Allina Health System, Inc.

CHELMSFORD, Mass.--( BUSINESS WIRE )--ZOLL ® , an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has been enrolled in the S uper S aturated oxygen C omprehensive O bservational RE gistry (SSCORE). The prospective study is designed to provide further evidence of the efficacy of SuperSaturated Oxygen (SSO 2 ) Therapy to reduce heart failure and mortality in patients suffering from left anterior descending ST-elevation myocardial infarction (LAD STEMI) heart attacks, the most serious type of heart attack. LAD STEMI heart attacks are often referred to as “widow makers” due to the high mortality rate associated with this condition. Additionally, SSCORE will collect data to substantiate the potential improvement in overall healthcare costs associated with prevention of heart failure versus a lifetime of palliative treatment strategies. The Minneapolis Heart Institute at Abbott Northwestern Hospital, a partner of Allina Health with multiple locations in Minneapolis, Minnesota, is one of the early adopters of the revolutionary SSO 2 Therapy, leading to their prominent position as first enroller in the study. “These patients with LAD occlusion are at significant risk. Opening the artery is the first step but using SSO 2 to further decrease infarct size is vital. This patient had an acute proximal LAD occlusion and I wanted to give him the best chance of preserving his heart function,” stated Dr. M. Nicolas Burke, Director of Cardiovascular Emergency Services at Abbott Northwestern, who treated the first patient enrolled in SSCORE nationwide. “Enrolling the first patient in the SSCORE study marks a significant milestone in advancing the use of SuperSaturated Oxygen Therapy to treat the most severe heart attacks," said Matt Rochner, General Manager of ZOLL TherOx. "SSO 2 Therapy has the potential to not only improve patient outcomes but also reduce the long-term costs of managing heart failure, a significant healthcare challenge. Our partnership with the Minneapolis Heart Institute and Allina Health allows us to advance this cutting-edge technology by collecting more evidence-based clinical and economic data, positioning SSO 2 Therapy to become the standard of care for LAD STEMI patients." Patients with LAD STEMI heart attacks have higher mortality rates than those with other types of heart attacks. SSO 2 Therapy is the first and only FDA-approved treatment that has been clinically proven to significantly reduce damage to cardiac muscle in heart attack patients after coronary angioplasty with stenting. 1 The extent of damaged cardiac muscle is a strong predictor of future outcomes like rehospitalization and the development of heart failure. 2 SSO 2 Therapy is indicated as an adjunct for patients who suffer LAD STEMI and are treated with traditional stenting within six hours of chest pain onset. The therapy delivers high levels of dissolved oxygen (7–10 times the amount normally found in the bloodstream) directly to the damaged heart muscle immediately after the coronary artery has been successfully opened via angioplasty and stenting. Multiple clinical trials have demonstrated the safety and efficacy of SSO 2 Therapy to reduce infarct size, a strong predictor of subsequent outcomes. 1, 3 -6 “The focus on reducing infarct size and improving microvascular function with SSO 2 in the cath lab versus palliation of disease is a logical strategy that has been long awaited in this field,” said Dr. Jay Traverse, Principal Investigator and Researcher at Allina’s Minneapolis Heart Institute Foundation, and an Interventional Cardiologist at Allina’s Minneapolis Heart Institute. “Persistently high readmission rates for these patients, who often develop heart failure following standard-of-care stenting of the LAD, have been an ongoing challenge for over two decades. SuperSaturated Oxygen Therapy has shown great promise to alleviate this problem, which improves the quality of life for the patient while relieving the financial burden on the healthcare system as a whole. We are excited to participate in this trial and look forward to seeing positive outcomes.” About ZOLL ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com . About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com . Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/ . 1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75. 2 Stone GW et al. J Am Coll Cardiol. 2016;67(14):1674–83. 3 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405. 4 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9. 5 https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2020-ICD-10-PCS-Guidelines.pdf 6 Chen S, et al. Catheter Cardiovasc Interv. 