Mitral Valve Insufficiency

Panel of independent experts reviewed data from the TRILUMINATE™ pivotal trial demonstrating safety, effectiveness and quality-of-life benefits of the TriClip system An investigational device in the U.S., TriClip is approved in more than 50 countries and has treated more than 10,000 people with tricuspid regurgitation worldwide ABBOTT PARK, Ill., Feb. 13, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott's TriClip™ transcatheter edge-to-edge repair (TEER) system outweighed the risks for the treatment of people with tricuspid regurgitation (TR). The panel's decision was based on clinical data from the TRILUMINATE™ pivotal trial, as well as expert testimony. The panel's vote will be considered by the FDA when making a decision regarding the approval of TriClip, a first-of-its-kind minimally invasive device specifically designed to treat the difficult-to-access tricuspid valve. "Tricuspid regurgitation can put added strain on the heart and lead to other cardiovascular issues, which can significantly worsen a person's quality of life, but historically there have been few treatment options," said Lars Søndergaard, M.D., chief medical officer and divisional vice president of medical affairs of Abbott's structural heart business. "Abbott recognized the unmet need for people with this condition and explored the use of our proven clip-based technology to find a truly life-changing intervention. TriClip offers an urgently needed alternative that is safe and effective for people who require tricuspid valve repair but are not able to withstand surgery." 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. 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 a potentially new 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. After reviewing data from Abbott's TRILUMINATE pivotal trial and listening to testimony, the panel voted on the device's safety, effectiveness and risk/benefit profile as a treatment for TR. On the question of whether there is enough data to support the safety of the device, the vote was 14 to 0 in favor. On the separate question of whether there is reasonable assurance that the device is effective, the vote was 12 to 2 in favor. On the final question of the benefit of TriClip versus the risk, the vote was 13 to 1 in favor. "Tricuspid regurgitation can cause fatigue, shortness of breath, irregular heart rhythms, swelling and organ dysfunction. As the disease progresses, it is often debilitating and impacts a person's ability to live the life they want," said David Adams, M.D., chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, who served as co-principal investigator of the TRILUMINATE pivotal trial. "In the TRILUMINATE pivotal trial, we found that 90% of people who received tricuspid valve repair with the TriClip implant experienced a marked improvement in the severity of their TR with unprecedented procedural safety, and their improvement in quality of life was sustained at one year. The TriClip system ushers in a new era of structural therapy for patients suffering from severe tricuspid valve disease." Abbott submitted its pre-market approval (PMA) application for the TriClip device in March 2023 to the FDA, which lead to today's advisory committee panel for expert advice on the device's clinical safety, effectiveness, risk and benefit. The FDA routinely seeks input from advisory committees, especially for first-of-a-kind medical devices. The FDA's decision on Abbott's TriClip is expected in 2024. TriClip is approved for use in more than 50 countries, including in Europe and Canada, and has already been used to treat more than 10,000 people with TR. It is an investigational device in the United States. 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™ (to treat leaky valves in people with mitral regurgitation) 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 MitraClip, visit . For U.S. important safety information on the Amplatzer Piccolo Occluder, visit . For U.S. important safety information on Navitor, visit . About the Abbott TRILUMINATE Pivotal Trial The TRILUMINATE pivotal trial is the world's first randomized, controlled clinical trial evaluating the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy in people with symptomatic severe TR who are at intermediate or greater risk for open-heart surgery. Data presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in October 2023 for all randomized patients (N=572) and those enrolled in the concurrent single-arm group (patients with more complex tricuspid valve anatomy) illustrated the device's safety, effectiveness and benefits. 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

