Coronary/Structural Heart

HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

Coronary/Structural Heart Financial by Comments are Disabled

MOUNTAIN VIEW, Calif., June 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product. Five Medicare Administrative Contractors (MACs), CGS, NGS, Noridian, Palmetto GBA, and WPS, released draft Local Coverage Determinations (LCD) for Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA). These draft LCDs recognize the importance of quantifying coronary artery plaque, which underscores the pivotal role HeartFlow technology plays in diagnosing and managing treatment for patients in need of cardiovascular care. HeartFlow’s accurate and actionable Plaque Analysis aligns with the Centers for Medicare & Medicaid Services (CMS) commitment to supporting technologies that enhance diagnostic accuracy and patient care: HeartFlow Plaque Analysis is the only FDA cleared plaque analysis with a reported 95% agreement prospectively compared to the gold standard, IVUS.¹Two out of three patients had their medical management changed and more precisely tailored with HeartFlow Plaque Analysis.² Plaque Analysis is a major function of the HeartFlow portfolio, which offers the only comprehensive, AI-driven, precision coronary care solution based on the guideline-directed cardiac CT pathway, backed by robust clinical evidence and guidelines. HeartFlow FFRCT has an established reimbursement pathway which is covered for 99% of people in the US with health insurance. Leveraging our expertise and proven success creating new AI reimbursement categories as done with HeartFlow FFRCT, similar coverage and adoption for Plaque Analysis is anticipated, ensuring it becomes an integral part of coronary care. “We are excited about this milestone, as it highlights the critical importance of accurately quantifying plaque in cardiovascular disease management,” said John Farquhar, chief executive officer at HeartFlow. “This recognition by the MACs in the draft policies is a testament to the clinical value of Plaque Analysis and its potential to revolutionize how cardiovascular disease is diagnosed and treated, for all.” The release of these draft LCDs mark the first step in integrating accurate plaque measurement into standard clinical practice. Next steps toward coverage include a period for input from clinicians and other stakeholders before policy is finalized and released. “We are confident that Plaque Analysis will not only meet but exceed the rigorous standards of Medicare,” added Cara Santillo, Senior Vice President of Market Access and Reimbursement at HeartFlow. “This nod of support from the MACs underscores the importance of access and equity in cardiovascular care by ensuring that all patients, regardless of background, receive the critical insights needed for treatment for cardiovascular disease.” About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media Contact Linly Ku Digital Marketing Manager media@heartflow.com Investor Contact Nick Laudico VP of Business Development and Investor Relations nlaudico@heartflow.com 1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024. ² Rinehart et al. JSCAI 2024. https://doi.org/10.1016/j.jscai.2024.101296

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Cadrenal Therapeutics Highlights Presentation of New Trial Data at ISHLT Conference Demonstrating the Importance of Anticoagulation Quality in LVAD Patients

