Shares of Cytori Therapeutics took a big bit hit today after the company disclosed in a press release that it had suspended enrollment in its ATHENA and ATHENA II trials. This kind of news is never a good sign, but the principal investigator of the trial tells me that he believes the current problems are surmountable and that the trials are still…
Principal Investigator Of Suspended Cytori Stem Cell Trials Remains Hopeful
August 6, 2014 by Leave a Comment
Clot Busters For Stroke Gain More Support
August 6, 2014 by Leave a Comment
Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects on patients treated after 3 hours, on older patients, and on patients with mild and with severe strokes. Now a new metaanalysis published in the Lancet offers evidence that the use of thrombolysis should be more…
Study Finds Flaws in New Treatment For Blood Clots
July 22, 2014 by Leave a Comment
In recent years, catheter-directed thrombolysis (CDT) has been added to the current standard of anticoagulation therapy in some patients with deep vein thrombosis (DVT). The hope was that CDT would help reduce the high rate of post-thrombotic syndrome (PTS), but now an observational study finds no benefits and some important disadvantages associated with CDT. In a…
FDA Places Clinical Hold On Phase 3 Trial Of Novel Anticoagulant
July 10, 2014 by Leave a Comment
A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect. REGULATE-PCI is a phase 3…
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…
ESC Hot Lines: First Real Data On Promising Novartis Heart Failure Drug
July 1, 2014 by Leave a Comment
The first real details about the much-anticipated novel new heart failure drug from Novartis will kick off this year’s Hot Line sessions at the annual meeting of the European Society of Cardiology in Barcelona, Spain. The meeting runs from August 30 until September 3. As I have previously reported, the PARADIGM-HF trial was stopped because of a highly statistically significant reduction…
Study Offers Reassurance About Newer Drug-Eluting Stents
July 1, 2014 by Leave a Comment
Drug-eluting stents (DES) have been viewed as a great advance over earlier stents and balloon angioplasty because they result in many fewer cases of restenosis. But enthusiasm for the first generation of DES was somewhat curbed due to reports of late stent thrombosis (ST), a rare but very dangerous complication. Now findings from a large ongoing…
Yet Another Delay For Boston Scientific’s Watchman Device
June 17, 2014 by Leave a Comment
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said…
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. …
Wide Range In Cancer Risk From Radiation In Children Undergoing Heart Surgery
June 9, 2014 by Leave a Comment
Children with heart disease are at increased risk for developing cancer later in life due to their exposure to radiation during imaging procedures. Since an ever-growing number of children with heart disease now reach adulthood, this may become an increasingly important public health issue. A new study published in Circulation offers some reassurance in finding that for most…
Prescription Delay Following Stent Implantation Is a Common and Deadly Problem
May 28, 2014 by Leave a Comment
After receiving a stent, many patients delay or fail to fill their prescription for clopidogrel or another antiplatelet agent. Now, a study published in the Journal of the American Heart Association offers evidence that this problem is widespread and often leads to serious consequences. Researchers analyzed data from all stent implantations performed in British Columbia from 2004 through…
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. …
New Study Lends Support For Alternative Heart Attack Treatment Strategy
April 22, 2014 by 2 Comments
It is generally agreed that the best treatment for heart attack patients is to immediately reperfuse the blocked artery with a stent. But many people live in areas where this strategy, known as primary PCI, is not available within the time frame when it produces the greatest benefit. Previous studies have found good short term…
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…
Aspirin and Clonidine Fail to Help Surgery Patients
March 31, 2014 by Leave a Comment
Heart attacks (myocardial infarctions) are among the most common and serious side effects of noncardiac surgery. An effective regimen to minimize this risk has been the subject of considerable debate in recent years. The controversy was recently exacerbated because the recommendation to use beta-blockers in this setting was based on research which has now been…
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…
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. …
US Patients More Likely Than English Patients To Receive Life-Saving Surgery
March 13, 2014 by Leave a Comment
Patients with a ruptured abdominal aortic aneurysm (rAAA)– a very serious life-threatening illness that occurs more often in elderly men– have better outcomes in the United States than in England, according to a new study published in the Lancet. Researchers at the University of London compared hospital data from 11,799 rAAA patients in England with 23,838 rAAA…
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