Search Results for: watchman

Early Watchman Experience Reassuring, But Many Questions Remain

In the year and a half after its approval the Watchman left atrial appendage closure device was successfully implanted 95.6% of the time, or more than 3,600 times out of a total of 3,822 consecutive cases. The finding comes from procedural data collected by Boston Scientific and presented at TCT by Vivek Reddy (Mt. Sinai)…

Click here to continue reading…

CMS Proposal Would Plug Up Watchman Reimbursement

Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…

Click here to continue reading…

What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific

Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…

Click here to continue reading…

Yet Another Delay For Boston Scientific’s Watchman Device

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…

Click here to continue reading…

Encouraging 4 Year Results For Watchman Device In AF Patients

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…

Click here to continue reading…

FDA: Watchman device will need to wait a bit longer

The FDA is requiring Atritech to perform another study to confirm the safety and efficacy of the Watchman left atrial appendage closure device before it can receive full approval. Atritech said it will work closely with the FDA on the study design and that it hopes to start the study later this year….

Click here to continue reading…

WATCHMAN: will it replace warfarin in some patients? (updated)

Updated with commentary from David Kandzari– The WATCHMAN percutaneous left atrial apendage closure device is as effective as warfarin in reducing the risk of stroke in patients with non-valvular AF, but use of warfarin is not likely to go away anytime soon, according to the publication of the PROTECT AF trial in the Lancet and…

Click here to continue reading…

FDA panel gives cautious nod to the Watchman

The FDA’s Circulatory System Devices Panel voted 7-5 in favor of the Watchman, an implantable device that blocks the left atrial appendage with a fabric-covered expandable nitinol cage. It is designed to help patients with nonvalvular AF avoid warfarin therapy. You can read a Heartwire story, a MedPage story, or a Reuters story. You can…

Click here to continue reading…

FDA: is it time for the Watchman?

Following its promising debut in the PROTECT-AF trial a few weeks ago at the ACC, the Watchman device appears likely to receive a somewhat less ecstatic response when it appears before the FDA’s Circulatory System Devices Panel on Thursday. The Watchman is an implantable device that blocks the left atrial appendage with a fabric-covered expandable…

Click here to continue reading…

CABANA: No Outcomes Benefit In First Big Trial Of AF Ablation

(Updated) Catheter ablation for atrial fibrillation (AF) produced no significant improvement in clinical outcomes in a large and important new clinical trial. CABANA is the first and long anticipated randomized controlled trial of AF ablation in the more than two decade long history of the procedure. The results will likely spark an intense controversy in…

Click here to continue reading…

Cardiology Is Dead. Long Live Public Health.

Cardiology is dead. Here’s two new important pieces of evidence: The FDA’s Cardiovascular and Renal Drugs Advisory Committee hasn’t met since April 2015, and even then it was for the decidedly uninspiring drug cangrelor. And the committee has no meetings scheduled for the rest of this year. Take a look at the list of late-breaking…

Click here to continue reading…

New Stroke Prevention Device May Not Prevent Strokes

–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…

Click here to continue reading…

Cardiac Devices Could Become a Big Problem For Califf And The FDA

–Approvals with no strong evidence of efficacy: What could go wrong?  The FDA has a big problem. It likes to approve new drugs and devices. Approvals look good politically and allow the FDA to boast each year about their large number of approvals. But when the FDA approves a drug or device that doesn’t work…

Click here to continue reading…

The Impact Of ABSORB II: Down The Slippery Slope

When it was approved earlier this year in July the Absorb (Abbott) bioresorbable stent provoked a fair amount of discussion about the “slippery slope of noninferiority.” Although the stent met the FDA criteria for approval, the available trial results went in the wrong direction and there was a particularly concerning warning sign of a higher…

Click here to continue reading…

No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize

Let’s start with a quick poll:  Which is worse? A. The pervasive influence of industry on medicine, which has undermined the independence and altruism of physicians. B. The critics of industry influence, who have created a paranoid culture of distrust which has undermined the partnership of industry and physicians that has brought medicine to its current heights. If you chose B then you are…

Click here to continue reading…

FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device

The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. … Click here…

Click here to continue reading…

Novel Boston Scientific Device Headed For Another Rough FDA Panel

On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel.  The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than…

Click here to continue reading…

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

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…

Click here to continue reading…

Boston Scientific May Face A Tough FDA Panel

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…

Click here to continue reading…

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

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…

Click here to continue reading…

ACC Prevails Upon Boston Scientific To Present More Data At Late Breaker

In an unusual reversal of a statement it made two days ago, Boston Scientific announced this afternoon that it would present all three co-primary endpoints of the PREVAIL clinical trial this Saturday at the American College of Cardiology scientific sessions in San Francisco. The PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage…

Click here to continue reading…

Late-Breaking News: Confusion Over ACC Late-Breaker Trial

In an extremely unusual move, only days before the scheduled presentation of the main results of a highly-anticipated late-breaking clinical trial, the trial’s sponsor announced that the full results of the trial would not be presented. Instead, the company said the principal investigator would present only one of three of the trial’s primary endpoints, the acute procedural…

Click here to continue reading…

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

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…

Click here to continue reading…

Subcutaneous ICD Gains FDA Approval

The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and  therefore  does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage…

Click here to continue reading…

PROTECT AF: new device may offer alternative to warfarin for AF patients

A new implantable device may help patients with nonvalvular AF avoid warfarin therapy, according to results of the Embolic Protection in Patients with Atrial Fibrillation (PROTECT AF) trial. The trial was presented today in Orlando at the ACC Scientific Sessions. The new device, called the Watchman, blocks the left atrial appendage with a fabric-covered expandable…

Click here to continue reading…