Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)…
FDA Approves Second Generation Heart Valve From Edwards Lifesciences
June 16, 2014 by Leave a Comment
The next phase of the burgeoning and rapidly maturing transcatheter aortic valve replacement (TAVR) market has begun. Edwards Lifesciences announced on Monday afternoon that the FDA had approved its second generation Sapien XT TAVR device for the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis (AS). … Click here to read the full post on Forbes. …
Medtronic’s CoreValve Gains New Indication For High Risk Patients
June 12, 2014 by Leave a Comment
Medtronic’s CoreValve system today gained a second indication from the FDA for use in patients with severe aortic stenosis who are at high risk for surgery. … Click here to read the full post on Forbes. …
Medtronic To Pay Over $1Billion To Settle Patent Litigation With Edwards Lifesciences
May 20, 2014 by Leave a Comment
After years of protracted and often bitter litigation in the US and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves. Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022. … Click here to read the full post on Forbes. …
New Medtronic Heart Valve Threatened By Court Decision
April 15, 2014 by Leave a Comment
A legal injunction may severely limit the availability in the United States of Medtronic’s CoreValve device, which only received FDA approval earlier this year. The device received abundant praise recently when a large clinical trial demonstrated substantial advantages for CoreValve over traditional open-heart surgery. The injunction is the latest episode in an ongoing patent war in which Edwards Lifesciences, which pioneered…
First TAVR Comparison Trial Favors Sapien XT Over CoreValve
March 30, 2014 by Leave a Comment
With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards…
Survival Advantage for TAVR Over Surgery in High-Risk Patients
March 29, 2014 by Leave a Comment
Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery. Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published…
FDA Grants Earlier Than Expected Approval For Medtronic’s CoreValve
January 17, 2014 by Leave a Comment
The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. … Click here to read the full post on Forbes….
Pivotal Results For Medtronic’s CoreValve
October 29, 2013 by Leave a Comment
Key data on what will likely be the second transcatheter aortic valve to gain approval in the US were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the Trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open heart…
Medtronic Faces Removal Of CoreValve Transcatheter Heart Valve From German Market
July 12, 2013 by Leave a Comment
In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany. Medtronic said it would appeal…
FDA Issues Warning Letter To CoreValve Investigator
February 28, 2013 by Leave a Comment
The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…
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