Watchman: Promising New Device for Heart Problem, But not Without Risks
March 29, 2009
(ChattahBox)—Results of a new clinical study came out this week, testing a new device, dubbed the Watchman, which shows promise for treating atrial fibrillation, a common heart malfunction, suffered by more than more than two million men and women in the United States. Researchers hope this device can replace current drug therapies using blood thinners, such as coumadin and warfarin, which can have dangerous side affects, with prolonged use. Dr. David Holmes Jr. of the Mayo Clinic in Rochester, Minn. led the study, which was paid for by the Watchman’s maker, Atritech Inc. of Plymouth, Minn.
The results of the clinical trials showed that the Watchman device performed slightly better than drug therapies, with a bit over three percent of patients fitted with the device experiencing strokes, heart-related deaths and blood clots, compared to five percent of patients using the blood thinner drug, warfarin.
However, some patients using the device suffered complications, such as strokes, from the procedure to insert it, showing the device is not without risk. Patients using warfarin can develop side affects from the drug over time. Scientists say, if the device garners FDA approval, patients suffering from atrial fibrillation will have to decide if they want to risk side affects right away with the implantation of the device, or risk developing complications after years of taking blood thinners.
During the study, Dr Holmes studied 707 patients with atrial fibrillation, showing 15 strokes and 17 deaths in the 463 patients who were implanted with the device, compared to 11 strokes and 15 deaths in the 244 patients treated with warfarin alone.
The doctors believes the complications from the device will lessen over time, as doctors become more experienced with inserting it and learn from the results of the study. Atrial fibrillation sufferers who experience hazardous side affects from the blood thinner drugs, requiring frequent blood work to monitor the dangers, are hopeful all the kinks will be worked out of this new device, providing them with another treatment option.
Atritech Inc is expected to seek FDA approval for the device soon, potentially giving millions of sufferers of atrial fibrillation relief from hazardous drug therapies.