Renal denervation is back. Or not. The failure of renal denervation (RDN) was one of the most spectacular failures in cardiovascular medicine in recent years. Great expectations for RDN appeared to die with the Simplicity-3 HTN trial, the first rigorous test of the technology, which showed that it was ineffective in the treatment of resistant…
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…
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…
Three Trials Show Benefits Of Thrombectomy In Stroke Patients
February 11, 2015 by Leave a Comment
Three new studies offer important additional evidence that early treatment with current thrombectomy devices that extract clots from blood vessels in the brain can lead to improved outcomes in carefully selected stroke patients. The trials were stopped early based on efficacy following positive findings last year from another trial, MR CLEAN. The three new trials were…
FDA Approves New Medtronic Drug-Coated Balloon To Open Blocked Leg Arteries
January 5, 2015 by Leave a Comment
Medtronic said today that it had received approval from the FDA to market its In.Pact Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the upper leg. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. … Click here to read the full post on Forbes. …
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. …
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…
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…
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…
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…
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…
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…
Stents Lose In Comparisons With Surgery And Medical Therapy
December 3, 2013 by Leave a Comment
Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive…
Prolonged Dual Antiplatelet Therapy May Not Be Necessary For Second-Generation Drug-Eluting Stents
October 31, 2013 by Leave a Comment
The precise duration of dual antiplatelet therapy (DAPT) following implantation of a drug-eluting stent (DES) has been the subject of considerable controversy. On the one hand, prolonged therapy may help prevent late stent thrombosis, which was particularly evident in first generation DESs. On the other hand, the risk of stent thrombosis may have diminished in…
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…
FDA Approves First New Atherectomy Device In 20 Years
October 22, 2013 by Leave a Comment
The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said it would begin a controlled launch of the…
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…
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…
BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block
April 24, 2013 by Leave a Comment
Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may…
Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns
March 27, 2013 by Leave a Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. Case Report Of Durata Lead Failure Raises Fresh Concerns by Edward J. Schloss, MD A case report of a failed St. Jude Medical Durata…
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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