News

Edwards Lifesciences Corp. announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW)...

JenaValve TAVI System Canada

JenaValve Technology Inc. has successfully completed the first two implantations of its second-generation transapical JenaValve transcatheter aortic valve implantation (TAVI) system in Canada....

Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility study is continuing, and early clinical results from the second implantation of the Colibri device confirm the...

Edwards Sapien 3 Transcatheter Aortic Hear Valve Clinical Trial

Edwards Lifesciences received conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards Sapien 3...

Thubrikar Aortic Valve’s Optimum TAV, transcatheter aortic valve implantation (TAVI) system, has surpassed 200 million cycles in an ongoing durability test — which simulates over five years in...

July 12, 2013 — A Chicago native living in southern California was the first patient at Scripps Health to receive a MitraClip as part of the clinical outcomes assessment of the MitraClip...

Researchers have announced the results of a clinical study that shows a key difference in the patient’s baseline heart size and function following transcatheter valve replacement (TAVR) that may...

FDA US device innovation

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies...

Valtech Cardio Heart Valve Repair Cardioband Annuloplasty Ring

Valtech Cardio Ltd. announced that two patients diagnosed with severe mitral regurgitation (MR) have been treated successfully with its Transfemoral Cardioband Annuloplasty System.

Abbott has announced publication of positive outcomes from two European post-approval studies of the catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results...

Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility...

June 3, 2013 — Medtronic Inc. announced it has received CE mark for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve implantation (TAVI) systems...

Cerebral function is the essence of quality of life. Its preservation throughout medical procedures is a key component to procedural success and patient care. New scientific data presented at the...

The Lotus Valve, a second-generation transcatheter aortic valve implantation (TAVI) device, was successfully implanted in all of the first 60 patients in results from REPRISE II, which showed good...

Direct Flow Medical Transcatheter Aortic Valve System 30 Day Outcomes

Direct Flow Medical Inc. said it met its primary endpoint in the fully-enrolled, 100-patient DISCOVER CE mark trial by achieving 99 percent freedom from all-cause mortality at 30 days. Patients...

Neovasc Inc. reported positive animal data from its Tiara program for the transcatheter treatment of mitral valve disease. Data presented is on long-term implantation of the Tiara mitral...

Sorin Group has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its Perceval S...

GE, TEE. amplatzer, 3D, 4D

The development of 3-D transesophageal echo (TEE) just a few years ago has enabled a new generation of interventional procedures to be performed, which otherwise would have been...

Live Transmission of TAVR Cases Safety SCAI 2013 Scientific Sessions

Live demonstration, transmission or recording of transcatheter aortic valve replacement (TAVR) has been found feasible and safe, even for the typically high-risk patients who undergo the procedure...

Simbionix ANGIO Mentor Structural Heart Simulator Models

Simbionix USA Corporation is proud to announce the release of various training modules for the ANGIO Mentor endovascular simulator.