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)…
Encouraging Long Term Results For Less Invasive Heart Valves
March 15, 2015 by Leave a Comment
The publications five years ago of the two part PARTNER trial brought a major change in the treatment options available to some people with aortic valve disease, which is often an extremely serious condition with a poor prognosis. The trial demonstrated that transcatheter aortic valve replacement (TAVR) was a reasonable treatment option, first for patients who…
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…
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….
Edwards CEO Sold Stock 2 Weeks Before It Tanked
April 26, 2013 by 2 Comments
(Updated) Earlier this week the stock of Edwards Lifesciences tanked after the company announced weak Sapien sales and lowered its sales guidance for the rest of the year. The stock, which had been trading in the low 80s for the past month, dropped a heartbreaking 22% on Wednesday in response to the news and closed…
ACC And STS Break New Ground To Test TAVR For Unapproved Uses
February 12, 2013 by Leave a Comment
In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and…
TCT: Impressive Survival Benefit For TAVR In Inoperable Patients At 3 Years
October 24, 2012 by Leave a Comment
At the TCT meeting in Miami Murat Tuzcu presented the latest findings from the PARTNER B trial comparing transcatheter aortic valve replacement (TAVR) with standard therapy in patients who are not considered eligible for surgical valve replacement. At three years the mortality advantage continued to grow for TAVR over standard therapy in patients who are…
FDA Approves The Sapien Transcatheter Heart Valve For High Risk Patients
October 19, 2012 by 2 Comments
The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not…
The Name Game: Why Did “TAVI” Suddenly Become “TAVR”?
July 12, 2012 by 2 Comments
One of the great, unexplained mysteries of the cardiology world in recent years is the sudden name change from TAVI (transcatheter aortic valve implantation), which had been the universally-used name for the procedure during most of its development period, to TAVR (transcatheter aortic valve replacement) about the time when the procedure edged closer to US approval. Now,…
FDA Advisory Panel Recommends Expanded Indication For Sapien Transcatheter Heart Valve
June 14, 2012 by Leave a Comment
The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device…
Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve
June 13, 2012 by Leave a Comment
Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and…
FDA Reviewers Raise Questions About Sapien Heart Valve System
June 11, 2012 by 1 Comment
FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system…
Recent Comments