News

Sapien XT, FDA

The U.S. Food and Drug Administration (FDA) approval for its Edwards Sapien XT transcatheter aortic heart valve for the treatment of high-risk and inoperable patients suffering from severe...

Watchman, LAA occluder

Interventional thought leaders at the American College of Cardiology (ACC) 2014 meeting shared their predictions about the cutting-edge technologies emerging today that will become commonplace in...

June 16, 2014 — PolyNova, a startup company that has grown out of an inter-institutional collaboration between the University of Arizona (UA) and Stony Brook University, announced it is developing...

June 16, 2014 — Boston Scientific Corp. has initiated the RESPOND post-market registry to assess real-world performance of the Lotus valve system. The RESPOND registry will collect data on...

Medtronic announced it is purchasing Covidien in a cash-and-stock deal for $42.9 billion. Once the transaction is completed, Medtronic will have significantly advanced its position as a premier...

Medtronic 3f Enable Aortic Bioprosthesis Valve Repair Cardiovascular Surgery

Medtronic Inc. announced five-year follow-up data demonstrating the safety and performance of the Medtronic 3f Enable Aortic Bioprosthesis — the world's first commercially available sutureless...

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...