–Preliminary results from SPYRAL HTN-Off Med BARCELONA – Renal denervation is back from the dead, but only as a faint shadow of its former self. Initial interim results of the SPYRAL HTN-Off Med study suggest that the new and improved version of renal denervation (RDN) produces a real but very modest reduction in blood pressure….
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
March 14, 2017 by 3 Comments
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…
Interventional Cardiology And The Rejection Of Science
July 22, 2016 by 6 Comments
–Prominent interventional cardiologist says clinical trials are slowing progress In their eagerness to embrace a glorious future of ever more spectacular technology-based advances, interventional cardiology— a subspecialty never exactly known for caution, patience, or self reflection— is poised to reject science, evidence-based medicine, and randomized controlled trials. “Generating and publishing evidence is a tedious job,”…
Study Shows Why Sham Controls Are Necessary For Device Trials
January 12, 2016 by 1 Comment
— If we can melt the ice-caps then surely we can understand our own fallibility, says one UK cardiologist. The strongest known force in the universe is the ability of the human mind to deceive itself. If we know something to be true then we find the evidence to prove it. There is no better…
Califf, Nissen, And Others Agree And Disagree About Regulatory Standards
September 1, 2015 by 1 Comment
Everyone agrees. A panel of US and European cardiologists, regulators, and industry executives agreed broadly that regulatory standards for drugs and devices need to be rigorous enough to prevent harm to patients. And, they also agreed, the standards shouldn’t be so strict that they stifle innovation. The problem, of course, is how to find the right…
Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year
February 19, 2015 by Leave a Comment
Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their…
New Device to Lower Resistant High Blood Pressure Shows Early Promise
January 22, 2015 by 1 Comment
A novel implantable device appears to show early promise in the treatment of resistant hypertension. The “Coupler” device from privatelyheld ROX Medical is about the size of a paper clip and is delivered via a catheter to the upper thigh, where it creates a connection between the vein and the artery, which lowers blood pressure in the arteries by…
2014 Dubious Innovations In Cardiology
December 23, 2014 by Leave a Comment
Dubious Innovative Device: Renal Denervation Dubious Innovative Business Strategy: Health Diagnostics Laboratory Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine Dubious Innovative Breakthrough Therapy That Never Actually Breaks Through Anything (repeat winner): Cardiac Stem Cell Therapy Click here to read the full post on Forbes. …
The Walking Dead: Renal Denervation In Europe Just Can’t Be Stopped
May 21, 2014 by Leave a Comment
Earlier this year the only large, well-designed trial of renal denervation– the once highly-promising catheter-based technology that was widely expected to “cure” difficult cases of resistant hypertension– failed spectacularly. Many hypertension experts believe that ultimately the technique will prove to be beneficial, but after the failure of Simplicity HTN-3 it is clear that there’s a great deal…
The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure
April 14, 2014 by Leave a Comment
Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt. Although the device has not been approved in the US– and will not be approved without…
No Benefit Found in First Real Test of Renal Denervation
March 29, 2014 by Leave a Comment
SYMPLICITY HTN-3, the eagerly awaited first rigorous test of renal denervation, shows that the real effect of the novel blood-pressure-lowering technology is dramatically lower than earlier expectations, which had been fueled by data from previous uncontrolled trials. Results of SYMPLICITY HTN-3 were presented at the American College of Cardiology conference 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. …
Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong
February 20, 2014 by Leave a Comment
In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering…
Pivotal Medtronic Trial For ‘Breakthrough’ Blood Pressure Device Goes Down The Tubes
January 9, 2014 by Leave a Comment
The hypertension community woke up this morning to a large dose of reality with an announcement by Medtronic that the novel SYMPLICITY HTN-3 trial of its much-anticipated renal denervation device had failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm…
Realistic Expectations For New ‘Breakthrough’ Blood Pressure Technology
September 10, 2013 by Leave a Comment
Early trials of renal denervation, the innovative new catheter-based blood pressure lowering technology, have resulted in extremely impressive drops in systolic blood pressure in the range of 30 mm Hg. These results have sparked a great deal of excitement in the hypertension community and stirred the interest of a multitude of medical device companies. Some…
St. Jude Raises The Stakes In Renal Denervation With An Outcomes Study
February 15, 2013 by Leave a Comment
The already hot field of renal denervation for resistant hypertension just got a little hotter. With the announcement of a clinical trial powered to detect improvements in cardiovascular outcomes, St. Jude Medical has raised the stakes. … “To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in…
Renal Denervation: Delineating Its Uses, Misuses, and Possibilities
January 22, 2013 by Leave a Comment
Over on CardioExchange, Murray Essler, the chief investigator of the Symplicity HTN-2 trial, answers questions from John Ryan about renal denervation: Non-pharmacologic antihypertensive measures must remain the starting point for patients with hypertension, but will often not be enough. Renal denervation should be reserved for patients in whom behavior modification combined with adequate and skillful antihypertensive…
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