PROTECT H2H Directly Compares Stroke Protection Devices During TAVR 

April 12, 2026—The American College of Cardiology (ACC) announced that findings from the PROTECT H2H randomized trial were presented at the ACC.26 annual scientific session.

Innoventric’s Unica System to Treat Severe TR Granted FDA Breakthrough Device Designation

April 10, 2026—Innoventric, an Israel-based medical device company, announced that its Unica system for the treatment of severe tricuspid regurgitation (TR) has been granted FDA Breakthrough Device designation.

FDA Approves TRICURE US Pivotal Trial of TriCares’ Topaz TTVR System

April 9, 2026—TriCares SAS announced it has received investigational device exemption (IDE) approval from the FDA to conduct a pivotal clinical trial for its Topaz transcatheter tricuspid valve replacement (TTVR) system.

STAR Trial of TAVR With MiRus’ Siegel THV Begins Enrollment

April 9, 2026—MiRus, LLC, announced commencement of enrollment and the treatment of the first patients in the STAR trial of transcatheter aortic valve replacement with the company’s Siegel 8-F transcatheter heart valve (THV).

Egg Medical Launches EggNest Complete Flex for Apron-Free Radiation Protection

April 9, 2026—Egg Medical announced the launch of EggNest Complete Flex radiation protection, which enables clinicians to safely work apron-free or with ultralight lead aprons.

Philips’ DeviceGuide Cleared for Image Guidance in M-TEER With Edwards’ Pascal Ace System

April 7, 2026—Royal Philips announced it has received FDA 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an artificial intelligence (AI)–powered software solution that assists interventionists in transcatheter repair procedures of mitral regurgitation.

ALERT Study of Integrated EHR Platform Addresses Health Disparities in Structural Heart Disease Treatment

April 6, 2026—Medtronic announced data from the ALERT trial, which is designed to address health disparities and undertreatment in structural heart care using an integrated electronic health record (EHR) platform.

SURVIV Investigates Mitral Valve-in-Valve Procedure for Bioprosthetic Mitral Valve Dysfunction

April 3, 2026—Findings from the SURVIV trial showed that in patients with bioprosthetic mitral valve dysfunction, a transcatheter mitral valve-in-valve procedure (mVIV) to insert a new valve was associated with a lower rate of death or disabling stroke within 1 year, compared with patients who underwent standard redo mitral valve replacement surgery (rMVR).

Edwards Evoque TTVR System Evaluated in 2-Year Data From TRISCEND II Trial

April 3, 2026—Edwards Lifesciences announced that 2-year data from the TRISCEND II trial evaluating the company’s Evoque transcatheter tricuspid valve replacement (TTVR) system were presented at ACC.26, the American College of Cardiology’s annual scientific session.

JenaValve’s Trilogy THV System for Symptomatic, Severe AR Launched in the United States 

April 1, 2026—JenaValve Technology, Inc. announced the United States launch of the Trilogy transcatheter heart valve (THV) system.

PRO-TAVI: PCI Deferral Noninferior to PCI Before TAVR at 1 Year

April 1, 2026—Deferring percutaneous coronary intervention (PCI) until after transcatheter aortic valve replacement (TAVR) resulted in similar 1-year clinical outcomes compared with performing PCI before TAVR in older patients with severe aortic stenosis (AS) and coronary artery disease (CAD), according to results of the PRO-TAVI trial presented at ACC.26 and simultaneously published in The Lancet.

TRI-FR Trial Results Demonstrate T-TEER Lowers HF Hospitalizations at 2 Years

March 30, 2026—Transcatheter tricuspid edge-to-edge repair (T-TEER) combined with guideline-directed medical therapy reduced adverse clinical outcomes at 2 years compared with medical therapy alone in patients with severe, symptomatic tricuspid regurgitation, according to results from the TRI-FR trial presented at the American College of Cardiology’s Annual Scientific Session (ACC.26).

FDA Approves JenaValve’s Trilogy THV System for Symptomatic, Severe Aortic Regurgitation

March 18, 2026—JenaValve Technology, Inc., announced FDA premarket approval of the Trilogy transcatheter heart valve (THV) system for the treatment of patients with symptomatic, severe aortic regurgitation who are at high or greater risk for surgical aortic valve replacement.

Emboline Secures Funding for Commercialization of Emboliner Embolic Protection System

March 13, 2026—Emboline, Inc., announced it has closed $20 million in growth capital that will support preparations for the commercial introduction of the company’s Emboliner embolic protection system while continuing development of additional technologies designed to reduce embolic risk during structural heart interventions.

Mitria’s Subvalvular Spacer for Mitral Valve Repair Implanted in First Compassionate-Use Case 

March 6, 2026—Mitria Medical announced the first implantation of its subvalvular spacer (SVS) in the United States in a compassionate-use procedure under the FDA’s Single-Patient Expanded Access Program.

FDA Clears Cara Medical’s CTA-Based Platform for Cardiac Conduction System Visualization

February 27, 2026—Cara Medical Ltd. announced that the FDA has granted 510(k) clearance for the Cara system, a CTA-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.

AccurKardia’s AK-AVS AI-Enabled ECG Model Detects Aortic Stenosis Years Before TAVR

February 20, 2026—AccurKardia announced results from a new validation study showing that its artificial intelligence (AI)–enabled electrocardiogram (ECG) model, AK-AVS, can identify aortic stenosis (AS) years before patients undergo valve replacement and improve prediction of postprocedural outcomes, according to the company’s press release.

Salus Scientific AeroShield Radiation Protection Used in First Clinical Case

February 10, 2026—Salus Scientific and Tallahassee Memorial HealthCare (TMH) announced the first clinical use of AeroShield, a table-mounted, inflatable enhanced radiation protection device (ERPD), marking what the organizations described as the first deployment of the technology in a live catheterization laboratory setting.

Joint Commission Partners With STS and ACC in New Cardiac Care Certification

January 30, 2026—Joint Commission announced it has partnered with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) to leverage clinical performance data for a new cardiac care certification.

HighLife TMVR System Receives CE Mark Approval

January 26, 2026–HighLife SAS, a France-based developer of transcatheter solutions for structural heart disease, announced that it has received CE Mark approval for the HighLife transcatheter mitral valve replacement (TMVR) system.