–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
For Scott Gottlieb, Business Trumps Health
March 14, 2017 by Leave a Comment
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
Encouraging Results Found In Long Term TAVR Registry
November 30, 2015 by Leave a Comment
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)…
New Concerns Raised About Bioprosthetic Aortic Valves
October 5, 2015 by Leave a Comment
New, potentially important concerns have been raised about bioprosthetic aortic valves, both those implanted during surgery and those during a catheter-based procedure (TAVR). Investigators from three separate groups reported on their troubling findings in a paper published in the New England Journal of Medicine. The article was accompanied by both an editorial and a perspective from the FDA….
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…
High Risks And Rewards Found With Heart Valve Device From Edwards And Medtronic
March 10, 2015 by Leave a Comment
Transcatheter aortic valve replacement (TAVR) is one of the most important advances in cardiovascular medicine in recent years. TAVR devices, introduced recently in the US by Edwards Lifesciences and Medtronic, are associated with very high risks, but offer a less invasive alternative to traditional aortic valve replacement surgery. Because of early concerns about potential overuse and misuse of…
Aortic Valve Surgery for Nonagenarians
October 30, 2014 by Leave a Comment
As people continue to live longer physicians are increasingly confronted with very elderly patients who have serious conditions that might benefit from surgery but who are at high risk for surgical complications. In a paper published in the Annals of Thoracic Surgery, doctors at the Mayo Clinic reviewed their experience with 59 patients age 90 or older who…
Study Explores Expanded Use For Edwards’ And Medtronic’s New Heart Valves
July 8, 2014 by Leave a Comment
In the last few years transcatheter aortic valve replacements from Edwards Lifesciences and Medtronic have entered the marketplace and now offer an alternative to surgery for some patients. Now these valves are being considered for use in patients who have already undergone surgery but whose bioprosthetic valves have failed. Although surgeons and patients increasingly prefer…
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. …
Will Edwards Snatch Defeat From The Jaws Of Its Victory Over Medtronic?
April 21, 2014 by Leave a Comment
On the heels of a sweeping victory in the courts over its rival Medtronic, Edwards Lifesciences is poised to dominate the TAVR (transcatheter aortic valve replacement) market– the revolutionary new catheter technology that offers some patients with life-threatening aortic valve disease an alternative to chest-splitting surgery. Although the legal wrangling is not quite over– Medtronic is appealing the decision and has requested…
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…
What To Expect At The American College of Cardiology Meeting
March 24, 2014 by Leave a Comment
The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly-anticipated late-breaking clinical trials. On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation…. … Click here to read the entire post on Forbes. …
French Surgeons Perform First Aortic Valve Surgery Without Opening The Chest
March 11, 2014 by Leave a Comment
Surgeons in France report that they have performed the first total endoscopic aortic valve replacement (TEAVR) in 2 human patients. Their paper has been published in the the Journal of Thoracic and Cardiovascular Surgery [subscription required]. … The new procedure may enable surgeons to replace the aortic valve without opening the chest, though it will still require cardiopulmonary…
Heart Societies Issue New Guidelines For Valve Disease
March 3, 2014 by Leave a Comment
The American Heart Association and the American College of Cardiology today released new practice guidelines [PDF] for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as…
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…
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…
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…
2012 In Review: A Bad Year For Conventional Wisdom
December 24, 2012 by 3 Comments
This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…
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…
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