New Late-Breaking Data Highlight Abbott Structural Heart Transcatheter Valve Therapies

  • Data presented at EuroPCR 2022 reinforce the impact of Abbott's minimally invasive heart devices on patient outcomes and quality of life
  • Findings demonstrate TriClip™ transcatheter edge-to-edge (TEER) repair is effective at reducing tricuspid regurgitation across a broad range of anatomies
  • One-year outcomes for Navitor™ transcatheter aortic valve implantation (TAVI) system show the safety and effectiveness of this therapy and durable performance of the sealing cuff in minimizing paravalvular leak for patients with severe aortic stenosis

Abbott (NYSE: ABT) today announced two late-breaking data presentations highlighting both TriClip™, a first-of-its kind minimally invasive tricuspid heart valve repair device, and Navitor™, the company's latest-generation transcatheter aortic valve implantation (TAVI) system. The company also showcased new data for MitraClip™ and Amplatzer™ Amulet™, two key components of the company's industry-leading structural heart portfolio.

All data were presented at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, held in Paris from May 17-20, 2022 .

30-Day Results from the TriClip bRIGHT Study

New real-world outcomes highlighted in a late-breaking data presentation showed that the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems significantly reduce tricuspid regurgitation (TR) and substantially improve quality of life across a wide range of anatomically diverse patients, with data through 30 days showing:

  • High implant success rate (98%)
  • Significant TR reduction (71% moderate or less compared to 3% as baseline) with a strong safety profile (99% freedom from major adverse events)
  • Life-changing clinical improvements including 78% of patients achieving New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease), an improvement by 57% from baseline of 21%, and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life)

"Historically, people suffering from severe tricuspid regurgitation had extremely limited treatment options despite being very ill. Many were ineligible for surgery and were limited to symptom management," said Philipp Lurz , M.D., Ph.D., professor and deputy head of cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany . "The late-breaking data show a high rate of implant success and significant reduction in regurgitation. Transcatheter edge-to-edge repair using TriClip has a huge potential to improve patients' quality of life and has entered the clinical stage with widespread use in Europe ."

One-Year Results from Study on the Next-Generation Navitor TAVI System

Data from the multi-center, international, single arm study of the Navitor TAVI system with an active sealing cuff to minimize paravalvular leak (PVL) demonstrated improved one-year outcomes for patients with severe, symptomatic aortic stenosis who were at high or extreme surgical risk. Key findings include:

  • High procedural success rate of 97.5%
  • High rate of no/trace PVL (70.2%) and low rate of mild PVL (28.8%) through one year, indicating the active sealing cuff is effective in mitigating PVL
  • Low rate of all-cause mortality (4.2%) at one year
  • Single-digit gradients (average 7.5 mmHg) through one year

"Patients with symptomatic, severe aortic stenosis are often at high risk of complications from open-heart surgery due to their old age, frailty or having multiple other diseases and conditions," said Dave Smith , M.D, professor and consultant cardiologist, Morriston Hospital, Swansea, Wales . "The one-year results from the study demonstrate that a minimally invasive TAVI procedure with a Navitor valve offers a safe and effective treatment option for these patients."

Other data sets presented at EuroPCR included positive findings from the EXPAND study which showed MitraClip therapy in heart failure patients with mitral regurgitation experience improved symptoms and quality of life. Additionally, although women have higher rates of early complications with LAA closure than men, results from the Amulet IDE trial found that both women and men implanted with Abbott's Amplatzer Amulet Left Atrial Appendage (LAA) Occluder experienced similar long-term benefits from LAA closure.

"At Abbott, we're dedicated to delivering innovative technologies to help people with debilitating heart conditions live better lives through better health," said Michael Dale , senior vice president of Abbott's structural heart business. "The data presented during this year's EuroPCR meeting underscore our unwavering commitment to providing structural heart solutions, supported by clinical evidence, that surpass existing standards of care."

The TriClip Transcatheter Tricuspid Valve Repair System and Navitor Transcatheter Aortic Valve are approved for investigational use only in the U.S.

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

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

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 .

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SOURCE Abbott

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

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

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  • 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
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Medtronic announces FDA approval of minimally invasive device to treat hypertension

The Symplicity blood pressure procedure offers patients a new adjunct approach to lowering blood pressure

Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral ™ renal denervation (RDN) system, also known as the Symplicity ™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.

Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low. These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.

"Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension."

The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.

"The Symplicity blood pressure procedure is safe and effective, providing significant 'always on' blood pressure reductions for patients," said David Kandzari , M.D., chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study."

Patient preference and shared decision making have been identified as critical components of developing a hypertension care plan including the Symplicity blood pressure procedure. According to results from a Medtronic-led patient preference study, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one third of patients were likely to choose the interventional treatment.

"This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes," said Raymond Townsend , M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program. "The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down."

The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN and is backed by experience in more than 25,000 patients treated globally, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk. Although currently limited for investigational use in Japan , China and Canada , the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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 (NYSE:MDT), visit www.Medtronic.com , and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:



Krystin Hayward Leong


Ryan Weispfenning

Public Relations


Investor Relations

+1-508-261-6512


+1-763-505-4626

(PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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Medtronic More than half (51%) of U.S. adults are optimistic new applications of artificial intelligence (AI) will lead to major advancements and breakthroughs in healthcare in the year ahead, according to a new survey from Medtronic, a global healthcare technology leader, and Morning Consult

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