10.23.14
Menlo Park, Calif.-based CardioKinetix Inc., a medical device company developing a catheter-based treatment for heart failure, has begun enrollment for its Parachute trial in China. The multi-center trial will evaluate the minimally invasive Parachute ventricular partitioning device for the treatment of heart failure.
The first ten patients were treated with the Parachute device in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.
“I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure,” said Gao Runlin, M.D, chief cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences and principal investigator of the trial. “I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”
Parachute China will enroll ischemic heart failure patients that fall between the New York Heart Association functional classifications of II and IV to support the regulatory submission for the Parachute device to the China Food and Drug Administration. The primary endpoint of the study is reduction in left ventricle end systolic volume index at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our Parachute IV U.S. pivotal trial and the initial commercialization in key European centers under CE mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”
The Parachute ventricular partitioning device received CE mark in 2011. In the United States, the Parachute system is an investigational device.
The first ten patients were treated with the Parachute device in Beijing at Peking University and Fu Wai Hospital, and in Shanghai at Shanghai Tenth People’s Hospital.
“I am thrilled to be pioneering this exciting therapy in China with my colleagues, where there is a significant need for better treatments for heart failure,” said Gao Runlin, M.D, chief cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences and principal investigator of the trial. “I am very proud that the first clinical trial cases were performed last week with such high interest by the study investigators, building upon the early, positive experience with the Parachute by leading cardiovascular centers in China.”
Parachute China will enroll ischemic heart failure patients that fall between the New York Heart Association functional classifications of II and IV to support the regulatory submission for the Parachute device to the China Food and Drug Administration. The primary endpoint of the study is reduction in left ventricle end systolic volume index at three months, which will be analyzed at an echocardiography core lab, Yale Cardiovascular Research Group. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
“The initiation of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are proud of our efforts to bring the Parachute technology to market on three continents. The initiation of the China trial, along with the active enrollment in our Parachute IV U.S. pivotal trial and the initial commercialization in key European centers under CE mark, illustrate our commitment to developing the Parachute therapy for heart failure globally.”
The Parachute ventricular partitioning device received CE mark in 2011. In the United States, the Parachute system is an investigational device.