The Latest Cardiac and Vascular News
DUBLIN–(BUSINESS WIRE)–Favorable patient outcomes from the TANDEM I first-in-human clinical trial of the CroíValve DUO™ System for the percutaneous treatment of tricuspid regurgitation (TR) were presented today by Professor Wojciech Wojakowski at the New York Valves 2024 scientific conference. The DUO System is a novel transcatheter coaptation valve that works […]
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), a leader in AI-driven precision cardiovascular medicine, today announced the successful completion of its System and Organization Controls (SOC) 2 Type I audit, achieving compliance with the leading industry standards for customer data security. This milestone underscores the Company’s unwavering commitment to the highest […]
DAYTON, Ohio–(BUSINESS WIRE)–MedsEngine and NI Medical are pleased to announce they will be presenting a comprehensive analysis on their management of hypertension at the European Society of Cardiology 2024 meeting in London. The impact of combining NICaS hemodynamic data with MedsEngine clinical decision support software reveals a significant reduction in […]
CLEARWATER, Fla., June 7, 2024 /PRNewswire/ — Morton Plant Hospital recently completed its first robotic-assisted, minimally invasive coronary artery bypass surgery (CABG), making it one of only two hospitals in the Tampa Bay area to offer robotic-assisted CABG. Morton Plant Hospital was ranked #1 in Florida for Cardiac Surgery in 2023 by Healthgrades. Cardiothoracic Surgeon Michael Kayatta, MD, and his partner, Cardiovascular Surgeon John Ofenloch, MD, performed the procedure earlier this week, with the assistance of their highly skilled surgical team.
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Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.
CABG surgery is needed when plaque has built up in arteries carrying blood to the heart causing the arteries to be severely narrowed. The surgeon creates a new path for blood to flow by using a healthy artery or vein from another part of the body and connects it past the blockage on the heart.
In a traditional CABG, the surgeon cuts open the chest by dividing the breastbone and spreads the ribs to expose the heart. The heart is stilled, requiring the patient to be on a heart-lung machine during the surgery. Full recovery often takes about two months. The robotic-assisted CABG only requires four small incisions between the ribs. A small camera and surgical tools are attached to the robotic arms and guided through the incisions. The heart continues to beat through the procedure, with special tools stabilizing a part of the heart.Cardiothoracic Surgeon Michael Kayatta, MD (center) works with his surgical team to prepare for Morton Plant Hospital’s first robotic-assisted coronary artery bypass surgery.The computer console, which shows images of the heart magnified up to 10 times normal vision, gives the surgeon the ability to guide the surgical instruments, attached to the robotic arms, with his fingers while watching the screen. The robotic arms that are controlled by the surgeon have greater range of motion and are more precise than human arms. A major potential benefit of a robotic-assisted CABG is a quicker recovery for the patient. The smaller incisions should also result in less scarring. “We are excited to bring this new technology to patients at Morton Plant Hospital,” said Dr. Kayatta. “Many people hear robot and think a machine will be doing the surgery. We have a highly skilled, experienced team performing each surgery. The robot is simply a tool that helps us to treat more patients and get them back to their life in weeks rather than months.” Drs. Kayatta and Ofenloch are both with BayCare Medical Group’s Cardiovascular and Thoracic Surgery clinic in Clearwater. For more information on heart and vascular services at BayCare: Heart and Vascular Services.About BayCareBayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.org.SOURCE Morton Plant Hospital
SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036. The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart. BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke. BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. “Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” And in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
CLEVELAND – A new, robotic approach to heart bypass surgery is now being offered to patients at University Hospitals (UH) with great success. Two UH Harrington Heart & Vascular Institute providers, Dr. Kelsey Gray and Dr. Pablo Ruda Vega, are currently the only surgeons in Ohio performing this specific type […]
What every student-athlete should knowMISSION, Kan., June 6, 2024 /PRNewswire/ — (Family Features) You may find it difficult to wrap your mind around the idea of an energetic student-athlete with a cardiac diagnosis. Heart conditions may be more often associated with older individuals, but you might be surprised to learn hypertrophic cardiomyopathy is the most common condition responsible for sudden cardiac death in young athletes. In fact, it’s the cause of 40% of sudden cardiac death cases.
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Photo courtesy of Shutterstock
Photo courtesy of Shutterstock
It’s estimated 1 in every 500 adults living in the United States has hypertrophic cardiomyopathy, according to the American Heart Association, but a significant percentage are undiagnosed. More than 80% of individuals who experience this condition show no signs or symptoms before sudden cardiac death. While sudden cardiac death is rare, it can occur during exercise or in its aftermath. That’s why it’s important for student-athletes and their loved ones to learn more about this condition and talk to a doctor about their risk.
With proper knowledge and the support of a skilled care team, it’s possible to manage hypertrophic cardiomyopathy with heart-healthy actions to prevent complications or worsening cardiovascular conditions like atrial fibrillation (a quivering or irregular heartbeat), stroke or heart failure. Hypertrophic cardiomyopathy awareness and education for athletes by the American Heart Association is made possible in part by a grant from the Bristol Myers Squibb Foundation.
