Menlo Park, Calif. and Beijing, China — CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced three-month clinical and echocardiographic results of PARACHUTE China, a study of 31 Chinese patients treated consecutively with the company’s Parachute® Ventricular Partitioning Device.
“The results of this study, which met its primary and secondary endpoints, continue to substantiate the safety profile and effectiveness of the Parachute as a viable minimally invasive ventricular partitioning device for patients with ischemic heart failure,” said Gao Runlin, M.D, chief cardiologist at Fu Wai Hospital, Chinese Academy of Medical Sciences, and co-principal investigator of the trial, who presented the results at the China Interventional Therapeutics (CIT) 2015 conference in Beijing. “The very compelling data from these Chinese patients demonstrates the clear promise of this breakthrough technology and is consistent with previous data reported from Europe and the United States.”
The primary endpoint of left ventricular end systolic volume index (LVESVi) reduction as compared to baseline was met by a reduction from 78.2±20.3 ml/m2at baseline to 53.4±17.4 ml/m2 at three-month follow-up, which was found to be highly significant (p < 0.0001). The three-month highlights from the data include:
• Very high procedural success rate of 97 percent
• Secondary Safety Endpoint: Device or Procedure Related MACE rate of 3 percent
• Secondary Efficacy Endpoints Achieved
o NYHA functional class improved from 2.1 to 1.4 (p < 0.001)
o EQ5D VAS Score improved from 64 to 76 (p < 0.01)
• Hemodynamic Improvement
o Ejection Fraction improved from 29.8% to 36.1% (p < 0.0001)
o Wall Motion Severity Index improved from 2.6 to 2.0 (p < 0.0001)
o Stroke Work indexed to End Diastolic Volume improved from 29.4 mmHg to 35.9 mmHg (p < 0.001)
“The PARACHUTE China trial is the fourth trial to demonstrate statistically and clinically meaningful results from our clinical program. The achievement of meeting the primary and secondary endpoints of the China study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are highly encouraged by the Chinese investigators’ enthusiasm for the Parachute device where already more than 50 patients have been treated through clinical trials or special access programs from nine hospitals. The Parachute can address a significant unmet need in the care of heart failure patients in China.”
About PARACHUTE China
PARACHUTE China (clinicaltrials.gov/NCT02240940) enrolled NYHA II to ambulatory IV ischemic heart failure patients with ejection fraction 15-40% to support the regulatory submission for the Parachute device to the China Food and Drug Administration (CFDA). The primary endpoint of the study is reduction in left ventricle end systolic volume index (LVESVi) at three months, which was analyzed at an echocardiography core lab, Yale Cardiovascular Research Group.
The principal investigator is Gao Runlin, M.D, Chief Cardiologist, Fu Wai Hospital, Chinese Academy of Medical Sciences. Huo Yong, M.D., director of the Heart Center and Department of Cardiology PKU-1st Hospital, and president, Chinese Society of Cardiology, and Yang Yuejin, M.D., Ph.D., vice president of Cardiovascular Institute and Fu Wai Hospital, serve as co-principal investigators.
About Heart Failure
Heart failure is a common, debilitating, and potentially deadly condition in which the heart is unable to supply sufficient blood flow to meet the needs of the body. Symptoms of heart failure negatively impact quality of life and include shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues (edema), fatigue, lack of appetite or nausea, impaired thinking, and increased heart rate. More than 20 million people around the world are affected.
About the Parachute® Ventricular Partitioning Device
After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output, which results in heart failure symptoms such as shortness of breath. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. The procedure is performed in the catheterization laboratory under limited sedation. Clinical data demonstrates improved overall cardiac function and quality of life for patients treated with the Parachute device.
The Parachute Ventricular Partitioning Device received CE Mark in 2011. In the U.S., the Parachute system is an investigational device limited by federal law to investigational use only and is not available for sale.
About CardioKinetix Inc.
CardioKinetix, based in Menlo Park, Calif., is pioneering the catheter-based Parachute® Ventricular Partitioning Device for heart failure. Privately held, the company is backed by U.S. Venture Partners, Tekla Healthcare Investors (NYSE:HQH), Tekla Life Sciences Investors (NYSE:HQL), SV Life Sciences, Panorama Capital, New Leaf Venture Partners, Lexington Private Equity, and Edwards Lifesciences.
For more information please visit www.cardiokinetix.com.