News

June 3, 2014 — Edwards Lifesciences Corp. received CE mark for the advanced Edwards Intuity Elite valve system. The next-generation, rapid deployment system facilitates smaller incisions in...

June 3, 2014 — JenaValve Technology Inc., a privately held, venture-backed developer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, announced...

Direct Flow Medical has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate the pivotal phase of the SALUS trial. The SALUS trial...

CardiAQ Valve Technologies announced it successfully implanted its second-generation transcatheter mitral valve (TMVI) using the company’s newly added transapical delivery system. The transapical...

Boston Scientific REPRISE II Clinical Trial Six-month Results Lotus Valve

Further validating its advanced transcatheter aortic valve implantation (TAVI) technology, the Boston Scientific Corp. Lotus Valve System continued to demonstrate impressive performance at six...

Direct Flow Medical Transcatheter Aortic Valve 12-month Outcomes

Direct Flow Medical Inc. announced 12-month outcomes from the DISCOVER CE mark clinical trial.

St. Jude Medical Portico TAVR System U.S. Implants Clinical Study

St. Jude Medical Inc. announced that the first patient implants occurred in the Portico Re-sheathable Transcatheter Aortic Valve System U.S. IDE Trial (PORTICO trial).

Transcatheter Technologies Gmbh Trinity TAVI Heart Valve Repair EuroPCR 2014

Transcatheter Technologies GmbH, an emerging medical device company that is developing a third-generation transcatheter aortic valve implantation (TAVI) system — Trinity) — announced that its...

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

In a surprise move, Edwards Lifesciences Corp. and Medtronic reached an agreement this week to settle all outstanding patent litigation between the companies, including cases related to...

For the first time, a minimally invasive transcatheter valve — tested by Baylor Research Institute in Dallas (BRI) — has been shown to save more lives than open-heart surgery, according to new...

May 8, 2014 — Abbott announced its catheter-based MitraClip therapy has received Health Canada approval, providing physicians in Canada with the treatment option that can significantly...

May 2, 2014 — Medtronic Inc. revealed new data demonstrating positive outcomes for extreme risk patients with severe aortic stenosis who were treated with the CoreValve system via alternative...

April 28, 2014 — JenaValve Technology Inc. – a privately held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems – announced it has...

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

The Federal Circuit Court of Appeals granted a request from Medtronic Inc. to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System...

Tendyne Holdings Inc. has secured $25 million in an oversubscribed Series C financing led by Apple Tree Partners, along with Boulle Group members and other existing investors. 

Corevalve beats surgery, ACC 2014, TAVR vs surgery, Edwards lawsuit

The U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR) system in the United...

 Mitralign Inc. has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR).

April 7, 2014 — A first-ever randomized head-to-head comparison of two devices commonly used to treat aortic stenosis finds balloon-expandable transcatheter valves (such as the Edwards Sapien)...

Corevalve beats surgery, ACC 2014, TAVR vs surgery

The key trial presented at the 2014 American College of Cardiology (ACC) that will likely be the one attendees will remember “they were there for” in the years to come was data showing...

April 1, 2014 — Medtronic Inc. announced the one-year results of the Melody transcatheter pulmonary valve (TPV) U.S. post-approval study, which found that real-world use of the Melody TPV was...