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Abbott secures CE mark for dual-chamber leadless pacemaker
Abbott recently announced that it has received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system. The Aveir DR is the world’s first dual-chamber leadless pacemaker, designed to treat individuals with abnormal or slow heart rhythms. It enables wireless, beat-to-beat communication between two leadless pacemakers, with one pacing the right ventricle (Aveir VR) and the other pacing the right atrium (Aveir AR). Each device is approximately one-tenth the size of a traditional pacemaker, making them smaller than a AAA battery. This system delivers electrical impulses directly to the heart muscle, restoring normal heart rhythm. Unlike traditional pacemakers, these leadless devices are inserted directly into the heart via a minimally invasive, catheter-based procedure, eliminating the need for cardiac leads and a subcutaneous pulse generator. Using Abbott’s proprietary i2i (implant-to-implant) technology, the system provides synchronized pacing on every heartbeat according to the patient’s clinical needs. The i2i technology utilizes high-frequency pulses to transmit messages through the body's blood, taking advantage of its naturally conductive properties, and requiring less battery power than inductive, radiofrequency, or Bluetooth communication. In July 2023, Abbott announced it had received FDA approval for the dual-chamber pacemaker system, and the company completed the first U.S. commercial cases with Aveir DR in November.
Siemens Healthineers Unveils New Cardiology Applications for Acuson Sequoia…
Siemens Healthineers has recently announced new cardiology applications enhanced with artificial intelligence for the Acuson Sequoia ultrasound system, along with a new 4D transesophageal (TEE) transducer for cardiology exams. These advancements establish the Acuson Sequoia as a comprehensive ultrasound system suitable for regional hospitals as well as radiology and vascular clinics operating under a shared service model. This model utilizes a single ultrasound system for radiology, obstetrics/gynecology, and cardiology exams, eliminating the need for both a general imaging system and a dedicated cardiology system. “Siemens Healthineers is committed to pioneering ultrasound technology that transforms clinical care and improves patient outcomes,” said Daniel Frisch, global head of Radiology Ultrasound at Siemens Healthineers. “Adding these cardiology applications with artificial intelligence-powered features and our new 4D TEE transducer to the Acuson Sequoia will benefit clinicians who need the highest level of performance in nearly every clinical scenario.” The new AI-powered cardiology features include AI Measure, which automates the detailed measurements required for routine echocardiography exams, a task traditionally time-consuming and labor-intensive. AI Measure can perform up to 120 AI-powered calculations, significantly reducing the time needed for routine echo exams. The 2D HeartAI feature leverages AI to enhance exam efficiency and workflow during cardiac strain imaging, which measures myocardial deformation. It offers auto view detection and auto contour placement with or without an electrocardiogram, and simplifies the diagnostic processes for ejection fraction evaluation and cardiac strain analysis, thus reducing unnecessary follow-up exams. Additionally, new software enables clinicians to generate wall motion scoring reports for stress echo exams. These scores help assess cardiac function under various stress levels, aiding in presurgical cardiac evaluations and minimizing unnecessary follow-up exams. The new Z6T 4D TEE transducer supports biplane imaging, allowing clinicians to view multiple scan planes simultaneously for quicker and potentially more accurate diagnoses. This transducer is designed for preoperative assessments and provides interventional guidance for advanced cardiac procedures requiring high volume rates to assess moving structures and high resolution for evaluating cardiac anatomy. Furthermore, the redesigned 5V1 transthoracic transducer (TTE) addresses the challenges of imaging patients with a high body mass index. It supports comprehensive echocardiograms, enabling the detection and diagnosis of cardiac dysfunction or abnormal pathology by physicians and sonographers.
Atraverse Medical Secures FDA Approval for Left-Heart Access Device,…
Atraverse Medical announced that its Hotwire radiofrequency guidewire left-heart access device has received clearance from the FDA. This innovative device facilitates zero exchange left-heart access while serving as a guide for catheter-based therapy systems. Conceived by Steven Mickelsen, co-founder of Farapulse, and Eric Sauter, the Hotwire system marks another success for Mickelsen, following the recent treatment of the first patients by his company, Field Medical, in pulsed-field ablation. Atraverse Medical's device boasts universal sheath compatibility and optimized radiofrequency (RF) technology, with the aim of enhancing outcomes and streamlining procedural workflows. “The FDA clearance of the Hotwire underscores our dedication to medical innovation and our commitment to improving the standard of care for procedures requiring transseptal access including endocardial ablation, left atrial appendage closure, and mitral valve repair,” Mickelsen said in a news release. Dr. Devi Nair, director of cardiac electrophysiology and research at St. Bernard’s Medical Center, praised the system for its potential to revolutionize left-heart therapies, noting its ability to accommodate physicians' preferred transseptal access workflows, which could lead to safer and more efficient procedures. In addition to achieving regulatory approval, Atraverse has successfully closed an oversubscribed seed funding round, raising $12.5 million. Investors include physicians, venture capitalists, and leaders in the medical technology sector. The company intends to utilize these funds to accelerate research and development efforts and advance early commercialization initiatives. “We are thrilled to have achieved FDA clearance in less than two years since founding the company, and the completion of our seed round positions Atraverse Medical for continued success in transforming the landscape of left-heart access,” said John Slump, co-founder, president and CEO.
Medtronic’s renal denervation system receives approval in China
Medtronic has revealed that its Symplicity Spyral renal denervation system has secured approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Symplicity Spyral becomes the inaugural renal denervation (RDN) system for treating high blood pressure to gain approval from China's NMPA. The company has outlined plans to navigate the provincial registration process and anticipates initial sales of the RDN system in China to be conservative. The approval follows Medtronic's FDA approval for Symplicity Spyral about six months earlier, making it the second company in the U.S. to obtain premarket approval for an RDN system. Additionally, in March of this year, the system received licensing from Health Canada. “As the leader in renal denervation, we are looking forward to bringing the Symplicity blood pressure procedure to China, where high blood pressure rates continue to increase,” Jason Weidman, SVP and president of the Coronary and Renal Denervation business within Medtronic’s Cardiovascular Portfolio, said in a news release. “As these rates continue to climb, the need for innovative, alternative treatments is strong. The Symplicity procedure can provide people in China with another potential option when seeking high blood pressure solutions, complementing lifestyle modifications and medication.”

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