What is hypertrophic cardiomyopathy?Hypertrophic cardiomyopathy is the most common form of inherited heart disease and can affect people of any age. It’s defined by thickening and stiffening of the walls of the heart. The heart’s chambers cannot fill up or pump blood out adequately, so the heart is unable to function normally.There are different types of this condition. Most people have a form of the disease in which the wall that separates the two bottom chambers of the heart (the septum) becomes enlarged and restricts blood flow out of the heart (obstructive hypertrophic cardiomyopathy).However, sometimes hypertrophic cardiomyopathy occurs without significant blocking of blood flow (nonobstructive hypertrophic cardiomyopathy). The heart’s main pumping chamber is still thickened and may become increasingly stiff, reducing the amount of blood taken in then pumped out to the body with each heartbeat.What are possible symptoms?Symptoms can include:
shortness of breath
chest pain
heart palpitations
fatigue
The severity of symptoms can vary, but if you experience them or if you have a family history of hypertrophic cardiomyopathy or sudden cardiac death, it may be a good idea to speak to your doctor about whether you have this condition.For some people, symptoms can get worse and new symptoms can appear over time, resulting in people dealing with harsher effects and a diminished ability to do the activities they love. This decrease in functions can be one of the most challenging aspects of the disease. Keeping your health care team aware of any new or changing symptoms allows them to work with you to develop a plan to manage these symptoms and reduce their impact.How is hypertrophic cardiomyopathy diagnosed?Medical history, family history, a physical exam and diagnostic test results all factor into a diagnosis. A common diagnostic test is an echocardiogram that assesses the thickness of the heart muscle and observes blood flow from the heart.If anyone in your family has been diagnosed with hypertrophic cardiomyopathy, other heart diseases or has been told they had thick heart walls, you should share that information with your doctor and discuss the need for genetic testing. Because this condition is hereditary, first-degree relatives, which include siblings and parents, should be checked.Learn more at heart.org/HCMStudentAthlete.Photos courtesy of ShutterstockMichael French[email protected]1-888-824-3337editors.familyfeatures.comAbout Family Features Editorial SyndicateA leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com.SOURCE Family Features Editorial Syndicate
Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet. Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications. At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL. "The ease of use and hemodynamics were impressive" commented Pradeep K. Yadav, MD. "On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning. The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability." The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon.The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil."This initial data is striking and potentially heralds a new age for TAVR," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. "The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible. From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients. We are truly on the precipice of surgical-like outcomes with the Siegel THV!!"About MiRus, LLC.MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.* MiRus® , Siegel™ are all trademarks of MiRus, LLC. Contact:Pam CowartVP of Clinical Affairs[email protected]770-861-4804SOURCE MiRus
Echo IQ’s EchoSolv-AS decision-support software for cardiology delivers significant potential benefits to hospital networks according to independent scientific presentation at prestigious New York Valves scientific conference.
NEW YORK, June 6, 2024 /PRNewswire/ — At the Structural Heart Summit New York Valves earlier today, Dr. Pedro Covas (Baylor Scott & White, The Heart Hospital Plano TX) delivered the scientific presentation: AI-Powered Cardiac Ultrasound Improves Identification of High-Risk Aortic Stenosis (Echo IQ).
Dr. Covas highlighted the unmet need for an AI system for aortic stenosis – a form of heart valve disease characterised by high rates of mortality when untreated. He revealed that the condition is underdiagnosed and undertreated worldwide, partly due to the complexity in the diagnosis of severe aortic stenosis (including low-flow states), and that there is a need for assistance to improve rates of diagnosis. As backed up by the research presented by Dr. Covas, Echo IQ uses artificial intelligence to aide in identifying a high-risk phenotype of aortic stenosis, to ultimately help with timely diagnosis and treatment.
LEARN HOW ECHO IQ USES AI TO SUPPORT ENHANCED DISEASE DETECTION:
The independent research presented by Dr. Covas considered whether artificial intelligence could improve accuracy and reproducibility of diagnosis of severe aortic stenosis in a real-world hospital setting. To test this, Echo IQ’s technology (EchoSolv) was applied to the echocardiographic report data of one of Baylor Scott & White’s leading academic heart hospitals over a 7-month period with a subset of the assessments adjudicated via comprehensive image review by expert cardiographers.
The findings showed EchoSolv to be successful in identifying more patients at risk of aortic stenosis than human-only diagnosis. Specifically,
EchoSolv accurately identified 15% more patients with severe aortic stenosis than human-only diagnosis
Where initial underdiagnosis occurred, patients were found to have a “low flow” state of disease in 30% of cases (subsequently identified by EchoSolv)
The research concluded that:
Echo IQ’s technology can automatically identify aortic stenosis patients at-risk using only echocardiographic measurement data.
Echo IQ’s technology has the potential to improve diagnostic rates of severe aortic stenosis, particularly in low flow states.
There are important implications for less specialized cardiology centers, where echocardiographers are likely to benefit the most from automated diagnosis of severe AS.
Echo IQ Chief Medical Advisor, Professor David Playford said: “This kind of independent research demonstrates exactly how Echo IQ’s artificial intelligence can help healthcare professionals identify patients with severe cases of aortic stenosis as well as those with significant risk of disease. Diagnosing aortic stenosis accurately, and in a timely fashion, is extremely complex and the findings shared by Dr. Covas show clearly how Echo IQ’s artificial intelligence can help improve clinical performance.”
About Echo IQ
Echo IQ uses artificial intelligence for decision support in structural heart disease. The company’s first fully AI-enabled solution has been submitted for final FDA clearance. The company is headquartered in Sydney, Australia and is publicly listed on the Australian Securities Exchange (ASX:EIQ). Don Fowler is President, Echo IQ USA, and is based in Austin, TX.
SOURCE Echo IQ Limited
KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., a leader in AI-powered blood tests for cardiovascular diagnostics, has been selected to join the 2024 Accelerator Cohort of MedTech Innovator, the world’s largest accelerator for medical technology companies. This honor places Prevencio among the top 5% of 1,300 applicants, reflecting the company’s innovative approach to […]
