YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical™, a leading developer of advanced neurovascular devices, announced Chinese approval for its TIGERTRIEVER revascularization device. With this milestone of National Medical Product Administration (NMPA) approval, TIGERTRIEVER becomes the first device to offer patient-specific solutions for removing blood clots from the brain to advance the treatment of ischemic stroke. “This new approval for […]
Tag: China
Impulse Dynamics’ Optimizer® Receives CFDA Approval in China
ORANGEBURG, New York and STUTTGART, Germany, December 18, 2017 /PRNewswire/ — The China Food and Drug Administration (CFDA) has approved Impulse Dynamics’ Optimizer® system for treatment of chronic heart failure. The announcement was made on December 12, 2017 by Impulse Dynamics’ CEO, Dr. Simos Kedikoglou. “This is a major milestone for Impulse Dynamics, as it will help us offer Cardiac Contractility Modulation therapy […]
China successfully completes the country’s first human implantation of a retrievable transcatheter aortic valve
HANGZHOU, China, Nov. 28, 2017 /PRNewswire/ — The first human implantation of the VenusA Plus retrievable valve system was completed successfully at the Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) on November 23, 2017. Prof. Wang Jian‘an, president of SAHZU, announced that China has completed its first successful human implantation of a retrievable transcatheter aortic valve. It marks […]
CryoLife Announces Enrollment of First Patients in BioGlue Clinical Trial in China
ATLANTA, Nov. 6, 2017 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY),a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that enrollment has started in the Company’s BioGlue clinical trial in China. The results from the trial will serve as the basis of the Company’s regulatory submission to the Chinese Food and […]
LivaNova (LIVN) And MicroPort Scientific (MCRPF) Announce The Approval Of Rega Pacemakers By The China Food And Drug Administration
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”), today announced that the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC” or the “joint venture”) obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration. Not only are Rega pacemakers the first manufactured by MSC, […]
Venus Medtech’s TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China
HANGZHOU, China, April 28, 2017 /PRNewswire/ — Venus Medtech (Hangzhou) Inc., announced on April 25th that its transcatheter aortic valve system – Venus A-valve – has been approved by China Food and Drug Administration(“CFDA”) (registration no.: 20173460680) for sale in China. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation (“TAVR, TAVI”) device in China, […]