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Enrollment completed ahead of schedule in the global IDE for Abbott's Volt™ PFA SystemGlobal FOCALFLEX trial now underway for Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, receives U.S. Food and Drug Administration clearance, begins commercial launchABBOTT PARK, Ill., Oct. 10, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) announced today it has achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE Study supporting the Volt™ PFA System, and the launch of the FOCALFLEX trial to assess the company's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (SE), which will be used in the treatment of patients with paroxysmal atrial fibrillation. Together, these two studies represent significant advances for the future of two Abbott PFA catheters, which are being developed as important tools for physicians treating people with abnormal heart rhythms like atrial fibrillation (AFib). In addition, Abbott also announced U.S. Food and Drug Administration (FDA) clearance of the company's Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, which will further support mapping of both PFA and radiofrequency (RF) ablation cases, where visualization of cardiac anatomy is critical to ensure the best outcomes for people undergoing ablation procedures. "It was exciting to participate in the VOLT-AF IDE Study to help assess a next-generation PFA catheter that incorporates new design concepts we believe will advance PFA technology and improve patient outcomes," said Monica Lo, M.D., an electrophysiologist with Arkansas Heart Hospital who specializes in complex arrhythmias. "Only through studies like VOLT-AF and Abbott's new FOCALFLEX trial, can we fully understand and safely deploy the next generation of AFib treatments to help people enjoy life free from complex heart rhythm conditions." New Advancement in Pulsed Field Ablation, Treating AFibHistorically, patients requiring a cardiac ablation procedure to treat conditions like AFib received RF ablation, which uses heat to destroy tissue responsible for erratic heart signals, or cryogenic ablation, which freezes tissue. Instead of heat or extreme cold, PFA uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy. PFA represents a promising opportunity to treat people with abnormal heart rhythms with new technology that may offer safety advantages* that can reduce known risks of traditional ablation therapies. However, existing early-generation PFA systems have limitations, including the lack of three-dimensional visualization and coupling with a 3D cardiac mapping system*. Other limitations that Abbott's PFA systems were designed to address include no indication of catheter-tissue contact and repeat ablations to ensure favorable patient outcomes*. Increased interest in Abbott's PFA system propelled enrollment in the U.S. VOLT-AF IDE Study to be completed four months ahead of the anticipated timeline, enrolling almost 400 patients in just three months. Abbott's investigational Volt PFA System was designed to overcome prior limitations in PFA systems by pairing a balloon-in-basket catheter with Abbott's EnSite™ X EP System, an industry-leading heart mapping solution. The unique basket shape of the catheter's energy delivery area paired with the balloon are designed to effectively transfer Abbott's optimized waveform energy to the tissue by ensuring better catheter contact and stability during the procedure*. Another unique feature of Abbott's PFA catheter is how the platform's PFA generator and the EnSite X EP System are designed to give physicians the ability to specifically target lesions and ablate the exact area(s) of the heart that are triggering arrhythmia. In addition to the VOLT-AF IDE Study, Abbott's global FOCALFLEX Pulsed Field Ablation Study is also now underway to assess the company's TactiFlex Duo Ablation Catheter, Sensor Enabled. This catheter is designed as a dual-energy ablation solution offering both PFA and RF energy delivery, and will also be assessed in the FLEXPULSE IDE, which is expected to launch in the U.S. soon, with about 200 patients at 25 sites. Where the Volt PFA System is designed as a "single shot" PFA approach, the TactiFlex Duo Ablation Catheter, SE is a "focal" or "point-by-point" approach that aims to deliver the safety and efficiency of PFA with more flexible and focused energy. Designed on Abbott's TactiFlex Ablation Catheter, Sensor Enabled, known for its stability during procedures due to its novel flexible tip, the TactiFlex Duo Ablation Catheter, SE aims to offer physicians another option for delivering PFA and/or RF to patients with greater versatility to precisely target specific areas of tissue within the heart. "There's immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique," said professor Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with the TactiFlex Duo Ablation Catheter, Sensor Enabled for the FOCALFLEX trial. "Abbott improved upon limitations of first-generation systems and has successfully advanced its approach to PFA beyond those initial systems that have come to market." Abbott's Advanced Cardiac Mapping Solutions Support Improved OutcomesAs ablation innovations evolve, a key element of effective treatment continues to be the use of heart mapping. Accurate mapping for RF procedures has been critical in electrophysiology, and the adoption of mapping for PFA procedures continues to grow. Abbott has seen increased reliance on its mapping technology as more physicians begin to explore the use of PFA for patients. With its recent FDA clearance, the Abbott Advisor HD Grid X Mapping Catheter, Sensor Enabled, offers a first-of-its-kind electrode configuration for high-density heart mapping. This design is intended to make physicians more aware of electrical signals of the heart, regardless of catheter placement during an ablation procedure. For U.S. important safety information go to:TactiFlex™ Ablation Catheter, Sensor Enabled™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter/indications-safety-warnings.html Advisor™ HD Grid Mapping Catheter, Sensor Enabled™https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/diagnostic-catheters/advisor-hd-grid/about.html EnSite™ X EP Systemhttps://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html Investigational/Under-Development Products*Devices or products referenced are INVESTIGATIONAL and/or UNDER DEVELOPMENT. Product specifications or proposed intended uses are design goals and subject to change. About AbbottAbbott 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 www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.   SOURCE Abbott

