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WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use

WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use

WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use

NATICK, Mass., Aug. 26, 2012 /PRNewswire/ — European regulators have approved an expanded indication for the Boston Scientific Corporation (NYSE: BSX) WATCHMAN® Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants, a new treatment option for stroke reduction.

Atrial fibrillation affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients in AF have an increased risk of stroke due to the migration of clots formed in the LAA. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients.

This CE Mark approval of the WATCHMAN device was based on results from the ASAP study. WATCHMAN is a novel device introduced into the heart via a flexible tube (catheter) through a vein in the groin intended to close off the LAA. The device is designed to capture any clots that may form in the appendage, reducing the risk of stroke and potentially eliminating the need for long term use of blood thinning medications.

“The expanded indication for WATCHMAN represents a significant advance for these patients who are at high risk of stroke, but who are unable to take conventional anticoagulant therapy,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “WATCHMAN continues to demonstrate that it is an effective therapy for preventing stroke in patients with atrial fibrillation.”

In addition, the European Society of Cardiology (ESC) today announced the inclusion of LAA closure devices in the revised “Guidelines for Management of Patients with Atrial Fibrillation.” The recommendation was based on the expansive WATCHMAN LAA closure device clinical data, collected on more than 2,000 patients and exceeded the equivalent of 4,000 patient years of follow up across multiple studies. These studies include the PROTECT AF trial, which proved the WATCHMAN device was non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy; the ASA Plavix (ASAP) Registry, which demonstrated a 77 percent reduction for ischemic stroke in patients contraindicated to warfarin; and the Continued Access PROTECT AF trial, which demonstrated improved procedural outcomes with experience.

The WATCHMAN device was approved for use in Europe in 2005 and some countries in Asia in 2009. Boston Scientific recently completed enrollment in the PREVAIL study, a confirmatory study designed to gain U.S. Food and Drug Administration approval. Patient follow up for the study is six months. In the U.S., the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Atritech, which Boston Scientific acquired in March 2011. Please visit http://www.bostonscientific.com/watchman-eu for more information.

For more news about Boston Scientific please follow us on Twitter @bsc_eu_heart (https://twitter.com/BSC_EU_Heart).

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.

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We have more info on the Watchman, the mesh stent we covered last year, which is being studied for its ability to prevent blood clots in patients with atrial fibrillation. See, if you’ve got atrial fibrillation, you carry about a 2-3% annual chance of developing a stroke from these clots (above the matched baseline risk). To manage this risk, most patients get coumadin, an anticoagulant that’s unfortunately difficult to dose, and comes with a hefty risk of hemorrhage.

If the Watchman works, many patients could be spared the hassle, unpredictability, and risk of coumadin. There’s a nice article in the North Country Times about the state of Watchman research:

The Watchman blocks off the left atrial appendage so it’s no longer part of the circulatory system, Buchbinder said. In a matter of weeks, the sievelike cloth mesh is covered by living cells, which grow together, walling off the left atrial appendage. This changes the pattern of blood flow, reducing the likelihood that a blood clot will form. The Watchman does not treat atrial fibrillation itself, which must be handled separately.

So, what does that left atrial appendage do, anyway?

Closing off an area of the heart sounds drastic, but all the evidence indicates the left atrial appendage isn’t needed, Buchbinder said.

Buchbinder said closing it off doesn’t cause any disability to the patient because the appendage isn’t known to have any real function.

“It’s a vestigial, residual organ, and nobody really knows why it is there,” Buchbinder said. “It has no particular clear-cut function. It is a residue from when we were embryos.”

There’s a theory that the appendage senses the water concentration in blood, causing us to be thirsty when there’s too little water. However, Buchbinder said, all the medical evidence to date shows that people get along perfectly well without it, such as when it’s closed off during heart surgery.

Patients with atrial fibrillation (AF) are at an increased risk of stroke that can originate in the left atrial appendage (LAA), an evolutionary holdover that most think has no purpose. The inlet does create a space where a thrombus can form and lead to an ischemic stroke. Anticoagulants like warfarin are typically the desired approach, but patients carry substantial risk of internal bleeding, either spontaneously or with minor trauma.

The WATCHMAN device from Boston Scientific was developed to fill the space of the LAA and capture any clots that form within. Now the company received expanded indication approval in Europe to offer this treatment to AF patients that have a contraindication to the currently available anticoagulants. Take a look at our flashbacks below for our previous coverage of the WATCHMAN over the last six years as it’s been progressing through the clinical trials.

Additionally, the announcement reports acceptance of LAA closure devices for AF treatment by the European Society of Cardiology:

In addition, the European Society of Cardiology (ESC) today announced the inclusion of LAA closure devices in the revised “Guidelines for Management of Patients with Atrial Fibrillation.” The recommendation was based on the expansive WATCHMAN LAA closure device clinical data, collected on more than 2,000 patients and exceeded the equivalent of 4,000 patient years of follow up across multiple studies. These studies include the PROTECT AF trial, which proved the WATCHMAN device was non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy; the ASA Plavix (ASAP) Registry, which demonstrated a 77 percent reduction for ischemic stroke in patients contraindicated to warfarin; and the Continued Access PROTECT AF trial, which demonstrated improved procedural outcomes with experience.

Source : http://bostonscientific.mediaroom.com/

www.2012-08-26-Boston-Scientific-WATCHMAN-Left-Atrial-Appendage-Closure-Device-Receives-CE-Mark-Approval-For-Expanded-Use

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