InnovHeart Announces First-In-Human Implantation of Saturn TMVR System and 30-Day Results
September 24, 2020–InnovHeart s.r.l. announced the successful first-in-human implantation of the company’s Saturn transcatheter mitral valve replacement (TMVR) system, which demonstrated excellent results in the first patient at 30-day follow-up.
VitalConnect Begins TELESTAR-TAVR Study of Remote Patient Monitoring System
September 16, 2020—VitalConnect, Inc. announced that it has begun the TELESTAR-TAVR clinical study that is evaluating the company’s VistaSolution Live technology to monitor patients after undergoing transcatheter aortic valve replacement (TAVR).
Medtronic Begins Early Feasibility Study of Intrepid System to Treat Tricuspid Valve Regurgitation
September 9, 2020—Medtronic announced FDA approval of an early feasibility study of the Intrepid transcatheter tricuspid valve replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation.
POPular TAVI Study Compares Antithrombotic Strategies After Valve Replacement
August 30, 2020—Findings from the POPular TAVI trial challenge current guideline recommendations on antiplatelet treatment after transcatheter aortic valve replacement (TAVR) in patients not taking oral anticoagulation, according to the European Society of Cardiology (ESC).
CardioMech AS Announces Series A Financing for its Transcatheter Mitral Valve Repair Technology
August 5, 2020—CardioMech AS announced it has closed on its Series A financing to support the process of a first-in-human feasibility trial for the company’s catheter-based transfemoral, transseptally delivered mitral valve repair technology to reduce or eliminate mitral regurgitation.
Keystone Heart Launches TriGuard 3 Cerebral Embolic Protection Device in Europe
July 29, 2020—Keystone Heart, Ltd., a Venus Medtech company, announced the completion of the first commercial case using the TriGuard 3 cerebral embolic protection (CEP) device, which is designed to minimize the risk of cerebral damage during transcatheter heart procedures.
Valve-in-Valve TAVR Compared With Redo SAVR in Study in France
July 27, 2020—In Journal of the American College of Cardiology (JACC), Pierre Deharo, MD, et al published findings from a study that analyzed the outcomes of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) at a nationwide level in France (2020;76:489-499).
Edwards and Abbott Settle Global Transcatheter Litigation
July 13, 2020—Edwards Lifesciences Corporation and Abbott separately announced that they have reached an agreement to settle all outstanding patent disputes between the companies in cases related to transcatheter mitral and tricuspid repair products.
Ten-Year Follow-Up Reported From a Single-Center Experience With Early TAVR Devices
July 6, 2020—Investigators assessed the clinical outcomes, rate of structural valve deterioration (SVD), and bioprosthetic valve failure (BVF) in patients after transcatheter aortic valve replacement (TAVR) to 10‐year follow‐up in patients treated at St.
CMS Proposes to Expand Coverage for Transcatheter Edge-to-Edge Repair for Functional MR
June 30, 2020—The Centers for Medicare & Medicaid Services (CMS) announced the proposed update for its national coverage policy for the transcatheter edge-to-edge repair (TEER) procedure of the mitral valve to include patients with functional mitral regurgitation (MR).
Abbott Announces New Data for its Structural Heart Device Portfolio
June 25, 2020—Abbott announced the presentation of late-breaking data at the virtual PCR e-Course held online June 25 to 27, including studies of its transcatheter devices for the treatment of mitral regurgitation (MR) and tricuspid regurgitation (TR).
Medtronic Evolut TAVR System Receives Approval for Low-Risk Indication in Europe
June 22, 2020—Medtronic announced CE Mark approval and the European launch of the Evolut system for transcatheter aortic valve replacement (TAVR) in patients with severe native aortic stenosis who are at a low risk of surgical mortality.
Early Results Published From Real-World Experience With Pascal System for Transcatheter Edge-to-Edge Mitral Valve Repair
June 11, 2020—Online in EuroIntervention, Christian Besler, MD, et al published early results from a real-world series evaluating transcatheter edge-to-edge mitral valve repair with the Pascal system (Edwards Lifesciences).
Patient Selection and Periprocedural Imaging for Transcatheter Tricuspid Valve Interventions
A discussion of how and when various imaging modalities should be used during transcatheter tricuspid valve intervention and the anatomic and clinical characteristics that help guide patient selection.
By Karl-Patrik Kresoja, MD, and Philipp Lurz, MD, PhD
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in Europe.