Arterial Fibrillation – What will be the future standard of care, Warfarin or the Watchman Device?
Posted Mar 26 2009 3:53pm
Just as we are trying to get the genomic test in place for Warfarin, there’s a new device on the horizon. The device, called the Watchman is in clinical trials and the purposes of the device is to have an alternative option to having to take blood thinning medication, and this would be a person who is taking it on a life time treatment program, so not short term here.
Additional information can be found here from the website as relates to the study and it is under review at the FDA. Medical devices that we once thought were Sci-Fi are appearing on the horizon and in use today. The device is inserted via a catheter, like many of the endovascular procedures today, so the procedure is also minimally invasive. So far 110 individuals have the device in place in current studies. BD
How is the WATCHMAN implanted? (from the website)
Using standard techniques, similar to the ones used in commonly performed angioplasty procedures, your doctor will guide the WATCHMAN device into your heart through a flexible tube (catheter) inserted through a vein in your upper leg. Once the catheter is in the correct position, your doctor will take pictures of your heart in order to take appropriate measurements of your left atrial appendage. These measurements will determine which size WATCHMAN device to use. After the device is put into place, additional measurements and pictures will be taken to make sure the device is in the correct position. Once your doctor has confirmed the position, s/he will release the device to leave it permanently implanted in your heart.
With this procedure, you would need to stay in the hospital overnight and recovery will take about 24 hours.
MINNEAPOLIS, March 26 /PRNewswire/ -- Atritech, Inc. a clinical stage medical device company, announced today that it has completed a $30 million round of financing. Thomas, McNerney & Partners led the round along with a substantial investment from Split Rock Partners and insider investments from Prism Ventures, Tullis-Dickerson and Vector Group. Over the past 3 years, the Company has raised approximately $75 million in capital.
With this new funding, the Company will complete the Food and Drug Administration (FDA) review of the PROTECT AF clinical trial results along with the commercial launch of the WATCHMAN(R) LAA Closure Technology in Europe. The PROTECT AF clinical trial evaluates the WATCHMAN device versus the current standard of care, warfarin, in patients with atrial fibrillation.
In August of 2008, Atritech announced the filing of its Pre-Market Approval Application (PMA) to the FDA. The Company will present the PROTECT AF results to the FDA's Circulatory System Devices Panel on April 23, 2009. The WATCHMAN device continues to be implanted in a Continued Access Registry (CAP) while the product is under review at the FDA. To date over 110 devices have been implanted in CAP at approximately 20 sites in the U.S. and Europe.
Atritech's WATCHMAN device is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke. Patients with AF (a heart condition which causes the upper chambers of the heart to beat too rapidly) are at a greater risk of having a stroke. Typically these patients require blood thinning medications to prevent these clots from forming in the heart. Current medical therapy requires frequent monitoring and has diet and other drug interactions causing many patients to stop taking them. The WATCHMAN device may be an effective alternative for patients with AF who may not want to take blood thinning medications for life.