Coronary/Structural Heart by Comments are Disabled

Tecarfarin, which recently received Orphan Drug Designation from the FDA for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, has the potential to improve the time in therapeutic range a factor correlated in the ARIES-HM3 trial with better patient outcomes
PONTE VEDRA, Fla., June 3, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, today highlighted a groundbreaking presentation at the International Society for Heart & Lung Transplantation (ISHLT) 44th Annual Meeting & Scientific Sessions.
These new findings from secondary analyses of the ARIES-HM3 trial were released in a presentation titled, “Impact of Vitamin K Antagonist (VKA) Therapy On Outcomes In a Randomized Controlled Trial of Aspirin Removal In Left Ventricular Assist Device (LVAD) Patients – A Pre-Specified Analysis From the Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure, or the ARIES-HM3, Randomized Clinical Trial.”
The ARIES-HM3 trial data demonstrated that lower time in therapeutic range, or TTR, translated directly to excessive bleeding events. The “average” patient in the ARIES-HM3 study had a 30% rate of serious bleeding events even after aspirin was eliminated as part of the antithrombotic regimen, and persistent bleeding was inversely correlated with TTR.
The ARIES-HM3 clinical study was sponsored by Abbott (NYSE: ABT), which evaluated a new clinical approach to patient management that included removal of aspirin as part of the antithrombotic regimen warfarin. The data is currently under review by the FDA. Labeling changes related to the antithrombotic regimen have not been approved by the FDA at this time.
Dr. Mandeep Mehra, who chaired the ARIES-HM3 study, holds the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and is Executive Director of the Center for Advanced Heart Disease at Brigham and Women’s Hospital, commented, “This comprehensive analysis identifies adequacy of VKA use (as measured by TTR) as a significant risk marker for bleeding events and provides new clinical direction for further mitigation of bleeding to enhance hemocompatibility with the HeartMate 3 LVAD.” Mehra continued, “Each incremental improvement of 10% above the median of 56% TTR trends in a significant further reduction in bleeding rate. Tecarfarin could potentially be an important therapy for patients with LVADs who all require chronic anti-coagulation since it does not get affected by drug-drug interactions or changes in kidney function like warfarin and deserves further study.”
“The ARIES-HM3 trial data underscores the deficiencies of warfarin and the need for a new VKA therapy for patients with LVADs. We believe our drug candidate, the next-generation VKA tecarfarin, with its unique retrometabolic design that provides for more stable anticoagulation than warfarin, is the much-needed replacement therapy. We intend to pursue a pivotal trial evaluating tecarfarin effectiveness for LVAD patients,” said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Cadrenal commends Abbott’s commitment to LVAD patients in sponsoring this important trial and analyses.”
On April 9, 2024, Cardenal Therapeutics announced that the United States Food and Drug Administration (FDA) had granted tecarfarin Orphan Drug Designation for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device, which includes the left ventricular assist device (LVAD).
The current market-leading direct oral anticoagulants (DOACs), such as Eliquis, are not indicated for patients with LVADs due to a lack of evidence of benefit, while the level of anticoagulation achieved with warfarin was achieved in the target range only 56% of the time in the ARIES-HM3 trial. Patients whose level of anticoagulation was in the therapeutic range > 56% had better outcomes than those with lower levels. This highlights the potential role for investigating new VKA agents in improving clinical outcomes in LVAD patients.
VKA anticoagulation is prescribed for the prevention of LVAD-related clotting. However, the only available VKA is warfarin, which was approved for human use in 1954. Tecarfarin has been shown to improve TTR, particularly in patients taking multiple medications, and be more stable in patients with renal dysfunction which is common in LVAD patients.
ABOUT CADRENAL THERAPEUTICS, INC.Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib) and just received orphan drug designation for the prevention of thrombosis and thromboembolism in patients with ventricular assist devices (VADs). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with thrombotic antiphospholipid syndrome (APS). Tecarfarin is a next-generation Vitamin K Antagonist (VKA) specifically designed to use a different metabolism pathway than the oldest and most commonly prescribed VKA warfarin. Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.  
Safe Harbor StatementAny statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding tecarfarin having the potential to improve the time in therapeutic range which analysis of the ARIES-HM3 trial reveals is associated with better patient outcomes. TTRs as predicting increased risk for bleeding events, the VKA tecarfarin, filling the market void for a next-generation VKA, the Company pursuing a pivotal trial evaluating tecarfarin effectiveness for LVAD patients. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve the time in therapeutic range, the ability of the Company  to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:Matthew Szot, CFO858-337-0766[email protected] 
Investors:Lytham Partners, LLCRobert Blum, Managing Partner602-889-9700[email protected] 
SOURCE Cadrenal Therapeutics, Inc.

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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