CEO Bill Hunter said Canary’s move into heart disease from knees, hips and shoulders isn’t necessarily a major departure for the company. Canary Medical, the former Fierce 15-winning developer of smart orthopedic implants, is stretching its wings—with plans to move beyond bones and joints and into connected cardiovascular devices. The company announced it has completed an early, first-in-human trial of a sensor-equipped cardiac implant that can listen to the sounds of a beating heart for the bubbling of a leaky valve or signs of other conditions.  Canary also wants the device—which it described as the first implantable acoustic monitor of its kind—to help track the effectiveness of medications among patients suffering from congestive heart failure. According to the company, the limited study included two patients in Paraguay and was able to record and identify the sounds that signal mitral valve regurgitation. The results will also help establish the sensor’s sensitivity and specificity, as well as the final design of its microphone system. In a recent interview with Fierce Medtech, CEO Bill Hunter said Canary’s move into heart disease from knees, hips and shoulders isn’t necessarily a major departure for the company. “My whole technical team, we're all cardiovascular folks—actually, we ended up accidentally in orthopedics,” said Hunter, an M.D. whose work in previous companies focused on heart disease devices and treatments. “Only now, we have the toys so that we can do something about it.” And as the company continues to build out its cloud-connected digital platform and early warning features, he said that both fields of medicine can benefit from taking the same approaches to data-driven prevention. “I really feel like we’re right on the tipping point of something significant,” he said. “I'll meet with a lot of docs, and justifiably they'll say to me, ‘I've been doing this for 25 years, and my patients are happy. I don't really know what these devices add to it.’”  “And we’ll say, here's the situation: We know for a fact that 50% of patients are lost to follow-up… and those patients might not come back until they’re already in bad shape. If we can identify those people, then pick up the phone and say, 'Hey, I'm a little worried about what you're doing'—the patients love that, right? It's good care.” Canary launched its smart knee add-on, Canturio, in 2021 through a partnership with Zimmer Biomet; the sensor slots into the implant to help monitor a patient’s gait and joint performance following a replacement procedure. Meanwhile, the company’s Persona IQ data platform helps automatically log metrics such as range of motion, step count and walking speed. Hunter also said that Canary hopes to build out its monitoring platform to help smarten up a wide range of medical implants in the future. “I always get in trouble for saying this because it sounds kind of flippant, but when you live in a world where your refrigerator is connected to the internet—I mean, we’re talking about life-saving medical devices that cost thousands and thousands,” Hunter said. “And when an implant goes wrong, it's going to be a $100,000 mistake.” “If it gets infected, or if there are complications—that and rescue surgery are just terrible for the patient,” he added. “So it seems inconceivable to me that we don't do everything we can to get some sort of feedback from the device.” “We put it in and then what do we do? We do X-rays and MRIs to try and figure out what's going on. But we never bother to put something in it in the first place. So I would be shocked if we're sitting here 10 years from now and most medical devices don't have some sort of connectivity.”

The Cardiac Auscultation monitoring device was trialed for use with heart failure patients as an adjunct to care in monitoring the effectiveness of congestive heart failure medication management The limited clinical trial represents the first human implantation of a cardiac auscultation sensor device Heart failure affects one in five people, with half dying within five years of diagnosis VANCOUVER, British Columbia, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Canary Medical, a medical data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem, today announced the completion of the first-in-human limited feasibility trial of their Cardiac Auscultation (Acoustic) monitoring sensor device. The device is being developed as a first-in-class implantable sensor to provide daily adjunctive objective cardiac parameter measurements enabling patients and clinicians to better manage their congestive heart failure symptoms with current medication management tools. This trial, conducted in Paraguay, represents the first successful human implantation of a cardiac auscultation sensor device. The first-in-man trial was designed to ascertain the sensitivity, specificity and final design specifications of the device’s microphone system. The trial was completed successfully on two patients and demonstrated mitral regurgitation sound signals are visible by the sensor when compared to normal acoustic heart signals. “Today Canary Medical announced the first step in expanding our sensor technology applications outside of orthopedics. The Cardiac Auscultation monitor is just one of the exciting new products that will drive the future growth of our Company,” said Bill Hunter, M.D., Founding Member and Chief Executive Officer of Canary Medical. “Congratulations to our world-class research and development team and thank you to the individuals who were the first to receive this new technology. While these are early results, we believe that the future is bright for patients who will benefit from Canary’s expanded sensor portfolio in the years to come.” The U.S. heart failure market is projected to be $70B annually by 2030. One in five people will develop heart failure in their lifetime with half of patients dying within five years of their diagnosis. About Canary Medical Canary Medical is a medical data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem. In 2021, Canary Medical introduced canturio™te, the world’s first “smart knee” tibial extension, which is implanted in the body where it monitors patient activity and joint performance, and transmits data to the cloud, autonomously, requiring almost no patient compliance or physician involvement. The Company was conceived and created with the vision that healthcare transformation requires reliable and cost-effective healthcare data and that the effective monitoring and analysis of that data will produce better outcomes for patients at lower costs. Canary Medical is led by a team of experienced entrepreneurs, researchers and data scientists globally regarded for their expertise in medical device design, development and data informatics. For more information contact us at admin@canarymedical.com or visit www.canarymedical.com. Follow Canary Medical on Twitter at @CanaryMedical. Investor Contact Monica KendrickCanary MedicalSenior Vice President, Communicationsmkendrick@canarymedical.com Media ContactsJonathan PappasLifeSci Communicationsjpappas@lifescicomms.como: (857) 205-4403 Products presented herein are research and development concepts that may be developed into medical devices for US Food and Drug Administration commercial market application review and subsequent commercial use. These representations are forward looking research design concepts and have not entered development and are not commercially available. Legal Disclaimers Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the successful completion of research and development, completion of clinical trials, marketing of the products described above, acceptance of such products by the medical community, regulatory approvals, and numerous other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Canary does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will canary be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages. The information contained in this presentation, including the accompanying oral commentary, is provided solely for the purpose of acquainting you, as its recipient, with Canary Medical and its subsidiaries (the “Company”, “we”, “us” or “our”) and its executive personnel. 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