News

Ventripoint Diagnostics is expanding subscription-based access to its FDA-cleared VMS+ 4.0 platform, which uses AI and Knowledge Based Reconstruction technology to generate MRI-comparable 3D volumetric measurements of all four cardiac chambers from standard echocardiographic images. The company is implementing a Device-as-a-Service model targeting approximately 80% subscription-based adoption to reduce capital budget barriers for hospital implementation.

Digest: This AI-powered echocardiographic platform addresses a critical need for accurate right ventricular volumetric assessment without requiring MRI, with subscription pricing potentially lowering adoption barriers for structural heart programs evaluating patients for interventions.

ASCEND Cardiovascular and Epsilon Imaging announced a strategic partnership integrating ASCEND's enterprise structured reporting platform with Epsilon's EchoInsight Zero Footprint advanced echo analysis system featuring speckle-tracking strain imaging. The integrated solution uses AI-based view classification and bidirectional data exchange to automate strain measurement workflow, generating over 100 standardized measurements based on ASE chamber quantification guidelines without manual data entry.

Digest: Automated strain imaging integration addresses a key workflow barrier to routine use of global longitudinal strain for cardiotoxicity monitoring, heart failure assessment, and valvular disease management in structural heart programs.

Abbott has initiated the Treat TR study, a post-market study enrolling approximately 1,000 patients across up to 100 sites in the U.S., Canada, and Europe to evaluate the safety and performance of the TriClip transcatheter edge-to-edge repair system for tricuspid regurgitation in real-world settings. Patients will be followed for five years, with a sub-study examining the system's potential to reverse cardiac remodeling.

Digest: This large-scale real-world evidence study will provide critical post-market performance data for TriClip TEER, informing adoption decisions and potentially expanding treatment paradigms for TR in clinical practice.

HOPPR launched its fifth AI foundation model, the EF Chest CT Narrative Model, which processes 3D chest CT volumes to generate narrative reports across pulmonary, mediastinal, cardiac, upper abdominal, osseous, and soft tissue regions. The model was trained on a large proprietary U.S. dataset with deliberate overrepresentation of serious conditions including aortic injury, pulmonary embolism, rib fractures, and pneumothorax.

Digest: This AI model offers potential automated assessment of cardiac and aortic anatomy on chest CT, which could support preprocedural planning and screening for structural heart interventions, though clinical validation data were not provided.

ElectroWire Medical received FDA 510(k) clearance for the LightningWire Transseptal Puncture System, a novel electrosurgical guidewire designed to create atrial septal defects for left-sided cardiac procedures. The 0.032-inch diameter system features proprietary insulation enabling low-power transseptal puncture while providing stiffness comparable to 0.035-inch guidewires, with compatibility across existing electrosurgical generators and transseptal introducers.

Digest: This device addresses a critical access step for multiple structural heart procedures including TMVR, LAAO, and atrial fibrillation ablation, potentially improving procedural efficiency and reducing costs through platform-agnostic compatibility.

University of Maryland researchers developed an AI-powered clinical support tool that analyzes electronic health records to identify undiagnosed pulmonary hypertension by automatically extracting and predicting missing mean pulmonary artery pressure measurements from right heart catheterization reports. The system was tested on 17,292 catheterization reports from over 11,000 patients treated between 2016-2024, addressing the clinical challenge that mPAP is missing in 7-33% of cases depending on the dataset.

Digest: This tool addresses a diagnostic gap in pulmonary hypertension detection that affects appropriate patient selection and hemodynamic assessment for structural heart interventions, particularly in evaluating patients for tricuspid and mitral valve procedures where pulmonary pressures are critical eligibility criteria.

University of Colorado Hospital's Heart and Vascular Center performs approximately 3,000 interventional and structural heart procedures annually, including complex PCI with hemodynamic support and transcatheter mitral valve repair. The program has participated in pivotal trials for structural heart devices and performs 25-50 chronic total occlusion procedures and 50 Impella-supported high-risk PCI cases per year.

Digest: This academic center's experience with MitraClip procedures, complex high-risk PCI, and participation in pivotal device trials provides insights into advanced structural heart program development and procedural volumes at high-performing institutions.