News

Boston Scientific, Safari2 pre-shaped guidewire, cath lab, TAVI, TAVR, FDA, CE

Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped Guidewire. Safari2 is an enhanced version of the  Safari Guidewire,...

Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA

Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in April to broaden its SALUS Trial. The expansion includes the...

GlobalData, TAVR, Edwards, Medtronic, CoreValve Evolut R, Sapien 3

The recent U.S. Food and Drug Administration (FDA) approvals of two next-generation transcatheter aortic valve replacements (TAVR) devices will transform the U.S. market for TAVR procedures over...

Biotronik, TAVI device, BIOVALVE trial, Hamburg, Germany

Biotronik announced the completion of the BIOVALVE first-in-human trial for its new transcatheter aortic valve. Study doctors successfully implanted the device in patients suffering from severe...

CardiAQ, Edwards, acquire, acquisition, Fortis, TMVI, mitral valve replacement

Edwards Lifesciences Corp. announced that it has agreed to acquire CardiAQ Valve Technologies Inc., a privately held company and developer of a transcatheter mitral valve replacement (TMVR) system...

CardiAQ Valve Technologies, TMVI, second generation, implantation, Tor Vergata

CardiAQ Valve Technologies (CardiAQ) announced that its second-generation transcatheter bioprosthetic mitral heart valve was successfully implanted as a compassionate treatment. The device...

REDUCE FMR, Cardiac Dimensions, Carillon Mitral Contour System, FMR

Cardiac Dimensions announced the first patients have been enrolled in the REDUCE FMR clinical trial. REDUCE FMR is a prospective, double-blind, randomized multi-center trial, evaluating the...

Medtronic, CoreValve Evolut R, FDA approval, TAVR, recapturable

Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the recapturable, self-expanding CoreValve Evolut R System. The first-and-only recapturable and...

Edwards, Sapien 3, FDA approval, transcatheter heart valve

Edwards Lifesciences Corp. announced U.S. Food and Drug Administration (FDA) approval of the Edwards Sapien 3 valve with the Commander Delivery System for the treatment of high-risk patients...

Portico, St. Jude Medical, FDA, U.S. evaluation, resume

St. Jude Medical Inc. announced the resumption of the company’s U.S. investigational device exemption (IDE) trial evaluating the Portico transcatheter aortic valve implantation system. The Portico...

MitraClip, ACC, TVT registry, STS, Betty Vaughn

Outcomes from the initial commercial experience of transcatheter mitral valve repair (TMVR) with Abbott’s MitraClip were deemed favorable in a late-breaking clinical trial session at the American...

Medtronic, CoreValve Evolut R, first clinical study, ACC.15

Medtronic plc announced initial clinical outcomes for its next-generation CoreValve Evolut R System at the 64th annual scientific session of the American College of Cardiology, March 14-16 in San...

Percutaneous Cardiovascular Solutions (PCS) announced it had been granted a key patent in the United States covering its percutaneous mitral valve replacement system.

Mitralign, six-month data, EuroPCR 2015, MPAS

Mitralign shared six-month data on its Mitralign Percutaneous Annuloplasty System (MPAS) for treatment of functional mitral regurgitation (FMR) at EuroPCR 2015 in Paris. The prospective, multi-...

Boston Scientific, Lotus, PVL, RESPOND, REPRISE II, EuroPCR 2015

A new study evaluating the Boston Scientific Lotus Valve System demonstrated an extremely low rate of paravalvular aortic regurgitation (leakage) for a transcatheter aortic replacement valve....

At EuroPCR 2015, Mitralign presented updates on its mitral and tricuspid valve repair systems, including a presentation on six-month data on its Mitral system.

Edwards, SAPIEN 3 trial, mortality, EuroPCR 2015

Edwards Lifesciences Corp. announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the SAPIEN 3 transcatheter aortic valve demonstrated very low mortality and...

Direct Flow Medical, Transcatheter Aortic Valve System, DISCOVER, EuroPCR

Direct Flow Medical Inc. announced positive two-year data from the DISCOVER CE Mark Trial studying its Direct Flow Medical Transcatheter Aortic Valve System at the EuroPCR conference in...

Edwards, Fortis, transcatheter mitral valve, trial, halts enrollment

Edwards Lifesciences announced it has temporarily halted its clinical trial of the Fortis mitral transcatheter heart valve. The company said that in consultation with trial investigators, it was...

CardiAQ, TMVI, FDA, IDE, feasibility study, mitral valve, Beth Israel Deaconess

CardiAQ Valve Technologies announced U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for a feasibility study of its second generation transfemoral (TF) and...