AUSTIN, Texas, March 13, 2024 /PRNewswire/ -- Arkansas Heart Hospital, a leader in prevention, diagnosis, and treatment of cardiovascular disease, is extending its use of Oracle Health electronic health records (EHR) and RevElate Patient Accounting solutions across its network of ambulatory clinics and two hospitals. Together with its existing Oracle Fusion Applications for finance and supply chain, Arkansas Heart will have a centralized health and operational management solution across all its facilities. This will help the network more easily share important data, improve staff and patient experiences, and better align resources with patient needs. Continue Reading "By extending Oracle technology across our organization, we are putting information into the hands of our staff that is vital for the care of our patients in moments where every second counts.” "Since we opened nearly 27 years ago, innovation has been a driving force that separates Arkansas Heart from the competition," said Bruce Murphy, MD, PhD, CEO and founder, Arkansas Heart Hospital. "Oracle shares our commitment to transforming healthcare for the betterment of patients, staff, and the communities we serve. By extending Oracle technology across our organization, we are putting information into the hands of our staff that is vital for the care of our patients in moments where every second counts." Cardiovascular disease in the U.S. is on the rise, causing 17 million deaths worldwide each year, and is expected to rise to more than 23 million by 20301. By extending its 10-year relationship with Oracle Health, Arkansas Heart can improve how its staff works and delivers care by having a single, longitudinal health record for each patient, no matter which Arkansas Heart facility they visit. In tandem, Oracle Fusion Cloud Enterprise Resource Planning (ERP) and Oracle Fusion Cloud Supply Chain & Manufacturing (SCM) are providing the network standardized business processes on a single platform that is helping to increase productivity, reduce costs, and improve employee experience. Leveraging Oracle as a single resource for its clinical and enterprise operations helps Arkansas Heart further embrace future advancements in artificial intelligence (AI) technologies that can automate documentation, support a clinically driven revenue cycle approach, improve efficiencies, and embrace the innovation that has been a hallmark of Arkansas Heart Hospital for years. "Many healthcare networks today are operating with outdated technology that silos data and processes, making it difficult to adapt to new solutions that offer important clinical and financial insights," said Seema Verma, executive vice president and general manager, Oracle Health and Oracle Life Sciences. "With an intuitive, connected digital health record system that spans its operations, together with Fusion Applications, the Arkansas Heart team will have ready access to the information needed to better serve patients, clinicians, and staff." To see Oracle Health in action, please visit us at HIMSS in Orlando March 11 - 15 at booth #2761. Learn how Oracle Health is building an open healthcare platform with intelligent tools for data-driven, human-centric health experiences to connect consumers, providers, payers, public health, and life sciences. About Oracle Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at . Trademarks Oracle, Java, MySQL and NetSuite are registered trademarks of Oracle Corporation. NetSuite was the first cloud company—ushering in the new era of cloud computing. 1 Cardiovascular diseases (who.int) SOURCE Oracle

REDWOOD CITY, CA / ACCESSWIRE / June 5, 2023 / Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced the successful completion of the first clinical cases with the new Tigereye ST image-guided CTO crossing system. Dr. Ian Cawich, an interventional cardiologist at Arkansas Heart Hospital, and Dr. Jaafer Golzar, an interventional cardiologist at Advocate Christ Medical Center and Avinger's Chief Medical Officer, performed the first cases with the new system. Since the initiation of limited launch in May, four physicians at 5 U.S. hospital sites have successfully used Tigereye ST to treat CTOs in 14 separate procedures across a variety of lesion types and locations both above and below the knee. Following his initial experience with Tigereye ST, Dr. Cawich noted, "As a long-time user of Avinger's image-guided CTO crossing and atherectomy platforms, I firmly believe that onboard visualization during these interventions leads to better outcomes for patients. Tigereye ST combines real-time OCT imaging with a powerful crossing catheter to safely treat challenging lesions, while minimizing the use of radiation and contrast dye for these types of procedures." Dr. Golzar added, "I successfully used Tigereye ST in both de novo and restenotic in-stent CTOs both above and below the knee. While still early in our experience, I am extremely encouraged with the potential power of this system, as it represents one of the most significant technological advancements Avinger has made." Jeff Soinski, Avinger's President and CEO, commented, "These initial case experiences offer early validation for the improvements brought to the platform by Tigereye ST. Based on our early success with the device, we plan to expand the limited launch to several additional sites in June and anticipate progressing to full commercial availability in the third quarter. We are excited about the results physicians are delivering for their patients in these first cases and the potential for Tigereye ST to be a significant growth driver for our image-guided CTO crossing portfolio." Tigereye ST expands and advances Avinger's proprietary image-guided CTO product line with compelling new features and benefits. Tigereye ST incorporates design upgrades to the tip configuration and catheter shaft to increase crossing power and procedural success in challenging lesions, as well as design enhancements for ease of image interpretation during the procedure. Product specifications include a working length of 140 cm, 5 French sheath compatibility, and low crossing pro treatment of lesions in the peripheral vessels both above and below the knee. Avinger's proprietary Lumivascular technology allows physicians to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, due to real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation. About Avinger, Inc. Avinger is a commercial-stage medical device company that designs and develops the first and only image-guided, catheter-based system for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD). PAD is estimated to affect over 12 million people in the U.S. and over 200 million worldwide. Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox series of imaging consoles, the Ocelot and Tigereye™ family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit . Follow Avinger on Twitter and Facebook. Forward-Looking Statements This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our planned launch of Tigereye ST, patient and physician benefits of Tigereye ST, expected growth resulting from the launch and physician adoption of Tigereye ST, and the timing of commercial availability of Tigereye ST. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include the resource requirements related to our products; the timing and outcome of product launch; as well as the other risks described in the section entitled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2023, as amended, and Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Avinger disclaims any obligation to update these forward-looking statements. Investor Contact: Matt Kreps Darrow Associates Investor Relations (214) 597-8200 mkreps@darrowir.com Public Relations Contact: Phil Preuss Chief Marketing Officer Avinger, Inc. (650) 241-7900 pr@avinger.com SOURCE: Avinger, Inc. View source version on accesswire.com: