The Latest Cardiac and Vascular News
V-Wave’s Novel and Minimally Invasive Interatrial Shunt is Designed to Treat Heart Failure and Addresses Significant Treatment Gap Device Further Strengthens Johnson & Johnson MedTech’s Position in Cardiovascular August 20, 2024 07:30 AM Eastern Daylight Time NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson1 (NYSE: JNJ) today announced that it has entered into […]
BURLINGTON, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) — LeMaitre (Nasdaq:LMAT), a provider of vascular devices, implants and services, today reported Q2 2024 results, announced a $0.16/share quarterly dividend and provided guidance.
– ATEV demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis –
CLEVELAND – A novel study co-authored by a heart failure cardiologist at University Hospitals Harrington Heart & Vascular Institute, demonstrates the effectiveness of a newly developed scoring system in identifying patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The study, “An Evidence-Based Screening Tool for Heart Failure with Preserved […]
Brings extensive experience in design, development, and implementation of US medtech clinical trial strategy for hemodialysis and vascular access Follows expansion of Xeltis’ clinical presence in the US after recent IDE approval for aXess™ US pivotal trial EINDHOVEN, Netherlands, July 23,…
CALGARY, AB, July 16, 2024 /PRNewswire/ — Circle Cardiovascular Imaging (“Circle” or the “Company”), the global leader in AI-driven cardiovascular imaging solutions, today announced that Erkan Akyuz has been appointed Chief Executive Officer, effective August 5, 2024. He will succeed Circle co-founder and CEO Greg Ogrodnick, who is stepping down after successfully leading the Company for more than 16 years.
Akyuz brings extensive leadership experience in healthcare and imaging technology, having served as President and CEO at major healthcare and medical systems companies including Rhapsody, Change Healthcare and Toshiba Medical Systems, where, under his leadership, the companies experienced improved profitability, customer retention and growth. Recognized for his ability to transform business models, Akyuz combines his technological background with his strategic prowess to drive operational excellence.
“I have long admired Circle and its role at the forefront of the medical imaging industry, offering best-in-class AI-powered solutions to hospitals, physicians and patients on a global scale,” said Erkan Akyuz. “I am thrilled to be joining this impressive team and look forward to leading Circle as we continue to advance our mission of improving patient outcomes worldwide.”
Akyuz is joining Circle, the leading provider of AI-based cardiac imaging and reporting solutions, during a period of accelerated growth and product innovation. Since Thoma Bravo’s investment in Circle in April 2022, the Company has expanded its global footprint from approximately 50 countries to over 90 countries and has continued to innovate on its cutting-edge AI-driven solutions. Earlier this year, Circle launched its next generation platform, cvi42 6.1, which is centered around growing with the medical field with a focus on accessibility, interoperability and efficiency.
“On behalf of the Thoma Bravo team, I want to thank Greg for his unwavering leadership and commitment to innovation that led Circle to become the category leader that it is today,” said Carl Press, a Partner at Thoma Bravo. “Under Greg’s stewardship, Circle transformed from a university-led research project into a market leading diagnostic platform that has benefitted tens of thousands of cardiology patients globally. We are humbled by the impact that he has made in the world of medical imaging and are truly grateful for our partnership with him. At the same time, we are thrilled to welcome Erkan to Circle and look forward to working closely together as we build on a strong foundation and continue to drive product innovation and growth globally.”
“It has been a privilege to lead the dedicated and passionate team at Circle, and I am proud of what we have achieved together,” said Greg Ogrodnick. “I’m confident that Erkan is the right person to lead Circle in the next phase of its journey, and I look forward to watching the Company’s continued success.”
About Circle Cardiovascular Imaging Inc.
Circle Cardiovascular Imaging (Circle) is a Canadian-based company that was founded in 2007, established with the aim of developing innovative software solutions to enhance cardiovascular imaging analysis and improve patient care. Circle’s imaging platform provides best-in-class cardiovascular image reading and reporting for cardiac MR, cardiac CT, cardiac interventional planning, and electrophysiology.
At the heart of everything we do is our unrelenting drive to continually offer better solutions for healthcare providers that improve healthcare outcomes. This fuels our creativity, informs our decisions and is the reason we are passionate about our work. Our roots are medical and digital, our passion is contagious, and our people are amongst the best.
Annually, millions of cardiac exams – in over 1700 hospitals and in more than 90 countries – are estimated to be interpreted using cvi42. For additional information, please visit www.circlecvi.com or contact: [email protected]
SOURCE Circle Cardiovascular Imaging Inc.
ARCH-AI Can Help Radiology Sites Safely and Effectively Implement AI in Daily Practice
RESTON, Va., June 26, 2024 /PRNewswire/ — The American College of Radiology® (ACR®) today launched the ACR Recognized Center for Healthcare-AI (ARCH-AI), the first national artificial intelligence quality assurance program for radiology facilities.
The program, built on best practices, outlines expert consensus-based building blocks of infrastructure, processes and governance in AI implementation in real-world practice.
By working toward, and attesting to, compliance within the tenets of the program, participation in ARCH-AI can help radiology practices provide safe and effective implementation of AI products and help radiologists provide better patient care.
