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HANGZHOU, China and CAESAREA, Israel and TAMPA, Fla., /PRNewswire/ -- Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, today announced it has closed its Merger with Keystone Heart Ltd., a privately-held medical device company and makers of TriGUARD 3™. The Merger provides Venus Medtech with TriGUARD 3, the first Cerebral Embolic Protection Device designed to provide complete coverage to all brain regions for patients undergoing cardiac procedures, as well as an established clinical and commercial organization in both the US and Europe.
"It is of utmost importance to us that our devices improve the quality life of the patients whom receive them," said Eric Zi, co-founder and CEO of Venus Medtech. "Our transcatheter heart valve systems offer patients life-saving support – acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and Europe through which we can introduce our entire portfolio of products. We will be the first to bring the significant and extensive benefits of combining embolic protection devices together with our Venus TAVR products for Chinese's patients"
Keystone Heart is focused on protecting the brain from embolic debris to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other structural heart procedures. The company is currently enrolling patients in the REFLECT trial in the US to evaluate TriGUARD 3, anticipating enrollment completion in the early part of the first quarter of 2019 and FDA approval in Q3 of 2019. CE mark approval for Europe is anticipated by the end of Q1 2019.
"We are excited to be joining a truly entrepreneurial company like Venus," said Chris Richardson, president and CEO, Keystone Heart, LTD. "Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies – underscoring its dedication to excellence, determination to provide a total solution for patients undergoing TAVR procedures and focus on patient safety. This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the US & Europe."
About Venus Medtech (Hangzhou) Inc.
Venus Medtech (Hangzhou) Inc. is a leading heart valve developer in China. TAVR, which is also referred to as transcatheter aortic valve implantation (TAVI), is a minimally invasive surgical procedure conducted to repair a damaged aortic valve. A damaged aortic valve obstructs blood flow from the heart into the aorta and onward to the rest of the body, and if left untreated, may lead to death. There will be approximately 160,000 TAVR procedures conducted this year worldwide. Venus's transcatheter aortic valve was the first CFDA (China Food and Drug Administration) approved technology. Its transcatheter pulmonic valves are currently completing clinical trials. They are also developing the next-generation structural heart technologies designed for increased safety, long term durability and healthcare economics. Venus Medtech's goal is to be a worldwide transcatheter heart valve company. For more information visit: www.venusmedtech.com.
About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral embolic protection devices intended to reduce the risk of brain embolization associated with cardiovascular procedures. The company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other cardiovascular procedures. During these cardiovascular procedures, debris from the aortic valve, ascending aorta and other sources may embolize and cause cerebral infarction. Embolic brain lesions resulting from these procedures may lead to potentially devastating outcomes — stroke, dementia and cognitive decline. Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect the patient's processing speed, executive function, and fundamental skills such as memory, language, and balance.i These lesions may be related to changes in the way your brain functions or processes information, and lesions in the brain stem can impact basic body functions such as breathing, swallowing, heart rate, blood pressure, consciousness, and whether one is awake or fatigued.ii The location of these lesions determines the damage and clinical symptoms, and where a lesion may occur is unpredictable. The TriGUARD 3 product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons preserve brain reserve while performing these procedures. Headquartered in Israel with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The company's management has extensive experience in the fields of interventional cardiology and medical devices. For additional information, please contact us or visit: www.keystoneheart.com.
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SOURCE Keystone Heart Ltd.
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