Release date: 2017-06-14 Recently, Claret Medical announced that the FDA has approved the company's Sentinel Brain Protection System (CPS) for sale in the United States according to the reclassification criteria. Sentinel is the first and only device available in the United States to provide protection against stroke risk by intercepting and removing debris that has fallen off during transcatheter aortic valve replacement (TAVR) before it reaches the brain. Sentinel As more and more heart valve repair procedures are converted from open surgery to transcatheter aortic valve repair (TAVR) surgery, TAVR surgery is a less damaging option for many physically weak patients. However, TAVR also faces certain risks during the operation. During the TAVR operation, the embolic fragments will be released. These fragments will pose serious risks to many tissues and organs, especially the brain. These fragments will block the blood vessels in the blood. If they are produced in the brain, it will cause Stroke. To address the shortcomings of TAVR surgery, Claret Medical developed the Sentinel Brain Protection System to optimize TAVR surgery. Sentinel composition Sentinel use Sentinel includes two filters that are delivered to the target location in a very wonderful way, one of which is the brachiocephalic artery and the other is the left common carotid artery. The device was inserted from the right arm right iliac artery and placed at the border of the brachiocephalic artery and the left common carotid artery. Dangerous debris will be trapped by the filter of the device, after which the captured debris will be removed from the right arm along with the device. Clinical evaluation Sentinel caused a 63% clinical stroke reduction in the first 72 hours after TAVR, plus the fact that one out of every four patients could collect an average of 25 visible debris, which was shocking. The device can be safely placed and the operation time is extended for a short period of time, which can prevent the embolic material and reduce the expected performance of ischemic brain damage. New Field Intrathoracic repair (TEVAR), left atrial appendage (LAAO) and transcatheter mitral valve repair and exchange. market Sentinel is the most well-studied device in the field of TAVR brain protection, and its development has been systematically evaluated in more than 1,000 patients in several studies, including three randomized controlled trials. To date, more than 3,500 patients have been protected worldwide, and it is the only commercially available brain protection system in Europe and some Asian countries, and is now included in the United States. Claret Medica Claret Medical is a privately held company founded in 2009 to develop innovative brain protection solutions for cardiac and vascular structural interventions. As of May 2017, a total of $26.48 million in financing was completed. Since 2011, the company has been a leader in brain protection and currently has a 97% market share in Europe. It is the first product in the category to be marketed in the United States. Source: MedTF Rice Transplanter,6 Rows Rice Transplanter,Walking Rice Transplanter,Efficient Manual Rice Transplanter Taizhou Yingtian Agricultural Machinery Manufacturing Co., Ltd. , https://www.sakuradaagc.com
The first and only FDA-approved embolic protection device Sentinel