News

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.

3-d pronting, 3D printing

The FDA has recognized 3-D printing technology now exists to print medical devices and is gathering information regarding technical assessments that should be considered when it will inevitably...

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...

American Heart Assn. Statement Babies Congenital Heart

Fetal heart experts working with the American Heart Assn. have developed guidelines to help healthcare providers care for unborn babies with heart problems, as well as their families.

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...

FDA MSC Consortium Stem Cell Research

The U.S. Food and Drug Administration (FDA) MSC Consortium is a large team of FDA scientists studying adult mesenchymal stem cells (MSCs), which could eventually be used to repair, replace,...

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 30, 2014 — Celladon Corp. announced its lead product candidate, Mydicar, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for reducing...

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...

April 23, 2014 — Xeltis announced it finished enrollment in a five-patient feasibility study of implantable products intended to enable for the first time the spontaneous growth of natural,...

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. 

Cytori Stem Cell Therapy Heart Failure Treatments PRECISE Trial

Cytori Therapeutics announced publication of safety and efficacy data from a 36 month European clinical trial of Cytori Cell Therapy in patients with chronic ischemic heart failure. 

April 18, 2014 — New research presented at the 34th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) demonstrated the CorMatrix particulate extracellular...