Coronary/Structural Heart by Comments are Disabled

HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation Paris, June 3rd 2024 – HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a US Pivotal Study with its technology. The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment. This patient population lacks approved therapeutic options, leading to a poor prognosis with many recurrent hospitalizations and reduced life expectancy. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC. Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC. Study results have been presented at conferences globally and published in JACC (Journal of the American College of Cardiology) – Cardiovascular Interventions1. Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai (New York, USA) will be the Principal Investigator of the Pivotal study. “I am honored to lead the HighLife pivotal study. There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option. The HighLife TMVR solution offers the potential to provide important clinical benefits for these high-risk patients. We are gratified that FDA has granted approval for this pivotal study that will further advance the management of patients with MR” commented Prof. Stone. Georg Börtlein, Founder and Chief Executive Officer of HighLife, said, “We are extremely pleased with the FDA IDE approval for our US pivotal study, marking a significant milestone in our US clinical strategy. This approval aligns with the maturity of our extensive clinical dataset generated over multiple sites across three continents. We are also making great progress towards CE mark readiness, eagerly anticipating the market introduction of our technology in Europe.” The HighLife technology will be featured at NY Valves annual meeting on Thursday, June 6th   at 11am in the session “Innovation at NYV: Transfemoral TMVR – Technology and Clinical Updates” – Room: Innovation & FDA, 504, Level 5, Jacob K. Javits Convention Center, North. About HighLife HighLife SAS, headquartered in Paris, France, with facilities in Irvine, California, is a pre-commercial stage company. It is focused on the development of a novel transcatheter replacement system for treating mitral regurgitation. The TSMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The technology is implanted in a simple, 3-step procedure. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents. For more information, visit https://www.highlifemedical.com/ Caution: The HighLife Valves are investigational devices and not for sale in any geography. About Mitral Regurgitation Mitral Regurgitation is a growing public health concern, affecting over 2% of the total population2. It refers to a condition in which the valve between the heart’s left chambers (the mitral valve) does not close completely, allowing blood to leak back across it, rather than continuing to supply the organs with oxygenated blood. Without proper treatment, severe Mitral Regurgitation can cause major heart problems or even lead to heart failure. Limited treatment options are available for many patients at high surgical risk, TSMVR solutions offer a less invasive alternative to traditional open-heart surgery. Contact: HighLife MedicalAmina Benkabouabenkabou@highlifemed.comTel : +33 (0)1 72 32 21 25 1 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study. J Am Coll Cardiol Intv. 2023 Dec, 16 (23) 2854–28652Burden of valvular heart diseases: a population base study. Nkomo VT et al.
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030624_HighLife_PR FDA Pivotal Trial_

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Half Moon Medical Announces 15 Patients Treated in Pilot Study with Transcatheter Mitral Valve Repair System

Coronary/Structural Heart by Comments are Disabled

Clinical progress to be highlighted in key presentations at New York Valves
MENLO PARK, Calif., May 31, 2024 /PRNewswire/ — Half Moon Medical today announced the treatment of 15 patients with its second generation Half Moon transcatheter mitral valve repair technology (TMVr) as part of an ongoing pilot study. Half Moon Medical also announced two upcoming presentations by leading physicians at the New York Valves conference in June 2024.
The investigational Half Moon mitral valve repair device is designed to restore mitral valve function in patients with severe symptomatic mitral regurgitation (MR), a disease where blood leaks backwards within the heart due to the mitral valve’s inability to close properly. The device is deployed using a percutaneous (from the leg) delivery catheter, which is navigated through the vasculature to the diseased native mitral valve. The Half Moon device has been shown to produce significant, sustained reduction in MR without an increase in pressure gradient across the valve in a wide range of valve anatomies not addressable by other percutaneous therapies.
Leading interventional cardiologists in the US and Australia have implanted the Half Moon device in the ongoing pilot study. “The Half Moon device allowed us to successfully treat a patient with severe mitral regurgitation who had no other meaningful treatment options. We are very excited about the opportunity to expand our percutaneous toolbox for the treatment of mitral valve disease” said Dr. Stan Chetcuti, Director of the Cardiac Catheterization Laboratory at University of Michigan, who treated the 15th patient with the Gen 2 Half Moon device along with his team consisting of Dr. Neal Duggal, Director of Anesthesia for Structural Heart Interventions, and Dr. Matthew Romano, Associate Professor of Cardiac Surgery.
Two physician-led presentations highlighting the Half Moon device will be featured at the New York Valves Conference in New York City, June 5-7th, 2024. Dr. Azeem Latib, System Director of Interventional Cardiology at Montefiore Health System in Bronx, NY, will be presenting interim data from the Half Moon pilot study on Wednesday June 5th, 2024. On Thursday June 6th, 2024, Dr. Hemal Gada, President of UPMC Heart and Vascular Institute in Harrisburg PA, will present a case he performed with the Half Moon device in a patient with complex mitral valve pathology that could not be addressed by transcatheter edge to edge mitral valve repair or transcatheter mitral valve replacement.
“We are encouraged by the promising results we have seen to-date with the Gen 2 Half Moon device significantly reducing mitral regurgitation in a wide range of challenging anatomies” said Matt McLean, CEO and Co-Founder of Half Moon Medical. “We are also thankful to our physician partners who are bringing this innovative therapy to patients in need.”
About Half Moon Medical
Half Moon Medical (Menlo Park, CA) is privately held company that was founded in 2017 at The Foundry LLC (Menlo Park, CA), a leading medical device incubator that rapidly transforms concepts into companies. Half Moon Medical is developing a minimally invasive technology to treat mitral regurgitation, a disease affecting an estimated four million people. Half Moon Medical is enrolling patients in a pilot study in the US, Canada and Australia.
Contact: Matt McLean, [email protected] 
SOURCE Half Moon Medical

