Yet Another Delay For Boston Scientific’s Watchman Device Reply

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 that it had been informed by the FDA that it will need to undergo yet another advisory panel before gaining approval.

Click here to read the full post on Forbes.

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The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure Reply

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 further clinical trials– in Europe and other places it remains on the market. So the questions about the technology’s future revolve around the future direction of research in the field and how the existing renal denervation market will be affected by the trial results.

Click here to read the full post on Forbes.

 

FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific Reply

The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the vote was 13-1.

Click here to read the full story on Forbes.

 

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Boston Scientific May Face A Tough FDA Panel Reply

On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response letter and earlier this year a scandal broke out when the American College of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial after the company broke an embargo by giving trial results to investors.

Wells Fargo analyst Lawrence Biegelsen predicts that the panel will be “contentious” but that ultimately the device will be approved next year. Although the trial missed one of its three c0-primary endpoints, the FDA reviewers emphasis on “the totality of the data” suggests a more benign FDA perspective, he writes.

One knowledgeable observer, Sanjay Kaul, who has served on several FDA panels, thinks the panel will indeed be contentious….

Click here to read the full post on Forbes.

 

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Stents Lose In Comparisons With Surgery And Medical Therapy Reply

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 and that some of the growth in PCI may have been unwarranted.

Click here to read the full post on Forbes.

 

New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs Reply

Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized incidents, have forced the FDA and ICD companies to initiate recalls. Now a prominent cardiologist writes that the S-ICD poses an “existential crisis” for previous generations of ICDs.

FDA approval of the S-ICD was based on a pivotal trial designed to assess the device’s safety and effectiveness. Results of the trial have now been published in Circulation. In this nonrandomized trial, the S-ICD was successfully implanted in 314 patients out of 321 in whom the implnantation was attempted.

The S-ICD easily met the prespecified primary safety and efficacy endpoints:

Click here to read the full post on Forbes.

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Encouraging 4 Year Results For Watchman Device In AF Patients Reply

Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation patients were presented yesterday at the Heart Rhythm Society meeting in Denver.

Previously, the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events in the trial was small. In addition, there were more safety problems, as might be expected, in the early days after implantation. The FDA required the company to perform a confirmatory trial. That trial, PREVAIL, has been the subject of considerable controversy. Now, long term followup of PROTECT AF may help better understand the risks and benefits of the device.

Vivek Reddy presented 4 year followup results from PROTECT AF. The primary efficacy endpoint– the combined rate of all stroke, cardiovascular or unexplained death and systemic embolism– occurred in  2.3% of the device group versus 3.8% of the warfarin group (RR 0.60, CI 0.41-1.05).

Click here to read the full story on Forbes.

 

 

 

The PREVAIL Fail Revisited: Spinning The Truth 1

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The biggest story at the American College of Cardiology meeting last week was the missing story. As reported here and just about everywhere else, the PREVAIL trial, probably the most-anticipated late-breaker of the meeting, was pulled from the program at the last minute by the ACC leadership after Boston Scientific broke the embargo by issuing a press release several hours before the scheduled presentation.

To understand this event we first need to know what happened in the week before the ACC. And there’s a major gap in the story that has not come out before that I think holds the key to a full understanding of the story.

More than a week before the scheduled presentation I received an email invitation from a PR firm representing Boston Scientific:

“If you have any interest in speaking about the trial under embargo with Dr. Ken Stein, chief medical officer, Cardiac Rhythm Management, Boston Scientific, I have a few slivers of availability early next week. As you know, the embargo lifts at the time of presentation and I’ll need written confirmation of your embargo agreement.”

Now I’ve been down this road before, as some of you may recall. Several years ago I was offered embargoed access to data from an important upcoming trial by Medtronic (suggesting that this is a systemic problem) under the condition that I agree to a briefing from a trial investigator. I told the company that I would respect the embargo but that I wanted to review the data on my own and that I would get back to them if I had any questions. Their response: no briefing, no data.

Here’s the problem in both cases: forcibly linking access to the trial data with a company-arranged briefing is an egregious perversion of the embargo system.

Click here to read the full post on Forbes.

 

Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC 2

UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that the scheduled presentation of the results at the main opening session of the meeting would not take place.

 

By way of background, last week the trial’s sponsor, Boston Scientific, first announced that the  principal investigator of the trial, David Holmes, would only “present the acute procedural safety results” from the trial. Then the company reversed itself two days later and announced that Holmes would present all three co-primary endpoints.

Holmes intended presentation this morning at the ACC in San Francisco makes clear why there was so much confusion. (The slides from his presentation have been made available to the media.) Although the trial results appear largely positive, the trial missed one of its three primary endpoints, and experts will likely spend a lot of time and energy trying to interpret the results.

Click here to read the full story on Forbes.

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Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program Reply

Two big trials will highlight this year’s American College of Cardiology meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific‘s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation. Second is  the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.

Read my complete story on Forbes, along with a list of the late-breakers. 

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