Boston Scientific Recalls and Discontinues Lotus Edge Aortic Valve System
November 17, 2020—Boston Scientific Corporation announced it has initiated a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system because of complexities associated with the product delivery system.
Effectiveness of Rivaroxaban Compared to Warfarin in RIVER Trial
November 14, 2020—The primary results from the RIVER trial of rivaroxaban for valvular heart disease and atrial fibrillation show that rivaroxaban is comparable to warfarin, which is currently the standard of care anticoagulant prescribed for patients with bioprosthetic mitral valves.
Survey of Heart Valve Patients Shows Need for Increased Awareness About Clinical Trial Enrollment
November 5, 2020—Most heart valve patients are not very aware of clinical trials, but most patients would consider enrolling in a clinical trial, according to results of a nationwide survey announced by HeartValveSurgery.com, an advocacy group for patients with heart valve disease.
MITHRAS Evaluates Interventional Closure of Residual Atrial Septal Defect After TMVR
October 15, 2020—The MITHRAS randomized clinical trial found that interventional closure of an iatrogenic atrial septal defect (iASD) driven by transcatheter mitral valve repair (TMVR) was not superior to conservative medical treatment with regard to the primary endpoint of change in 6-minute walking distance.
REFLECT II Trial Evaluates Keystone Heart's TriGuard 3 Cerebral Deflection Filter for TAVR
October 15, 2020—The REFLECT II randomized clinical trial evaluating the safety and efficacy of the TriGuard 3 self-stabilizing cerebral embolic deflection filter (Keystone Heart, Ltd., a Venus Medtech company) found that the device met the primary safety endpoint compared to historical controls but did not demonstrate superiority of the device for the primary hierarchical efficacy endpoint.
Symetis Acurate Neo TAVR Device Fails to Show Noninferiority in SCOPE II Trial
October 15, 2020—In the randomized SCOPE II clinical trial, a new self-expanding bioprosthetic valve used in transcatheter aortic valve replacement (TAVR) failed to demonstrate noninferiority compared to an existing self-expanding valve.
Randomized SMART Trial Will Evaluate Medtronic’s Evolut Pro and Pro+ TAVR Systems in Small Annulus Patients
October 14, 2020—Medtronic announced it will begin two studies, the SMART postmarket trial and EXPAND TAVR I feasibility study, of its Evolut transcatheter aortic valve replacement (TAVR) technology.
Medtronic Partners With The Foundry to Develop Mitral Valve Repair Technology
October 14, 2020—Medtronic announced a partnership with The Foundry, a medical device company incubator based in Menlo Park, California, to invest in and create a company with the goal of developing a transcatheter mitral repair (TMVR) technology.
Cardiac Dimensions Receives Financing to Accelerate Commercialization of Carillon System in Europe and Australia
September 29, 2020—Cardiac Dimensions announced the company has closed a $17.5 million Series C financing to support the commercialization of the company’s Carillon mitral contour system to treat functional mitral regurgitation (FMR) in patients with heart failure.
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.
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.