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Data from the PRECISION study of aprocitentan to be presented at the European Society of Hypertension Annual Meeting 2024

Coronary/Structural Heart by Comments are Disabled

Allschwil, Switzerland – May 31, 2024 Idorsia Ltd (SIX: IDIA) today announced that data from the Phase 3 study of aprocitentan, Idorsia’s endothelin receptor antagonist, will be presented by Prof. Krzysztof Narkiewicz, MD, PhD, at the European Society of Hypertension’s 33rd European Meeting of Hypertension and Cardiovascular Protection, taking place in Berlin, Germany, May 31 – June 3, 2024. An oral presentation is scheduled for Sunday, June 2 (09:05 – 09:15 CEST) in Convention Hall I C, as part of the “Clinical Studies” session, entitled “Blood pressure control with aprocitentan in resistant hypertension”. The presentation focuses on a pre-planned analysis evaluating the efficacy of aprocitentan on the percentage of patients with controlled blood pressure according to hypertension guidelines at different timepoints during the Phase 3 PRECISION study. The abstract can be found here. A poster presentation is scheduled for Saturday, June 1 (18:50 – 18:55 CEST) as part of the session “Moderated E-poster session 7 – Clinical studies”, entitled “Effect of high dose aprocitentan in patients with resistant hypertension not controlled by low dose”. The presentation focuses on a post-hoc exploratory analysis evaluating the observed long-term benefit of increasing to a higher dose of aprocitentan (25 mg) in patients not achieving a blood pressure control after 4 weeks on the lower dose (12.5 mg). The abstract can be found here. Notes to the editor About aprocitentanAprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. In May 2022, Idorsia announced positive top-line results of the Phase 3 PRECISION study with aprocitentan for the treatment of patients with resistant hypertension. Detailed results were published in The Lancet and presented as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions in November 2022. More details and commentary can be found in the dedicated press release and an investor webcast featuring Prof. Markus Schlaich, an investigator in PRECISION. On March 19, 2024, aprocitentan was approved as TRYVIO in the US, with availability planned for H2 2024. On April 25, 2024, Idorsia received a positive opinion for aprocitentan (as JERAYGO™) from the Committee for Medicinal Products for Human Use (CHMP) as a treatment of resistant hypertension. A CHMP positive opinion is one of the final steps before marketing authorization can be granted by the European Commission; a final decision is expected approximately two months after publication of the CHMP opinion. About Prof. Krzysztof Narkiewicz, MD, PhDProfessor Krzysztof Narkiewicz is the Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland. His research has been focused on the role of the sympathetic nervous system and metabolic factors in regulation of cardiovascular function in physiological and pathological states, and on prevention and treatment of cardiometabolic diseases including hypertension, diabetes, coronary artery disease, congestive heart failure and obstructive sleep apnea. He has published over 700 full-text publication; ( > 39 000 citations; h-index: 69). He was the President of the Scientific Council of the European Society of Hypertension (2009-2011). He was a member of the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) preparing the 2007, 2013 and 2018 Guidelines for the Management of Arterial Hypertension. He also contributed to the 2023 ESH hypertension guidelines. Prof. Krzysztof Narkiewicz serves as a consultant to Idorsia. About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.commedia.relations@idorsia.com www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
Anhang

Medienmitteilung PDF

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InnovHeart Announces First-In-Human Trans-Septal Implantation of Saturn Mitral Valve Replacement

