The idea of implanting a device in the heart to block blood flow may sound counterintuitive, but for left atrial appendage devices such as Boston Scientific’s Watchman FLX, intentional blocking is It can save lives.
Watchman devices are designed to be used in patients with atrial fibrillation that are not due to heart valve problems, instead of long-term use of anticoagulants such as warfarin.
The cylindrical device is implanted in the opening of the left atrial appendage, a small pouch in the muscle wall of the upper left chamber of the heart. Scientists are not yet convinced of the exact functioning of the appendages, but in patients with atrial fibrillation, blood collects in the pouch to form a clot, which is pumped out of the heart for stroke and systemic embolism. It can cause illness.
By blocking the openings in the appendages, Watchman FLX prevents the formation of those blood clots. Newly published clinical trial data show that, in fact, only 3.4% of patients using Watchman devices experienced ischemic stroke or systemic embolism two years after transplantation.
This is well below the secondary efficacy endpoint of studies that the Watchman system considered successful when the two-year stroke and embolism incidence reached 8.7%.
Two-year data found that none of the 400 US patients studied in the study experienced device embolization or pericardial effusion after device implantation.
Watchman FLX announces new results for Pinnacle FLX Trial Approved According to the FDA for use to reduce the risk of stroke in patients with atrial fibrillation who need an alternative to long-term oral anticoagulant therapy.
Initial research result Presented earlier this year at the American College of Cardiology’s annual science session, Watchman FLX has achieved all of its major safety and efficacy endpoints in flight color.
In the safety category, only 2 out of 400 patients (corresponding to 0.5% of the group) experienced adverse events within 7 days of the procedure. On the other hand, this device has been shown to successfully block blood flow to the left atrial appendage in 100% of patients and maintain that blockage 45 days and 1 year after transplantation.
At the time, researchers also noted that implants resulted in a stroke rate that was about 77% lower than the average for high-risk patients with atrial fibrillation.
In summary, the Pinnacle FLX test results are “extremely encouraging” for the core audience of the device. It mainly consists of elderly patients with complex heart disease who are at high risk of stroke when taking oral anticoagulants. according to To Saibal Kar, the co-principal researcher of the research.
With the thorough proven safety and effectiveness of Watchman FLX, Boston Scientific will shift its focus to several other ongoing studies on the device.
One of these, an optional trial, compares the performance of the device with the performance of oral anticoagulants in patients with atrial fibrillation who have also undergone cardiac ablation. Another patient, named Champion-AF, will study the ability of the device to prevent embolic stroke in a larger patient population.
https://www.fiercebiotech.com/medtech/boston-scientific-heart-implant-linked-to-steep-drop-off-stroke-risk-for-afib-patients Boston Scientific Cardiac Implants Associated with Rapidly Reduced AFib-Related Stroke Risk: Study