2020; 1–7. Copyright © 2024 ZOLL Medical Corporation. All rights reserved. ZOLL and TherOx are registered trademarks of ZOLL Medical Corporation and/or its subsidiaries in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery More than 1.6 million people in the U.S. are affected by tricuspid regurgitation,1 which can severely impact quality of life Data from the TRILUMINATE™ Pivotal trial demonstrated that patients who received TriClip experienced a marked improvement in the severity of their symptoms and quality of life, with benefits sustained at one year ABBOTT PARK, Ill., April 2, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip™ transcatheter edge-to-edge repair (TEER) system that's specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve. This approval follows the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of TriClip outweighed the risks. Experience the full interactive Multichannel News Release here: "The U.S. approval of TriClip is a significant advancement for people suffering from tricuspid regurgitation, a heart condition that negatively impacts their quality of life and puts them at grave risk of serious health issues," said Paul Sorajja, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital and co-principal investigator of the TRILUMINATE™ Pivotal trial. "With TriClip, physicians can offer patients a therapy option backed by excellent safety and effectiveness to help restore tricuspid native valve performance without subjecting them to high-risk open-heart surgery that may not be feasible for individuals with TR who are generally older and sicker." The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart. TR can force the heart to work harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to atrial fibrillation, heart failure, and ultimately, death. For those who continue to have symptoms or persistent TR despite treatment with medical therapy and are not considered good candidates for surgery, TriClip represents an option that can improve a person's quality of life. Delivered through a vein in the leg, TriClip's TEER technology works by clipping together a portion of the leaflets – or flaps of tissue – to repair the tricuspid valve and help blood flow in the right direction without the need for open-heart surgery. On average, people who receive TriClip only need one day in the hospital before they recover and can return home. As part of its approval process, the FDA reviewed findings from the TRILUMINATE Pivotal trial, the world's first randomized, controlled clinical study to evaluate the safety and effectiveness of the TriClip system compared to medical therapy in people with severe TR who are at intermediate or greater risk for open-heart surgery. In the study, 90% of patients who received the TriClip system experienced a marked improvement in their TR grade, reducing from severe or higher to moderate or less at 30 days – a reduction that was sustained at one year. The trial also demonstrated a highly favorable safety profile, with 98% of patients being free of major adverse events through 30 days, and a significant improvement in quality of life. "This approval helps address a treatment gap for people with tricuspid regurgitation who previously had few options to treat a disease that adversely impacted their daily lives and could lead to other deadly conditions," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "With the addition of TriClip to our broad structural heart therapy offerings in the U.S., we are continuing to bring meaningful, life-enhancing benefits to patients with cardiovascular conditions." TriClip leverages the same clip-based technology as Abbott's leading MitraClip™ device – which has treated more than 200,000 people with leaky mitral valves (mitral regurgitation) – but was specifically designed to treat the tricuspid valve's complex anatomy. TriClip has been approved for use in more than 50 countries, including in Europe and Canada, since its initial CE Mark approval in 2020. The device has already been used to treat more than 10,000 people with TR. Abbott offers the industry's most comprehensive portfolio of structural heart solutions. In addition to TriClip, the company's innovative, minimally invasive therapies include first-of-its-kind technologies MitraClip and Amplatzer Piccolo™ Occluder (to close a hole in the heart of babies), as well as the Navitor™ transcatheter aortic valve implantation system (to treat aortic stenosis). Abbott continues to focus on addressing the unmet needs of patients with structural heart disease and advancing standards of care so people can live their fullest possible lives. For U.S. important safety information on TriClip, visit . For U.S. important safety information on MitraClip, visit . For U.S. important safety information on the Amplatzer Piccolo Occluder, visit . For U.S. important safety information on Navitor, visit . 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 114,000 colleagues serve people in more than 160 countries. Connect with us at and on LinkedIn, Facebook, Instagram, X and YouTube. SOURCE Abbott