Coronary/Structural Heart by Comments are Disabled

NEWTON, Mass. and MILAN, May 30, 2024 /PRNewswire/ — InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral regurgitation (MR), announced today the first trans-septal clinical trial implant with the proprietary Saturn Transcatheter Mitral Valve. Excellent hemodynamic results are reported for the patient, a 79 year old female suffering from severe mixed (degenerative and functional) mitral regurgitation. The Trans-Septal TMVR procedure was performed as part of the on-going European clinical trial, the CASSINI-EU study, on May 8th, 2024 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD1; Giedrius Davidavičius, MD1; Agnė Drąsutienė, MD1; Vilhelmas Bajoras, MD1; supported by Torsten Vahl, MD2; Lauren Ranard, MD2; Paolo Denti, MD3; and Stefano Stella, MD3.
“We were honored to work with this outstanding international team providing life-changing novel TMVR therapy for this high surgical-risk patient. It is particularly rewarding to support the InnovHeart progression from trans-apical to trans-septal delivery of the Saturn Valve at our Institute,” said Dr. Giedrius Davidavičius. “This first case is a critical step to validate that the Saturn valve can be successfully delivered via a fully percutaneous, transfemoral transseptal approach. The Saturn prosthesis has a unique modular design comprising an annular ring and low-profile valve that can reverse remodel the native annulus, avoid LVOT obstruction and eliminate MR” said Dr. Torsten Vahl.  
“Overall, this important case demonstrates that the Saturn valve can be successfully implanted with either retrograde or antegrade approaches. It is exciting to add trans-septal delivery and begin to expand the clinical experience for the Saturn valve beyond the initial trans-apical study, now in long-term follow-up. I continue to believe that Saturn will become a valuable new therapy with fewer anatomical exclusions than other technologies, with the potential to treat a wider range of patients,” said Dr. Paolo Denti who is the Principal Investigator for the CASSINI-EU study. “We are very grateful for the skilled physicians who successfully completed our first trans-septal CASSINI study case and for our Founder and CTO, Giovanni Righini, for realizing this very important milestone for patients and the company,” said David Wilson, InnovHeart CEO. The CASSINI-EU study will expand to multiple countries and enroll up to 30 patients with moderate to severe or severe MR.
1 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania2 Structural Heart and Valve Center, New York-Presbyterian Hospital, Columbia University Irving Medical Center, New York, USA 3 San Raffaele University Hospital, Milano, Italy
About InnovHeart
InnovHeart is a medical device company dedicated to providing new treatment options for people suffering from moderate to severe or severe mitral regurgitation (MR) and who need a mitral valve replacement. The InnovHeart proprietary Saturn Transcatheter Mitral Valve Replacement (TMVR) System is designed to eliminate mitral regurgitation and restore normal valve function. InnovHeart is a privately held company located in Colleretto Giacosa, Italy and Newton, Mass, USA. For more information, please visit www.InnovHeart.com and follow us on LinkedIn and X (@InnovHeart).
Caution: The SATURN Transcatheter Mitral Valve Replacement (TMVR) System is limited to investigational use and is not commercially available in any country.

SOURCE InnovHeart

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The Lancet Publishes Results from World’s Largest Coronary CT Registry Showing New AI Technology Can Predict Cardiac Events Due to Coronary Inflammation At Least 10 Years in Advance

Coronary/Structural Heart by Comments are Disabled

OXFORD, England, May 30, 2024 /PRNewswire/ — Caristo Diagnostics Limited, a global leader in cardiovascular disease diagnostics and risk prediction, announced the results of a landmark clinical study published in The Lancet that support the ability of Caristo’s CaRi-Heart® AI technology to quantify coronary artery inflammation and accurately predict cardiac events.
This landmark study, titled “Inflammatory risk and cardiovascular events in patients without obstructive coronary artery disease: the ORFAN multicentre, longitudinal cohort study,” analysed results from the first 40,000 patients enrolled in the “ORFAN” registry, the world’s largest study that evaluates coronary computed tomography angiography (CCTA) imaging biomarkers in predicting long-term cardiovascular outcomes.
Key study findings include:

Among patients undergoing CCTA, more than 80% did not have obstructive coronary artery disease (CAD) at the time of imaging, but twice as many fatal and non-fatal cardiac events occurred in that group
Coronary inflammation, as measured by Caristo’s CaRi-Heart FAI-ScoreTM, predicted fatal and non-fatal cardiac events (including heart attack and new heart failure), independently from traditional risk factors, routine clinical CCTA interpretation, calcium scoring and plaque quantification, at least 10 years in advance
Even among the 50% of patients who had no or minimal coronary plaque at the time of the initial CCTA, those with the most abnormal FAI-Score results experienced a 9.5-fold higher risk for cardiac mortality and 5.5-fold higher risk for major adverse cardiac events (MACE)
Caristo’s AI-Risk model, CaRi-Heart Risk Score, outperformed other scores in routine clinical use for prediction of cardiac mortality, and when presented to clinicians, resulted in changes of management decision in 45% of the patients. Most changes were due to clinicians’ decision to target the previously undetected coronary inflammation.