“AI is different from previous technologies,” said Christoph Wald, MD, PhD, MBA, FACR, vice chair of the ACR Board of Chancellors and chair of the ACR Commission on Informatics. “Even a U.S. Food and Drug Administration-cleared AI product must be tested locally to ensure it works safely and as intended. Practice leaders must put safeguards in place to maximize the benefit of AI products while minimizing risk; ARCH-AI is a low-cost, efficient system to help sites do that.”
ARCH-AI site recognition criteria include:
Establishing an interdisciplinary AI governance group.
Maintaining an inventory of AI algorithms with detailed documentation.
Ensuring adherence to security and compliance measures.
Engaging in diligent review and selection of AI algorithms.
Documenting use cases and training procedures.
Monitoring algorithm performance, including safety and effectiveness.
Contributing to the “Assess-AI” central AI registry for performance benchmarking.
“ARCH-AI can help radiology practices structure QA processes that help them plan for what can go wrong, including the development of good AI governance practices, acceptance testing and effectiveness monitoring of AI products to ensure they continue to function as expected over time,” said Keith J. Dreyer, DO, PhD, FACR, ACR Data Science Institute® (DSI®) chief science officer.
Radiology practices that complete the ARCH-AI process will receive an ACR Recognition badge to display in their waiting rooms and lobbies to demonstrate to their communities, patients, payers and referring physicians that they are committed to integrating AI in a safe, responsible manner that allows them to provide the best possible modern healthcare.
“ARCH-AI provides a great blueprint and assists radiology facilities with AI implementation,” said Bibb Allen Jr., MD, FACR, ACR DSI chief medical officer. “DSI also offers AICentral.org, a database of FDA-cleared imaging AI products, and Assess-AI, the ACR’s AI registry that can support local AI acceptance testing and monitoring. These ACR programs can help practices meet ARCH-AI standards and receive meaningful guidance and assistance in implementing AI in a safe and effective manner for their patients.”
SOURCE American College of Radiology
KNOXVILLE, Tenn., June 26, 2024 /PRNewswire/ — Fort Sanders Regional Medical Center, a member of Knoxville-based Covenant Health, was the first hospital in the state of Tennessee to adopt revolutionary diagnostic technology that provides clinicians with a patient’s physiology results in just a few minutes.
Coronary heart disease is one of the top killers of adults in the U.S. and particularly the Southeast. Quick diagnosis and intervention are key to treating cardiac patients who are suffering from heart disease, heart attack, or other events causing blockages in arteries that can be life-threatening.
Fort Sanders Regional’s cardiac catheterization lab is staffed around the clock, 24/7, treating both heart patients who have been admitted to the hospital and those who are having outpatient procedures.
When a patient presents with a potential artery blockage, the heart team at Fort Sanders Regional can use a new tool that shows doctors exactly what percentage of an artery is blocked. The CathWorks FFRangio ® System is a computer-based technology that uses routine angiograms (images) of a patient’s heart structure to create a 3D model showing the location and degree of any blockages and their coronary arteries. This helps providers more quickly diagnose and intervene as needed, including determining whether the patient needs a stent and where the stent should be placed in the heart structure.
Fractional flow reserve (FFR) is a diagnostic measurement that evaluates the physiologic impact of coronary artery narrowing due to cholesterol plaque. It is an important part of the decision-making process to decide if a stent placement is indicated and the length of the stent when managing patients with coronary artery disease (CAD).
In contrast to traditional FFR, the FFRangio System combines artificial intelligence (AI) and advanced computational science to obtain quick and reliable FFRangio values from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. The system provides physicians intraprocedural FFRangio values for all coronary arteries.
Josh Todd, MD, interventional cardiologist at Fort Sanders Regional, said, “With this new tool, interventional cardiologists can perform clinical assessments quicker, more comprehensively, without medications, and in a way that’s seamless and more efficient to the patient. This cutting-edge technology will transform how cardiovascular disease is diagnosed and treated.”
To view the full release, visit https://www.covenanthealth.com/blog/cathworks-technology/.
SOURCE Covenant Health
June 20, 2024 10:47 AM Eastern Daylight Time CHICAGO–(BUSINESS WIRE)–Today GE HealthCare (Nasdaq: GEHC), a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, and MediView XR Inc., a leading clinical augmented reality med-tech company, announced the successful first installation and clinical cases using the OmnifyXR Interventional Suite1 at North […]
HANGZHOU, China, June 14, 2024 /PRNewswire/ — Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine. This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center.
Continue Reading
This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.
The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve’s registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.”We’re honored to be part of the VenusP-Valve PROTEUS trial,” said Prof. Scott Lim after the procedure. “We’ve just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.” “That went really smoothly in this teenage patient with free pulmonary insufficiency”, commented Prof. Michael Hainstock. “I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.””The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, General Manager and CEO of Venus Medtech. “The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”About VenusP-ValveAs the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.About Venus MedtechVenus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.For more information, please visit https://www.venusmedtech.com
*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.
*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.
*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.
Copyright 2024. Venus Medtech (Hangzhou) Inc. All Rights Reserved.
Contacts:Jill Liu Public Relations [email protected]Ophelia ChenInvestor Relations[email protected]SOURCE Venus Medtech (Hangzhou) Inc.