The Biden Administration has designated the Minneapolis-St. Paul metro and Puerto Rico as medtech hubs in a U.S. Department of Commerce competition for $500 million in funding. The U.S. Department of Commerce’s Economic Development Administration (EDA) designated 31 hubs across the country to drive regional innovation and job creation, the agency said this week. All are eligible to apply for $50-$75 million in funding each. EDA will select five to 10 hubs for funding. The EDA also awarded strategy development grants (SDGs) to fund regional coordination to make them more competitive for future funding. Grant recipients include the Phoenix metro’s Medical Device Manufacturing Multiplier Strategy Development Consortium. EDA-designated tech hubs include regions focused on predictive healthcare, personalized medicine, pharmaceuticals, biopharmaceuticals, biotechnology and biologics manufacturing. Other EDA hubs are working on semiconductors, lithium batteries, sustainable polymers, additive manufacturing, critical minerals, quantum computing, offshore wind energy, nuclear technology, mass timber, and autonomous systems. Boston, for example, is included in the new Ocean Tech Hub of Southeastern New England covering Rhode Island and Massachusetts. That hub is focused on machine learning-enabled robotics and sensors. A full list of the tech hubs and SDG recipients is at the bottom of this post with links to more information. The Minnesota MedTech 3.0 hub The Minnesota MedTech 3.0 hub covers the Minneapolis-St. Paul-Bloomington region, which extends into Western Wisconsin. Led by the Minneapolis Saint Paul Economic Development Partnership (which also calls itself Greater MSP), the hub “aims to position Minnesota as a global center for ‘Smart MedTech’ by integrating artificial intelligence, machine learning, and data science into medical technology,” EDA said in a news release. “Leveraging its medical technology ecosystem and concentration of hospitals, research institutions, and medical device manufacturers, the MedTech Hub 3.0 will work to capitalize on regional assets to drive innovative collaboration in the MedTech sector,” the EDA continued. Greater MSP said the Minnesota MedTech 3.0 coalition will seek funding this winter and hopes to launch new data exchanges for specific diseases and technologies, startup incubators and acelerators, expanded access to medtech infrastructure, workforce strategies and equity initiatives. The Minnesota MedTech 3.0 coalition includes Allina, Boston Scientific, Brown Venture Group, Center for Economic Inclusion, Fogarty Innovation, gener8tor, Governor’s Workforce Development Board and Minnesota Department of Employment and Economic Development, HealthPartners, Mayo Clinic, Medica, Medical Alley Association, Metropolitan Economic Development Association, Medtronic, Minnesota State, Minnesota Technology Association, MN SBIR, MSP Equity Fund, Shakopee Mdewakanton Sioux Community, State of Minnesota–Office of Governor Tim Walz, University of Minnesota, and Vensana Capital. “Medtronic is proud to be a leader in Minnesota MedTech 3.0 alongside so many other great partners,” Medtronic Chair and CEO Geoff Martha said in a Greater MSP news release. “This is a tremendous opportunity for Minnesota, and we’re committed to using our resources to ensure the success of this Tech Hub.” Puerto Rico’s PRBio Tech Hub The Puerto Rico Science, Technology and Research Trust leads the PRBio Tech Hub, which “will advance the region as a global leader in biotechnology through fast-tracking the discovery, development, manufacturing, and supply of next-generation biotechnology and medical device products to detect, treat, and cure diseases and ailments,” EDA said in a news release. The PRBio Tech Hub also won an SDG to “increase local coordination and planning activities to strengthen its region’s capacity to manufacture, commercialize, and deploy critical technologies.” New Hampshire’s ReGen Valley Tech Hub The Advanced Regenerative Manufacturing Institute leads the ReGen Valley Tech Hub, which “aims to make New Hampshire a global leader in biofabrication to produce cost-effective regenerative therapies that address chronic disease and organ failure,” EDA said in a news release. “Amidst growing commercial demand for these therapies and building on a recent EDA Build Back Better Regional Challenge award, this Tech Hub seeks to advance biofabrication-related therapies, invest in manufacturing facilities, and incubate technology startups to secure domestic regenerative therapy development and biofabrication,” the EDA continued. Ohio’s Sustainable Polymers Tech Hub