“The ORFAN study is an expanding global registry which will include long-term clinical and outcome data for 250,000 patients from around the world, and we are very pleased to publish these initial results,” said Keith Channon, MD, Professor of Cardiovascular Medicine at the University of Oxford, Caristo’s Chief Medical Officer, and co-author of The Lancet publication. “Coronary inflammation is a crucial piece of the puzzle in predicting heart attack risk. We are excited to discover that CaRi-Heart results performed exceptionally well in predicting patient cardiac events. This tool is well positioned to help clinicians identify high-risk patients with seemingly ‘normal’ CCTA scans.”
Ron Blankstein, MD, Professor of Medicine and Radiology at Harvard Medical School, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and co-author of the publication, commented: “This study, which represents one of the largest studies in the field of CCTA, has important implications for the field of preventive cardiology. I am excited about the potential of the FAI-Score biomarker, which has promising prognostic value beyond existing CT-based methods such as plaque, calcium scoring, and CAD-RADS based interpretation.”  
The study underlines the need for a robust risk prediction tool that can identify vulnerable patients with inflamed coronary arteries, particularly in those without obstructive CAD. This approach would transform CCTA from a test used to triage a minority of patients for further intervention into a prevention tool that guides management for all patients undergoing CCTA.
SCCT Webinar to Feature Study Co-Authors on June 27:
On June 27 at 11am EDT, the Society of Cardiovascular Computed Tomography (SCCT) will host a webinar on The Lancet publication findings to be presented by the lead author, Prof. Charalambos Antoniades, and joined by several co-authors (Prof. Channon, Prof. Stefan Neubauer, Prof. Ed Nicol, Prof. Blankstein and Prof. Milind Desai). The webinar will present the key results from The Lancet publication along with a panel discussion on the implications of this landmark study. Check www.caristo.com in early June for the webinar registration link.
Caristo’s patented CaRi-Heart technology marks a scientific breakthrough that is radically transforming the traditional approach to heart disease prediction, prevention and management. The technology applies advanced AI algorithms to routine coronary computed tomography angiography (CCTA) scans to visualize and quantify coronary inflammation, the otherwise invisible disease mechanism responsible for many fatal heart attacks and strokes. Prior to this publication by The Lancet, earlier validation results showing CaRi-Heart technology’s ability to aid the prediction of heart attacks were published in leading medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research.
The CaRi-Heart® technology is in clinical use in the UK, European Union, and Australia.
About Caristo Diagnostics Limited
Caristo Diagnostics is a global leader in cardiac and vascular disease diagnostics and risk prediction. Founded in 2018 as a spin-out company from the University of Oxford, the world’s #1 research university, Caristo has developed a portfolio of imaging-based and AI-assisted platforms that can be applied to aid the prediction and diagnosis of heart attack, stroke, and diabetes. Caristo has been recognized by Newsweek as one of the best digital health companies, and highlighted by Nature as one of the most exciting science-based companies to have emerged from academic labs. Find Caristo online on its website, LinkedIn and X.
Logo: https://mma.prnewswire.com/media/2054669/4734272/Caristo_Logo.jpg
ContactFrank Cheng, Caristo Diagnostics CEO[email protected]
SOURCE Caristo Diagnostics

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Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer

Coronary/Structural Heart by Comments are Disabled

New Access NT-proBNP Assay Detects Heart Failure Biomarker in Less than 11 Minutes Patient Results Evaluated Within Context of Clinically RelevantAge-Based Cutoffs, Disease Comorbidity Data and Gender ParametersBREA, Calif., May 29, 2024 /PRNewswire/ — Beckman Coulter, a global leader in clinical diagnostics, today announced U.S. Food and Drug Administration clearance of its Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay for the assessment of heart failure in less than 11 minutes on the Beckman Coulter DxI 9000 Immunoassay Analyzer*. The Access NT-proBNP assay aids in diagnosing patients suspected of having acute heart failure in emergency departments as well as assessing the severity and risk stratification of patients with heart failure and acute coronary syndrome.

