point scale) is achieved in 91% of patients, with lowest reported adverse event rates to date (1.3% all-cause mortality at 30 days)
Clinical improvements including 83% of patients achieving New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease, with Class I/II meaning slight or no limitation of physical activity), an improvement of 52% from baseline of 31%; and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life), a 35% improvement from baseline score
Multiple clip sizes enable tailoring the therapy to patients' mitral valve anatomy and expand the spectrum of TEER-suitable patients

"MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation, provides a valuable therapy option that does not require open-heart surgery, and goes beyond simply managing symptoms with medications," said Jason Rogers , M.D., professor of cardiovascular medicine and director of interventional cardiology and structural heart training programs at the University of California, Davis Medical Center. "These late-breaking data demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces MR in a broad range of patients, while restoring proper function of the mitral valve and improving patients' quality of life."

The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 150,000 patients treated worldwide, MitraClip is approved in more than 75 countries, spanning regions in Asia , Africa , Europe , the Americas and Australia .

"These results add to what's been proven through nearly two decades of clinical experience in transcatheter mitral repair – MitraClip provides long-term, significant mitral regurgitation reduction that changes and saves lives," said Michael Dale, senior vice president of Abbott's structural heart business. "Abbott was the first to offer a transcatheter mitral valve repair device that provides a minimally invasive treatment option for patients with MR who would otherwise go untreated, and we remain committed to addressing the unmet needs of people with structural heart conditions."

First Results from 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 U.S., Canada and Europe . The data from the roll-in cohort through 30 days show:

High implant success rate (99%)
At least a one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74%
Patients achieving around a 17-point improvement in the KCCQ score, a 30% improvement from baseline score, which demonstrates a substantial improvement in their quality of life

Three-Year Outcomes from the Amulet IDE Study
The Amplatzer Amulet LAA Occluder with dual-seal technology (consisting of a lobe or piece to fill the cavity of the LAA and a disc to close off the opening into the LAA) is the first and only minimally invasive treatment option to offer immediate and complete dual-sealing closure of the LAA, reducing the risk of stroke and eliminating the need for blood-thinning medication. The prospective, international, multi-center Amulet IDE trial is the largest randomized LAA occlusion study to date consisting of more than 1,800 patients, and three-year outcomes demonstrate the safety and effectiveness of Amulet, with data showing:

Device-related factors (device-related thrombosis or peri-device leak) more frequently preceded strokes in patients with Boston Scientific's Watchman‡ than those with Amulet
Both cardiovascular and all-cause death trended higher in the Watchman device than the Amulet device

PREDICT-LAA Trial (Amulet)
Data were also presented from the PREDICT-LAA prospective, multi-center, randomized controlled trial that studied if the use of cardiac computed tomography-based computational models (high-resolution scans of patients' hearts generated by FEops HEARTguide‡) help in the planning of Amplatzer Amulet procedures. Key findings at three months include:

Improved procedural efficiency and safety outcomes with the Amplatzer Amulet LAA Occluder were achieved when planned with HEARTguide

Portico CONFIDENCE Registry
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. Late-breaking data on valve hemodynamics (blood flow) at 30 days and one-year survival following implantation of the Portico TAVI device will be presented at TCT on Sunday, Sept. 18

For U.S. important safety information on MitraClip, visit https://abbo.tt/MitraClipG4ISI .

For U.S. important safety information on Amulet, visit https://abbo.tt/AmuletISI .

For U.S. important safety information on Portico, visit https://abbo.tt/PorticoISI .

The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device only in the U.S.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.

View original content: https://www.prnewswire.com/news-releases/late-breaking-data-show-breadth-of-abbotts-minimally-invasive-structural-heart-technologies-301626621.html

SOURCE Abbott

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Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
The new programs build on a successful first year of the multi-million-dollar corporate initiative

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Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR₁₂) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR₁₂was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.¹ In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD².
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.³
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR₄
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR₁₂) are considered cured of
hepatitis C
About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR₁₂.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
¹ Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
² IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
³ American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

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About Medtronic
Bold thinking. Bolder actions. We are Medtronic . Medtronic plc , headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic , visit www.Medtronic.com and follow Medtronic on LinkedIn .

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Late-Breaking Data Show Breadth of Abbott's Minimally Invasive Structural Heart Technologies

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