New Heart Device for ‘No-Option’ Chest Pain Patients Shows Early Potential
VahatiCor’s A‑Flux Reducer System, a self‑expanding, recapturable coronary sinus device, was implanted in a first‑in‑human cohort of 12 patients with coronary microvascular dysfunction or obstructive CAD. Eleven procedures were completed without any device‑related complications, and patients experienced significant improvements in angina class and Seattle Angina Questionnaire scores that persisted for six months. The study, published in JSCAI, highlights the device’s safety profile and its potential as a therapeutic option for “no‑option” chest‑pain patients. Ongoing trials aim to assess longer‑term outcomes.
Whole-Body MRI Provider Starts Offering AI-Powered CCTA Scans
TrueScan, a whole‑body MRI center in St. Peterburg, Florida, has begun offering AI‑powered coronary CT angiography (CCTA) from Heartflow, available as a standalone test or bundled with its MRI packages. The move addresses growing patient and physician demand for coronary imaging...
3D Software Helps Cardiologists Plan Ahead for TAVR Complications
Sentara’s high‑volume TAVR center adopted the AI‑enabled DASI 3‑D planning platform to move beyond static CT measurements. The software dynamically simulates valve frame expansion, calcium deformation, and tissue interaction, allowing clinicians to test multiple valve sizes and depths before the...
PFO Closure After Thromboembolism Linked to Strong 20-Year Outcomes
A new 20‑year follow‑up of 130 patients who received transcatheter patent foramen ovale (PFO) closure after a paradoxical embolism shows sustained safety and efficacy. The cohort, with a mean age of 46, experienced a recurrent stroke rate of 0.04 per...
FDA Shares New Warning About Johnson & Johnson Heart Pumps After 4 Injuries
The FDA issued an early‑alert notice on February 3, 2026, highlighting a leak risk in Generation 1 purge cassettes used with Johnson & Johnson MedTech’s Impella RP heart‑pump sets. A leak can trigger a low‑pressure alarm, potentially causing biomaterial ingress, pump stoppage, and loss...
ASE Promoting 3D Echo as a Better Way to Treat Congenital Heart Disease
The American Society of Echocardiography (ASE) is championing 3‑dimensional echocardiography as the preferred tool for diagnosing and guiding treatment of congenital heart disease. ASE is standardizing image display and terminology to align imagers, interventional cardiologists, and surgeons, and will deliver...
FDA Approves New Biotronik Pacing Lead for LBBAP
Biotronik received FDA clearance for its Solia CSP S pacing lead, a device engineered specifically for left bundle branch area pacing (LBBAP). The lead combines a stylet‑driven platform with a novel fixed‑helix screw, addressing procedural simplicity and electrical performance. Approval relied on...
Heart Failure Company BioVentrix Files for IPO
BioVentrix, a Massachusetts medtech firm developing the Revivent heart‑failure system, filed an IPO prospectus on Feb. 12, targeting a Nasdaq listing under BVXX. The company estimates a $10 billion valuation in the U.S. and $16 billion globally. Revivent, a minimally invasive LV reconstruction...
Gore Completes Acquisition of Medtech Company Behind Next-Gen Heart Device
W. L. Gore & Associates has completed its acquisition of Conformal Medical, the developer of the investigational CLAAS AcuFORM left atrial appendage occlusion system. The deal, announced in January, makes Conformal a wholly‑owned Gore subsidiary while keeping its focus on the foam‑based...
Medtronic’s RDN System Receives New Reimbursement Approval
Medtronic’s Symplicity Spyral renal denervation system has secured reimbursement approval from Japan’s Ministry of Health, Labour and Welfare, expanding coverage for resistant hypertension. The therapy, which uses radio‑frequency energy to ablate renal nerves via a single catheter, was previously approved...
AI-Powered MRI Evaluations Predict STEMI Outcomes Better than Existing Risk Scores
A machine‑learning model that combines cardiac MRI data with clinical variables predicts long‑term major adverse cardiovascular events (MACE) in STEMI patients more accurately than the GRACE and TIMI scores. The study analyzed 1,066 patients, training on 682 cases and testing...
TAVR Linked to Higher Reintervention Rate than SAVR in Evolut Low Risk Trial Update
A six‑year update of the Medtronic‑funded Evolut Low Risk trial shows that transcatheter aortic valve replacement (TAVR) with a self‑expanding valve has a higher reintervention rate than surgical aortic valve replacement (SAVR) in low‑risk patients—5.5% versus 3.3% at six years,...
FDA Clears 12-Lead, Cable-Free Home ECG Monitoring System
The FDA granted 510(k) clearance for HeartBeam’s cable‑free 12‑lead ECG synthesis software, allowing home‑based arrhythmia assessment. The system captures cardiac signals in three non‑coplanar dimensions and reconstructs a full 12‑lead trace that can be reviewed by board‑certified cardiologists on demand....
CVRx Highlights Revenue Growth in Q4, Increased Momentum Going Forward
CVRx reported fourth‑quarter 2025 revenue of $16 million, a 4% year‑over‑year increase. Full‑year revenue rose 10% to $56.7 million, and the network of active implanting centers expanded to 252. The company secured Category 1 CPT codes for its Barostim device effective Jan 1 2026 and...
CCTA Becoming an Essential Tool for Interventional Cardiologists
Coronary computed tomography angiography (CCTA) is becoming a core tool for interventional cardiologists, enabling comprehensive pre‑procedure planning and reducing reliance on costly intravascular imaging. The addition of fractional flow reserve derived from CT (FFR‑CT) merges anatomical and physiological assessment, streamlining...