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The award-winning DxI 9000 Immunoassay Analyzer sets a new standard for today’s busy labs addressing today’s speed, reliability, reproducibility, quality, and menu expansion demands.

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 have heart failure, accounting for approximately 8.5% of all heart disease deaths in the United States. Beckman Coulter’s Access NT-proBNP assay measures concentrations of N-terminal pro B-type natriuretic peptide in serum or plasma that originates in a person’s heart. High levels of natriuretic peptides can indicate heart failure.  

As recommended in the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay provides age-based cutoffs for diagnosis of heart failure to ensure results are evaluated in the appropriate clinical context for each patient. In addition to age, other patient factors such as gender, obesity and kidney failure can affect natriuretic peptide levels. The Access NT-proBNP assay provides clinical performance information for these subsets of patients to assist clinicians’ sample data interpretation and diagnoses.
“We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyzer,” Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter.  “FDA clearance of the Access NT-proBNP assay is just the latest confirmation of the platform’s capability to develop ever increasingly more sensitive and clinically relevant diagnostics. The combination of DxI 9000 Analyzer’s expanding menu of assays and its operational excellence, highlighted by ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe is driving laboratory demand around the globe.”  About Beckman Coulter. Inc. A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher.  Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.Follow and connect with Beckman Coulter Diagnostics via LinkedIn, X, and Facebook.*Full name DxI 9000 Access Immunoassay Analyzer© 2024 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2024-12984.SOURCE Beckman Coulter Diagnostics

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Philips expands global access to its ground-breaking 3D intracardiac echocardiography to Hong Kong

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Philips expands global access to its ground-breaking 3D intracardiac echocardiography to Hong Kong Hong Kong selected as the pioneering international location for integrating Philips’ VeriSight Pro 3D Intracardiac Echocardiography (ICE) catheter into routine clinical practice International roll-out underscores Philips’ commitment to driving healthcare innovation and enhancing patient outcomes worldwide Amsterdam, […]

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Terumo Cardiovascular Announces 510(K) Clearance for the CDI OneView™ Monitoring System

Coronary/Structural Heart by Comments are Disabled

All-new modular, expandable design displays up to 22 vital patient parameters with real-time convenienceANN ARBOR, Mich., May 28, 2024 /PRNewswire/ — Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

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Built on decades of proven technology, Terumo’s new CDI OneView System delivers exceptional performance and convenience for real-time decision making in the cardiovascular operating room. The CDI OneView System measures or displays up to 22 vital patient parameters — including oxygen delivery, cardiac index, area under the indexed oxygen delivery curve, oxygen extraction ratio and measured flow.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO2), oxygen extraction ratio (O2ER), Area Under the DO2 Curve (AUC), and measured arterial oxygen saturation (SaO2).  

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences, while continuing to provide the critical information on which clinicians have come to rely.
“The world’s leading cardiac centers have trusted CDI Systems for over 30 years. With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients,” said Robert DeRyke, President and CEO of Terumo Cardiovascular.  “The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”  New features and functions of Terumo’s latest patient parameter monitoring system were influenced by extensive perfusionist input from leading global cardiovascular institutions. In response to the growing needs of healthcare providers, the new CDI OneView System now provides real-time O2ER, CI, VO2 and DO2 information to help perfusionists maintain a safe threshold for those parameters. Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help to reduce the incidence of acute kidney injury.1, 2About Terumo Cardiovascular Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, Michigan, with manufacturing operations in the U.S., Asia, and Latin America. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.comAbout Terumo Corporation Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.Refer to this device’s Instructions For Use (IFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.9065361.  Oshita, T et al. A Better Predictor of Acute Kidney Injury After Cardiac Surgery: The Largest Area Under the Curve Below the Oxygen Delivery Threshold During Cardiopulmonary Bypass. J Am Heart Assoc. 2020;9: e015566. DOI: 10.1161/JAHA.119.015566.2.  Condello, I, etal. Association between oxygen delivery and cardiac index with hyperlactatemia during cardiopulmonary bypass. JTCVS Techniques. 2020; Vol 2: 92-99.SOURCE Terumo Cardiovascular

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